Method of using bispecific antibodies that recognize coagulation factor IX and / or activated coagulation factor IX and coagulation factor X and / or activated coagulation factor X

Abstract

The object of this disclosure is to provide pharmaceutical compositions and drug regimens effective for preventing and / or treating bleeding, bleeding-related diseases, or diseases caused by bleeding. The inventors have found that category-fixed dose (CFD) of emicizumab provides comparable therapeutic efficacy and safety to dose per kg (PKD), as well as a simpler and less wasteful regimen, and that it can be administered using an injectable device such as an autoinjector or syringe.

Description

[Technical Field]

[0001] This disclosure generally relates to the field of therapeutic drugs for hemorrhagic disorders. [Background technology]

[0002] Hemophilia is a bleeding disorder caused by a congenital deficiency or dysfunction of coagulation factor VIII (FVIII) or coagulation factor IX (FIX). The former is called hemophilia A, and the latter is called hemophilia B. The genes for both factors are located on the X chromosome, and the genetic abnormalities are inherited recessively via X-linked inheritance, so more than 99% of patients who develop the disease are male. The prevalence is known to be approximately 1 per 10,000 male births, and the ratio of hemophilia A to hemophilia B is approximately 5:1.

[0003] The severity of hemophilia A is defined by the FVIII activity in the blood. Patients with less than 1% activity are classified as severe, those with 1% to 5% activity are classified as moderate, and those with more than 5% but less than 40% activity are classified as mild. Severe hemophilia patients, who make up about half of all hemophilia A patients, experience bleeding symptoms several times a month, and this frequency is significantly higher than in moderate and mild patients.

[0004] In patients with hemophilia A, FVIII preparations are generally administered on demand to manage bleeding (on-demand therapy). In recent years, FVIII preparations have also been administered prophylactically to prevent bleeding events (regular replacement therapy; Non-Patent Literature 1 and 2). Although FVIII preparations are mainly administered at home, the difficulty of securing vascular access due to intravenous administration is a problem. Therefore, there is a strong need for a drug that is less burdensome to administer compared to FVIII preparations.

[0005] Occasionally, antibodies against FVIII (inhibitors) develop in hemophilia A patients. Such inhibitors counteract the effects of FVIII preparations. In patients with inhibitors (inhibitor patients), bypass preparations are administered to control bleeding. The mechanism of action of bypass preparations is independent of the function of FVIII, namely its function of catalyzing the activation of coagulation factor X (FX) by activated coagulation factor IX (FIXa). Therefore, in some cases, bypass preparations cannot adequately stop bleeding. Recently, results suggesting the effectiveness of regular administration of bypass preparations have been obtained, but they do not provide sufficient bleeding control compared to FVIII preparations. Therefore, there is a strong need for subcutaneously administered therapeutic agents, regardless of the presence of inhibitors, and long-acting therapeutic agents that can be administered at lower frequencies.

[0006] Recently, as a means of solving this problem, emicizumab (trade name: Hemlibra / ACE910 / RO5534262), an antibody that substitutes for the function of FVIII, and its use have been disclosed (Patent Documents 1, 2, 3, 4, and 5; Non-Patent Documents 3, 4, 5, and 6).

[0007] Emicizumab is a recombinant humanized bispecific antibody that (a1) binds to FIX and / or FIXa and (a2) FX and / or activated blood coagulation factor FX (FXa), and substitutes for the cofactor function of FVIII. Emicizumab is approved in more than 100 countries, including the United States and Japan, as a recombinant drug to suppress bleeding tendencies in patients with hemophilia A. This product is a long-acting subcutaneous formulation that allows for low-frequency administration, i.e., subcutaneous administration of 3 mg / kg(body weight) per dose four times at one-week intervals, followed by 1.5 mg / kg(body weight) per dose weekly, 3 mg / kg(body weight) per dose every two weeks, or 6 mg / kg(body weight) per dose every four weeks. Dosage regimens for emicizumab are described (Patent Documents 6 and 7).

[0008] On the other hand, in order to reduce the amount of waste solution remaining in the vial of emicizumab, several reports have evaluated the possibility of increasing or decreasing the weight-based dose of emicizumab (e.g., per-kg dosing) and the dosing interval (Non-Patent Documents 7 to 11). However, no specialized study has been reported that justifies the clinical application of a fixed dose of emicizumab based on a weight range (referred to herein interchangeably as "categorized flat dosing" or "CFD") from the viewpoint of efficacy and safety. PRIOR ART DOCUMENTS PATENT DOCUMENTS

[0009] PATENT DOCUMENT 1 WO 2005 / 035754 PATENT DOCUMENT 2 WO 2005 / 035756 PATENT DOCUMENT 3 WO 2006 / 109592 PATENT DOCUMENT 4 WO 2012 / 067176 PATENT DOCUMENT 5 WO 2015 / 194233 PATENT DOCUMENT 6 WO 2018 / 047813 PATENT DOCUMENT 7 WO 2021 / 070885 NON-PATENT DOCUMENTS

[0010] NON-PATENT DOCUMENT 1 Blood 58, 1-13 (1981) NON-PATENT DOCUMENT 2 Nature 312, 330-337 (1984) NON-PATENT DOCUMENT 3 Nature Medicine 18, 1570-1574(2012) NON-PATENT DOCUMENT 4 PLOS ONE 8, 1-13(2013) [Non-Patent Document 5] J Thromb Haemost. 12, 206-213(2014) [Non-Patent Document 6] Blood 127(13), 1633-1641(2016) [Non-Patent Document 7] United Kingdom Haemophilia Centers Doctors' Organization (UKHCDO), Maintenance Dose table for Emicizumab (Hemlibra) for Haemophilia A in patients without an inhibitor (last updated: August 2019), http: / / www.ukhcdo.org / ukhcdo-emi-dose-table-final / [Non-Patent Document 8] Research and Practice in Thrombosis and Haemostasis Volume 7, Issue 2, 100074 (2023) [Non-Patent Document 9] Thrombosis and Haemostasis Volume 122, Issue 02, 208-215 (2022) [Non-Patent Document 10] Journal of Managed Care & Specialty Pharmacy Volume 29, Number 1, 47-57 (2022) [Non-Patent Document 11] Haemophilia Volume 27, Issue 3, 358-365 (2021) [Overview of the Initiative] [Problems that the invention aims to solve]

[0011] The purpose of this disclosure is to provide fixed doses of emicizumab based on a category-specific weight range. [Means for solving the problem]

[0012] As a result of specialized research, the inventors have found that, for example, category-based fixed dose (CFD) regimens of emicizumab, as shown in Table 1, can provide comparable therapeutic efficacy and safety to doses per kg (PKD), as well as a simpler and less wasteful regimen. In some embodiments, CFD regimens can reduce drug delivery errors compared to PKD.

[0013] Specifically, this disclosure relates to the following: [1] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a) to (h) below, administered to the patient every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the following group (i) to (t), and is administered to the patient every four weeks. Pharmaceutical composition: (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) For patients weighing 140 kg or more and less than 165 kg, a maintenance dose of 450 mg; (i) A maintenance dose of 135 mg for patients weighing 21 kg or more but less than 25 kg; (j) For patients weighing 25 kg or more but less than 30 kg, a maintenance dose of 165 mg; (k) For patients weighing 30 kg or more but less than 35 kg, a maintenance dose of 195 mg; (l) A maintenance dose of 225 mg for patients weighing 35 kg or more and less than 41 kg; (m) For patients weighing 41 kg or more and less than 50 kg, a maintenance dose of 270 mg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more and less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg. [1-1] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a-1) to (g-1) below, administered to the patient every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the group (h-1) to (r-1) below, and is administered to the patient every four weeks. Pharmaceutical composition: (a-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 135 mg; (b-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 195 mg; (c-1) For patients weighing 76 kg or more and less than 83 kg, a maintenance dose of 225 mg; (d-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 270 mg; (e-1) A maintenance dose of 330 mg for patients weighing 111 kg or more but less than 120 kg; (f-1) For patients weighing 131 kg or more but less than 140 kg, a maintenance dose of 390 mg; (g-1) A maintenance dose of 450 mg for patients weighing 151 kg or more and less than 165 kg; (h-1) For patients weighing 23 kg or more but less than 25 kg, a maintenance dose of 135 mg; (i-1) For patients weighing 28 kg or more but less than 30 kg, a maintenance dose of 165 mg; (j-1) For patients weighing 33 kg or more but less than 35 kg, a maintenance dose of 195 mg; (k-1) For patients weighing 38 kg or more and less than 41 kg, a maintenance dose of 225 mg; (l-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 270 mg; (m-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 390 mg; (n-1) A maintenance dose of 450 mg for patients weighing 76 kg or more and less than 83 kg; (o-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 540 mg; (p-1) For patients weighing 111 kg or more but less than 120 kg, a maintenance dose of 660 mg; (q-1) A maintenance dose of 780 mg for patients weighing 131 kg or more and less than 140 kg; and (r-1) A maintenance dose of 900 mg for patients weighing 151 kg or more and less than 165 kg. [1-2] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a-2) to (h-2) below, administered to the patient every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the group (i-2) to (t-2) below, and is administered to the patient every four weeks. Pharmaceutical composition: (a-2) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 45 kg, and for patients weighing more than 45 kg but less than 50 kg; (b-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 165 mg; (c-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 195 mg; (d-2) For patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a maintenance dose of 225 mg; (e-2) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (f-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 330 mg; (g-2) For patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a maintenance dose of 390 mg; (h-2) For patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a maintenance dose of 450 mg; (i-2) For patients weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg, a maintenance dose of 135 mg; (j-2) For patients weighing 25 kg or more but less than 27.5 kg, and greater than 27.5 kg but less than 30 kg, a maintenance dose of 165 mg; (k-2) For patients weighing 30 kg or more but less than 32.5 kg, and greater than 32.5 kg but less than 35 kg, the maintenance dose is 195 mg; (l-2) For patients weighing 35 kg or more but less than 37.5 kg, and greater than 37.5 kg but less than 41 kg, a maintenance dose of 225 mg; (m-2) For patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 270 mg; (n-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 330 mg; (o-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 390 mg; (p-2) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (q-2) For patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a maintenance dose of 540 mg; (r-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 660 mg; (s-2) For patients weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg, a maintenance dose of 780 mg; and (t-2) A maintenance dose of 900 mg for patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [2] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The bispecific antibody is The patient is administered a single dose of a bispecific antibody selected from the group consisting of (a) to (h) below, every two weeks, as a maintenance dose in the pharmaceutical composition; or The pharmaceutical composition is administered to the patient every four weeks as a single dose, consisting of a maintenance dose of a bispecific antibody selected from the group (i) to (t) below. Bispecific antibodies: (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) For patients weighing 140 kg or more and less than 165 kg, a maintenance dose of 450 mg; (i) A maintenance dose of 135 mg for patients weighing 21 kg or more but less than 25 kg; (j) For patients weighing 25 kg or more but less than 30 kg, a maintenance dose of 165 mg; (k) For patients weighing 30 kg or more but less than 35 kg, a maintenance dose of 195 mg; (l) A maintenance dose of 225 mg for patients weighing 35 kg or more and less than 41 kg; (m) For patients weighing 41 kg or more and less than 50 kg, a maintenance dose of 270 mg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more and less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg. [2-1] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The bispecific antibody is The pharmaceutical composition is administered to the patient every two weeks as a single dose, in the form of a maintenance dose of a bispecific antibody selected from the group consisting of (a-1) to (g-1) below; or The pharmaceutical composition is administered to the patient every four weeks as a single dose, consisting of a maintenance dose of a bispecific antibody selected from the group (h-1) to (r-1) below. Bispecific antibodies: (a-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 135 mg; (b-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 195 mg; (c-1) For patients weighing 76 kg or more and less than 83 kg, a maintenance dose of 225 mg; (d-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 270 mg; (e-1) A maintenance dose of 330 mg for patients weighing 111 kg or more but less than 120 kg; (f-1) For patients weighing 131 kg or more but less than 140 kg, a maintenance dose of 390 mg; (g-1) A maintenance dose of 450 mg for patients weighing 151 kg or more and less than 165 kg; (h-1) For patients weighing 23 kg or more but less than 25 kg, a maintenance dose of 135 mg; (i-1) For patients weighing 28 kg or more but less than 30 kg, a maintenance dose of 165 mg; (j-1) For patients weighing 33 kg or more but less than 35 kg, a maintenance dose of 195 mg; (k-1) For patients weighing 38 kg or more and less than 41 kg, a maintenance dose of 225 mg; (l-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 270 mg; (m-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 390 mg; (n-1) A maintenance dose of 450 mg for patients weighing 76 kg or more and less than 83 kg; (o-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 540 mg; (p-1) For patients weighing 111 kg or more but less than 120 kg, a maintenance dose of 660 mg; (q-1) A maintenance dose of 780 mg for patients weighing 131 kg or more and less than 140 kg; and (r-1) A maintenance dose of 900 mg for patients weighing 151 kg or more and less than 165 kg. [2-2] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The bispecific antibody is The pharmaceutical composition is administered to the patient every two weeks as a single dose, in the form of a maintenance dose of a bispecific antibody selected from the group consisting of (a-2) to (h-2) below; or The pharmaceutical composition is administered to the patient every four weeks as a maintenance dose of a bispecific antibody selected from the group consisting of (i-2) to (t-2) below. Bispecific antibodies: (a-2) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 45 kg, and for patients weighing more than 45 kg but less than 50 kg; (b-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 165 mg; (c-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 195 mg; (d-2) For patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a maintenance dose of 225 mg; (e-2) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (f-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 330 mg; (g-2) For patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a maintenance dose of 390 mg; (h-2) For patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a maintenance dose of 450 mg; (i-2) For patients weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg, a maintenance dose of 135 mg; (j-2) For patients weighing 25 kg or more but less than 27.5 kg, and greater than 27.5 kg but less than 30 kg, a maintenance dose of 165 mg; (k-2) For patients weighing 30 kg or more but less than 32.5 kg, and greater than 32.5 kg but less than 35 kg, the maintenance dose is 195 mg; (l-2) For patients weighing 35 kg or more but less than 37.5 kg, and greater than 37.5 kg but less than 41 kg, a maintenance dose of 225 mg; (m-2) For patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 270 mg; (n-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 330 mg; (o-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 390 mg; (p-2) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (q-2) For patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a maintenance dose of 540 mg; (r-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 660 mg; (s-2) For patients weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg, a maintenance dose of 780 mg; and (t-2) A maintenance dose of 900 mg for patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [3] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a) to (h) below, administered every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the group (i) to (t) below, and is administered every four weeks. method: (a) A maintenance dose of 135 mg for subjects weighing 41 kg or more and less than 50 kg; (b) A maintenance dose of 165 mg for subjects weighing 50 kg or more but less than 60 kg; (c) For subjects weighing 60 kg or more but less than 70 kg, the maintenance dose is 195 mg; (d) For subjects weighing 70 kg or more but less than 83 kg, a maintenance dose of 225 mg; (e) A maintenance dose of 270 mg for subjects weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for subjects weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for subjects weighing 120 kg or more and less than 140 kg; (h) For subjects weighing 140 kg or more and less than 165 kg, a maintenance dose of 450 mg; (i) A maintenance dose of 135 mg for subjects weighing 21 kg or more and less than 25 kg; (j) For subjects weighing 25 kg or more but less than 30 kg, the maintenance dose is 165 mg; (k) For subjects weighing 30 kg or more but less than 35 kg, the maintenance dose is 195 mg; (l) For subjects weighing 35 kg or more and less than 41 kg, a maintenance dose of 225 mg; (m) For subjects weighing 41 kg or more and less than 50 kg, a maintenance dose of 270 mg; (n) A maintenance dose of 330 mg for subjects weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for subjects weighing 60 kg or more but less than 70 kg; (p) For subjects weighing 70 kg or more and less than 83 kg, a maintenance dose of 450 mg; (q) For subjects weighing 83 kg or more and less than 100 kg, a maintenance dose of 540 mg; (r) For subjects weighing 100 kg or more but less than 120 kg, a maintenance dose of 660 mg; (s) A maintenance dose of 780 mg for subjects weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for subjects weighing 140 kg or more and less than 165 kg. [3-1] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a-1) to (g-1) below, administered every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the group (h-1) to (r-1) below, administered every four weeks. method: (a-1) For subjects weighing 48 kg or more and less than 50 kg, the maintenance dose is 135 mg; (b-1) For subjects weighing 66 kg or more and less than 70 kg, the maintenance dose is 195 mg; (c-1) For subjects weighing 76 kg or more and less than 83 kg, the maintenance dose is 225 mg; (d-1) For subjects weighing 99 kg or more and less than 100 kg, a maintenance dose of 270 mg; (e-1) For subjects weighing 111 kg or more and less than 120 kg, a maintenance dose of 330 mg; (f-1) For subjects weighing 131 kg or more and less than 140 kg, a maintenance dose of 390 mg; (g-1) A maintenance dose of 450 mg for subjects weighing 151 kg or more and less than 165 kg; (h-1) For subjects weighing 23 kg or more and less than 25 kg, the maintenance dose is 135 mg; (i-1) For subjects weighing 28 kg or more and less than 30 kg, the maintenance dose is 165 mg; (j-1) For subjects weighing 33 kg or more and less than 35 kg, the maintenance dose is 195 mg; (k-1) For subjects weighing 38 kg or more and less than 41 kg, the maintenance dose is 225 mg; (l-1) For subjects weighing 48 kg or more and less than 50 kg, a maintenance dose of 270 mg; (m-1) For subjects weighing 66 kg or more and less than 70 kg, a maintenance dose of 390 mg; (n-1) For subjects weighing 76 kg or more and less than 83 kg, a maintenance dose of 450 mg; (o-1) For subjects weighing 99 kg or more and less than 100 kg, a maintenance dose of 540 mg; (p-1) For subjects weighing 111 kg or more and less than 120 kg, a maintenance dose of 660 mg; (q-1) For subjects weighing 131 kg or more and less than 140 kg, a maintenance dose of 780 mg; and (r-1) A maintenance dose of 900 mg for subjects weighing 151 kg or more and less than 165 kg. [3-2] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a-2) to (h-2) below, administered every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the group (i-2) to (t-2) below, administered every four weeks. method: (a-2) For subjects weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 135 mg; (b-2) For subjects weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, the maintenance dose is 165 mg; (c-2) For subjects weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, the maintenance dose is 195 mg; (d-2) For subjects weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, the maintenance dose is 225 mg; (e-2) A maintenance dose of 270 mg for subjects weighing 83 kg or more but less than 90 kg, and more than 90 kg but less than 100 kg; (f-2) For subjects weighing 100 kg or more but less than 110 kg, and those weighing more than 110 kg but less than 120 kg, a maintenance dose of 330 mg; (g-2) For subjects weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg, the maintenance dose is 390 mg; (h-2) For subjects weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a maintenance dose of 450 mg; (i-2) For subjects weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg, a maintenance dose of 135 mg; (j-2) For subjects weighing 25 kg or more but less than 27.5 kg, and greater than 27.5 kg but less than 30 kg, a maintenance dose of 165 mg; (k-2) A maintenance dose of 195 mg for subjects weighing 30 kg or more but less than 32.5 kg, and greater than 32.5 kg but less than 35 kg; (l-2) For subjects weighing 35 kg or more but less than 37.5 kg, and greater than 37.5 kg but less than 41 kg, a maintenance dose of 225 mg; (m-2) For subjects weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 270 mg; (n-2) For subjects weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 330 mg; (o-2) For subjects weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 390 mg; (p-2) A maintenance dose of 450 mg for subjects weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (q-2) For subjects weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, the maintenance dose is 540 mg; (r-2) For subjects weighing 100 kg or more but less than 110 kg, and more than 110 kg but less than 120 kg, the maintenance dose is 660 mg; (s-2) A maintenance dose of 780 mg for subjects weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg; and (t-2) A maintenance dose of 900 mg for subjects weighing 140 kg or more but less than 150 kg, and more than 150 kg but less than 165 kg. [4] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a) to (h) below, administered to the patient every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the following group (i) to (t), and is administered to the patient every four weeks. use: (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) For patients weighing 140 kg or more and less than 165 kg, a maintenance dose of 450 mg; (i) A maintenance dose of 135 mg for patients weighing 21 kg or more but less than 25 kg; (j) For patients weighing 25 kg or more but less than 30 kg, a maintenance dose of 165 mg; (k) For patients weighing 30 kg or more but less than 35 kg, a maintenance dose of 195 mg; (l) A maintenance dose of 225 mg for patients weighing 35 kg or more and less than 41 kg; (m) For patients weighing 41 kg or more and less than 50 kg, a maintenance dose of 270 mg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more and less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg. [4-1] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a-1) to (g-1) below, administered to the patient every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the group (h-1) to (r-1) below, and is administered to the patient every four weeks. use: (a-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 135 mg; (b-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 195 mg; (c-1) For patients weighing 76 kg or more and less than 83 kg, a maintenance dose of 225 mg; (d-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 270 mg; (e-1) A maintenance dose of 330 mg for patients weighing 111 kg or more but less than 120 kg; (f-1) For patients weighing 131 kg or more but less than 140 kg, a maintenance dose of 390 mg; (g-1) A maintenance dose of 450 mg for patients weighing 151 kg or more and less than 165 kg; (h-1) For patients weighing 23 kg or more but less than 25 kg, a maintenance dose of 135 mg; (i-1) For patients weighing 28 kg or more but less than 30 kg, a maintenance dose of 165 mg; (j-1) For patients weighing 33 kg or more but less than 35 kg, a maintenance dose of 195 mg; (k-1) For patients weighing 38 kg or more and less than 41 kg, a maintenance dose of 225 mg; (l-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 270 mg; (m-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 390 mg; (n-1) A maintenance dose of 450 mg for patients weighing 76 kg or more and less than 83 kg; (o-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 540 mg; (p-1) For patients weighing 111 kg or more but less than 120 kg, a maintenance dose of 660 mg; (q-1) A maintenance dose of 780 mg for patients weighing 131 kg or more and less than 140 kg; and (r-1) A maintenance dose of 900 mg for patients weighing 151 kg or more and less than 165 kg. [4-2] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the group (a-2) to (h-2) below, administered to the patient every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the group (i-2) to (t-2) below, and is administered to the patient every four weeks. use: (a-2) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 45 kg, and for patients weighing more than 45 kg but less than 50 kg; (b-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 165 mg; (c-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 195 mg; (d-2) For patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a maintenance dose of 225 mg; (e-2) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (f-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 330 mg; (g-2) For patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a maintenance dose of 390 mg; (h-2) For patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a maintenance dose of 450 mg; (i-2) For patients weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg, a maintenance dose of 135 mg; (j-2) For patients weighing 25 kg or more but less than 27.5 kg, and greater than 27.5 kg but less than 30 kg, a maintenance dose of 165 mg; (k-2) For patients weighing 30 kg or more but less than 32.5 kg, and greater than 32.5 kg but less than 35 kg, the maintenance dose is 195 mg; (l-2) For patients weighing 35 kg or more but less than 37.5 kg, and greater than 37.5 kg but less than 41 kg, a maintenance dose of 225 mg; (m-2) For patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 270 mg; (n-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 330 mg; (o-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 390 mg; (p-2) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (q-2) For patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a maintenance dose of 540 mg; (r-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 660 mg; (s-2) For patients weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg, a maintenance dose of 780 mg; and (t-2) A maintenance dose of 900 mg for patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [5] A kit for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The kit is, (1) Container; (2) A maintenance dose of a bispecific antibody selected from the group consisting of (a) to (h) below, or a pharmaceutical composition comprising a maintenance dose of a bispecific antibody selected from the group consisting of (i) to (t) below. Includes, The bispecific antibody is administered to the patient in accordance with the instructions optionally included in the kit; and The instruction document states that the bispecific antibody, A single dose is administered every two weeks at a maintenance dose of a bispecific antibody selected from the following groups (a) to (h), or Each dose is administered every four weeks as a maintenance dose of a bispecific antibody selected from the following groups (i) to (t). He instructed them to do so. The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. including, kit: (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) For patients weighing 140 kg or more and less than 165 kg, a maintenance dose of 450 mg; (i) A maintenance dose of 135 mg for patients weighing 21 kg or more but less than 25 kg; (j) For patients weighing 25 kg or more but less than 30 kg, a maintenance dose of 165 mg; (k) For patients weighing 30 kg or more but less than 35 kg, a maintenance dose of 195 mg; (l) A maintenance dose of 225 mg for patients weighing 35 kg or more and less than 41 kg; (m) For patients weighing 41 kg or more and less than 50 kg, a maintenance dose of 270 mg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more and less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg. [5-1] A kit for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The kit is, (1) Container; (2) A pharmaceutical composition comprising a maintenance dose of a bispecific antibody selected from the group consisting of (a-1) to (g-1) below, or a maintenance dose of a bispecific antibody selected from the group consisting of (h-1) to (r-1) below. Includes, The bispecific antibody is administered to the patient in accordance with the instructions optionally included in the kit; and The instruction document states that the bispecific antibody, A single dose is administered every two weeks at a maintenance dose of a bispecific antibody selected from the group consisting of (a-1) to (g-1) below, or Each dose is administered every four weeks as a maintenance dose of a bispecific antibody selected from the following group consisting of (h-1) to (r-1). He instructed them to do so. The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. including, kit: (a-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 135 mg; (b-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 195 mg; (c-1) For patients weighing 76 kg or more and less than 83 kg, a maintenance dose of 225 mg; (d-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 270 mg; (e-1) A maintenance dose of 330 mg for patients weighing 111 kg or more but less than 120 kg; (f-1) For patients weighing 131 kg or more but less than 140 kg, a maintenance dose of 390 mg; (g-1) A maintenance dose of 450 mg for patients weighing 151 kg or more and less than 165 kg; (h-1) For patients weighing 23 kg or more but less than 25 kg, a maintenance dose of 135 mg; (i-1) For patients weighing 28 kg or more but less than 30 kg, a maintenance dose of 165 mg; (j-1) For patients weighing 33 kg or more but less than 35 kg, a maintenance dose of 195 mg; (k-1) For patients weighing 38 kg or more and less than 41 kg, a maintenance dose of 225 mg; (l-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 270 mg; (m-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 390 mg; (n-1) A maintenance dose of 450 mg for patients weighing 76 kg or more and less than 83 kg; (o-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 540 mg; (p-1) For patients weighing 111 kg or more but less than 120 kg, a maintenance dose of 660 mg; (q-1) A maintenance dose of 780 mg for patients weighing 131 kg or more and less than 140 kg; and (r-1) A maintenance dose of 900 mg for patients weighing 151 kg or more and less than 165 kg. [5-2] Kits for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The kit is, (1) Container; (2) A pharmaceutical composition comprising a maintenance dose of a bispecific antibody selected from the group consisting of (a-2) to (h-2) below, or a maintenance dose of a bispecific antibody selected from the group consisting of (i-2) to (t-2) below. Includes, The bispecific antibody is administered to the patient in accordance with the instructions optionally included in the kit; and The instruction document states that the bispecific antibody, A single dose is administered every two weeks as a maintenance dose of a bispecific antibody selected from the group consisting of (a-2) to (h-2) below, or Each dose is administered every four weeks as a maintenance dose of a bispecific antibody selected from the group consisting of (i-2) to (t-2) below. He instructed them to do so. The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. including, kit: (a-2) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 45 kg, and for patients weighing more than 45 kg but less than 50 kg; (b-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 165 mg; (c-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 195 mg; (d-2) For patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a maintenance dose of 225 mg; (e-2) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (f-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 330 mg; (g-2) For patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a maintenance dose of 390 mg; (h-2) For patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a maintenance dose of 450 mg; (i-2) For patients weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg, a maintenance dose of 135 mg; (j-2) For patients weighing 25 kg or more but less than 27.5 kg, and greater than 27.5 kg but less than 30 kg, a maintenance dose of 165 mg; (k-2) For patients weighing 30 kg or more but less than 32.5 kg, and greater than 32.5 kg but less than 35 kg, the maintenance dose is 195 mg; (l-2) For patients weighing 35 kg or more but less than 37.5 kg, and greater than 37.5 kg but less than 41 kg, a maintenance dose of 225 mg; (m-2) For patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 270 mg; (n-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 330 mg; (o-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 390 mg; (p-2) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (q-2) For patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a maintenance dose of 540 mg; (r-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 660 mg; (s-2) For patients weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg, a maintenance dose of 780 mg; and (t-2) A maintenance dose of 900 mg for patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [6] A pharmaceutical composition comprising a bispecific antibody, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The group is selected from the following (C1) to (C20): (C1) A pharmaceutical composition comprising 135 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 41 kg or more and less than 50 kg, administered once every two weeks; (C2) A pharmaceutical composition comprising 165 mg of bispecific antibody for use in administration once every two weeks to patients with congenital hemophilia A who weigh 50 kg or more and less than 60 kg; (C3) A pharmaceutical composition comprising 195 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 60 kg or more but less than 70 kg, administered once every two weeks; (C4) A pharmaceutical composition comprising 225 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 70 kg or more and less than 83 kg, administered once every two weeks; (C5) A pharmaceutical composition comprising 270 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 83 kg or more and less than 100 kg, administered once every two weeks; (C6) A pharmaceutical composition comprising 330 mg of bispecific antibody for use in administration once every two weeks to patients with congenital hemophilia A whose body weight is 100 kg or more and less than 120 kg; (C7) A pharmaceutical composition comprising 390 mg of bispecific antibody for use in administration once every two weeks to patients with congenital hemophilia A whose body weight is 120 kg or more and less than 140 kg; (C8) A pharmaceutical composition comprising 450 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 140 kg or more and less than 165 kg, administered once every two weeks; (C9) A pharmaceutical composition comprising 135 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 21 kg or more and less than 25 kg, administered once every four weeks; (C10) A pharmaceutical composition comprising 165 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 25 kg or more and less than 30 kg, administered once every four weeks; (C11) A pharmaceutical composition containing 195 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 30 kg or more and less than 35 kg, administered once every four weeks; (C12) A pharmaceutical composition comprising 225 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 35 kg or more and less than 41 kg, administered once every four weeks; (C13) A pharmaceutical composition comprising 270 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 41 kg or more and less than 50 kg, administered once every four weeks; (C14) A pharmaceutical composition containing 330 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 50 kg or more and less than 60 kg, administered once every four weeks; (C15) A pharmaceutical composition containing 390 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 60 kg or more and less than 70 kg, administered once every four weeks; (C16) A pharmaceutical composition comprising 450 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 70 kg or more and less than 83 kg, administered once every four weeks; (C17) A pharmaceutical composition containing 540 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 83 kg or more and less than 100 kg, administered once every four weeks; (C18) A pharmaceutical composition containing 660 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh between 100 kg and 120 kg; (C19) A pharmaceutical composition comprising 780 mg of bispecific antibody for use in administration once every four weeks to patients with congenital hemophilia A whose body weight is 120 kg or more and less than 140 kg; and (C20) A pharmaceutical composition containing 900 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 140 kg or more and less than 165 kg, administered once every four weeks. Preferably, the pharmaceutical compositions in (C1) to (C20) contain a bispecific antibody as a single maintenance dose. Pharmaceutical composition. [7] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more and less than 140 kg; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg. Pharmaceutical composition. [7-1](A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more and less than 140 kg; and (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg. [7] The pharmaceutical composition. [7-2] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of coagulation factor VIII (FVIII) and / or activated coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-1) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 48 kg or more and less than 50 kg; (B-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 66 kg or more and less than 70 kg; (C-1) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 76 kg or more and less than 83 kg; (D-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 99 kg or more and less than 100 kg; (E-1) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 111 kg or more and less than 120 kg; (F-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 131 kg or more and less than 140 kg; and / or (G-1) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 151 kg or more and less than 165 kg. Pharmaceutical composition. [7-3] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg; (B-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg; (C-2) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg; (D-2) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg; (E-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (F-2) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more but less than 110 kg, and patients weighing more than 110 kg but less than 120 kg; (G-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (H-2) 450 mg is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg. Pharmaceutical composition. [8] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A) 135 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more and less than 140 kg; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 140 kg or more and less than 165 kg, once every two weeks. Bispecific antibodies. [8-1](A) 135 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 120 kg or more and less than 140 kg; and (H) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 140 kg or more and less than 165 kg, once every two weeks. [8] A bispecific antibody. [8-2] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-1) 135 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 48 kg or more and less than 50 kg; (B-1) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 66 kg or more and less than 70 kg; (C-1) 225 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 76 kg or more and less than 83 kg; (D-1) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 99 kg or more and less than 100 kg; (E-1) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 111 kg or more and less than 120 kg; (F-1) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 131 kg or more and less than 140 kg; and / or (G-1) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 151 kg or more and less than 165 kg, once every two weeks. Bispecific antibodies. [8-3] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-2) 135 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (B-2) 165 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (C-2) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (D-2) 225 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (E-2) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (F-2) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (G-2) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (H-2) 450 mg is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 140 kg or more but less than 150 kg, and more than 150 kg but less than 165 kg. Bispecific antibodies. [9] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 120 kg or more and less than 140 kg; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 140 kg or more and less than 165 kg. method. [9-1](A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 120 kg or more and less than 140 kg; and (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 140 kg or more and less than 165 kg. Method [9]. [9-2] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-1) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 48 kg or more and less than 50 kg; (B-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 66 kg or more and less than 70 kg; (C-1) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 76 kg or more and less than 83 kg; (D-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 99 kg or more and less than 100 kg; (E-1) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 111 kg or more and less than 120 kg; (F-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 131 kg or more and less than 140 kg; and / or (G-1) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 151 kg or more and less than 165 kg. method. [9-3] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (B-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (C-2) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (D-2) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (E-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (F-2) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (G-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (H-2) 450 mg is administered as a single maintenance dose once every two weeks to subjects weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. method.

[10] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more and less than 140 kg; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg. use. [10-1](A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more and less than 140 kg; and (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg. Use of

[10] . [10-2] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-1) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 48 kg or more and less than 50 kg; (B-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 66 kg or more and less than 70 kg; (C-1) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 76 kg or more and less than 83 kg; (D-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 99 kg or more and less than 100 kg; (E-1) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 111 kg or more and less than 120 kg; (F-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 131 kg or more and less than 140 kg; and / or (G-1) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 151 kg or more and less than 165 kg. use. [10-3] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg; (B-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg; (C-2) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg; (D-2) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg; (E-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (F-2) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more but less than 110 kg, and patients weighing more than 110 kg but less than 120 kg; (G-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (H-2) 450 mg is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg. use.

[11] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; and / or (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. Pharmaceutical composition. [11-1](I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. The pharmaceutical composition of

[11] . [11-2] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, A bispecific antibody (H-1) 135 mg is administered as a single maintenance dose once every four weeks to patients weighing 23 kg or more and less than 25 kg; (I-1) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 28 kg or more and less than 30 kg; (J-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 33 kg or more and less than 35 kg; A bispecific antibody (K-1) 225 mg is administered as a single maintenance dose once every four weeks to patients weighing 38 kg or more and less than 41 kg; (L-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 48 kg or more and less than 50 kg; (M-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 66 kg or more and less than 70 kg; A bispecific antibody (N-1) 450 mg is administered as a single maintenance dose once every four weeks to patients weighing 76 kg or more and less than 83 kg; A bispecific antibody of (O-1) 540 mg is administered as a single maintenance dose once every four weeks to patients weighing 99 kg or more but less than 100 kg; A bispecific antibody (P-1) 660 mg is administered as a single maintenance dose once every four weeks to patients weighing 111 kg or more and less than 120 kg; (Q-1) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (R-1) 900 mg is administered as a single maintenance dose once every four weeks to patients weighing 151 kg or more and less than 165 kg. Pharmaceutical composition. [11-3] A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg; (J-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more but less than 27.5 kg, and patients weighing more than 27.5 kg but less than 30 kg; A bispecific antibody (K-2) 195 mg is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 32.5 kg, and patients weighing more than 32.5 kg but less than 35 kg; A bispecific antibody (L-2)225 mg is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more but less than 37.5 kg, and patients weighing more than 37.5 kg but less than 41 kg; (M-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg; A bispecific antibody of (N-2)330 mg is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg; A single maintenance dose of (O-2) 390 mg of bispecific antibody is administered once every four weeks to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg; A bispecific antibody (P-2) 450 mg is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg; (Q-2) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more but less than 90 kg, and patients weighing more than 90 kg but less than 100 kg; A single maintenance dose of (R-2) 660 mg of bispecific antibody is administered once every four weeks to patients weighing 100 kg or more but less than 110 kg, and patients weighing more than 110 kg but less than 120 kg; (S-2) 780 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose to patients with a body weight of 120 kg or more and less than 130 kg, and more than 130 kg and less than 140 kg; and / or (T-2) 900 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose to patients with a body weight of 140 kg or more and less than 150 kg, and more than 150 kg and less than 165 kg, A pharmaceutical composition.

[12] A bispecific antibody for use in the treatment of a disease and / or reduction in the incidence of a disease, wherein the disease develops and / or progresses due to the reduction or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody A first polypeptide, which is a heavy chain comprising a heavy chain variable region comprising the amino acid sequences of CDR1, 2, and 3 of SEQ ID NO: 1, 2, and 3, respectively; A second polypeptide, which is a heavy chain comprising a heavy chain variable region comprising the amino acid sequences of CDR1, 2, and 3 of SEQ ID NO: 6, 7, and 8, respectively; and Third and fourth polypeptides, which are a common light chain comprising a light chain variable region comprising the amino acid sequences of CDR1, 2, and 3 of SEQ ID NO: 11, 12, and 13, respectively comprises (I) 135 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to a patient with a body weight of 21 kg or more and less than 25 kg; (J) 165 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to a patient with a body weight of 25 kg or more and less than 30 kg; (K) 195 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to a patient with a body weight of 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more and less than 140 kg; and / or (T) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 140 kg or more and less than 165 kg. Bispecific antibodies. [12-1](I) 135 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 140 kg or more and less than 165 kg.

[12] A bispecific antibody. [12-2] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (H-1) 135 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 23 kg or more and less than 25 kg; (I-1) 165 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 28 kg or more and less than 30 kg; (J-1) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 33 kg or more and less than 35 kg; (K-1) 225 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 38 kg or more and less than 41 kg; (L-1) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 48 kg or more and less than 50 kg; (M-1) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 66 kg or more and less than 70 kg; (N-1) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 76 kg or more and less than 83 kg; (O-1) 540 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 99 kg or more and less than 100 kg; (P-1) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 111 kg or more and less than 120 kg; (Q-1) 780 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 131 kg or more and less than 140 kg; and / or (R-1) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 151 kg or more and less than 165 kg. Bispecific antibodies. [12-3] Bispecific antibodies for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I-2) 135 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg; (J-2) 165 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 25 kg or more but less than 27.5 kg, and patients weighing more than 27.5 kg but less than 30 kg; (K-2) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 30 kg or more but less than 32.5 kg, and greater than 32.5 kg but less than 35 kg; (L-2)225 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 35 kg or more but less than 37.5 kg, and greater than 37.5 kg but less than 41 kg; (M-2) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (N-2)330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (O-2)390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (P-2) 450 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to patients with a body weight of 70 kg or more and less than 75 kg, and more than 75 kg and less than 83 kg; (Q-2) 540 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to patients with a body weight of 83 kg or more and less than 90 kg, and more than 90 kg and less than 100 kg; (R-2) 660 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to patients with a body weight of 100 kg or more and less than 110 kg, and more than 110 kg and less than 120 kg; (S-2) 780 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to patients with a body weight of 120 kg or more and less than 130 kg, and more than 130 kg and less than 140 kg; and / or (T-2) 900 mg of the bispecific antibody is administered once every 4 weeks as a single maintenance dose in the pharmaceutical composition to patients with a body weight of 140 kg or more and less than 150 kg, and more than 150 kg and less than 165 kg, The bispecific antibody.

[13] A method for treating a disease in a subject and / or reducing the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency in the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method comprises the step of administering to the subject a pharmaceutical composition comprising the bispecific antibody, The bispecific antibody, A first polypeptide, which is an H chain comprising an H chain variable region comprising the amino acid sequences of CDR1, 2, and 3 of SEQ ID NO: 1, 2, and 3, respectively; A second polypeptide, which is an H chain comprising an H chain variable region comprising the amino acid sequences of CDR1, 2, and 3 of SEQ ID NO: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing between 100 kg and 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 120 kg or more and less than 140 kg; and / or (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 140 kg or more and less than 165 kg. method. [13-1](I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing between 100 kg and 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 140 kg or more and less than 165 kg.

[13] The method. [13-2] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, A bispecific antibody (H-1) 135 mg is administered as a single maintenance dose once every four weeks to subjects weighing 23 kg or more and less than 25 kg; (I-1) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 28 kg or more and less than 30 kg; (J-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 33 kg or more and less than 35 kg; A bispecific antibody (K-1) 225 mg is administered as a single maintenance dose once every four weeks to subjects weighing 38 kg or more and less than 41 kg; (L-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 48 kg or more and less than 50 kg; (M-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 66 kg or more and less than 70 kg; A bispecific antibody (N-1) 450 mg is administered as a single maintenance dose once every four weeks to subjects weighing 76 kg or more and less than 83 kg; (O-1) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 99 kg or more and less than 100 kg; (P-1) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 111 kg or more and less than 120 kg; (Q-1) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (R-1) 900 mg is administered as a single maintenance dose once every four weeks to subjects weighing 151 kg or more and less than 165 kg. method. [13-3] A method for treating a disease and / or reducing the incidence of the disease in a subject, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The method includes the step of administering a pharmaceutical composition containing a bispecific antibody to the subject, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg; (J-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 25 kg or more but less than 27.5 kg, and greater than 27.5 kg but less than 30 kg; A bispecific antibody (K-2) 195 mg is administered as a single maintenance dose once every four weeks to subjects weighing 30 kg or more but less than 32.5 kg, and greater than 32.5 kg but less than 35 kg; A bispecific antibody (L-2)225 mg is administered as a single maintenance dose once every four weeks to subjects weighing 35 kg or more but less than 37.5 kg, and greater than 37.5 kg but less than 41 kg; (M-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; A bispecific antibody (N-2)330 mg is administered as a single maintenance dose once every four weeks to subjects weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (O-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; A bispecific antibody (P-2) 450 mg is administered as a single maintenance dose once every four weeks to subjects weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (Q-2) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; A bispecific antibody (R-2) 660 mg is administered as a single maintenance dose once every four weeks to subjects weighing 100 kg or more but less than 110 kg, and those weighing more than 110 kg but less than 120 kg; (S-2) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to subjects weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody (T-2) 900 mg is administered as a single maintenance dose once every four weeks to subjects weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. method.

[14] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of coagulation factor VIII (FVIII) and / or activated coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; and / or (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. use. [14-1](I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. Use of

[14] . [14-2] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of coagulation factor VIII (FVIII) and / or activated coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, A bispecific antibody (H-1) 135 mg is administered as a single maintenance dose once every four weeks to patients weighing 23 kg or more and less than 25 kg; (I-1) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 28 kg or more and less than 30 kg; (J-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 33 kg or more and less than 35 kg; A bispecific antibody (K-1) 225 mg is administered as a single maintenance dose once every four weeks to patients weighing 38 kg or more and less than 41 kg; (L-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 48 kg or more and less than 50 kg; (M-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 66 kg or more and less than 70 kg; A bispecific antibody (N-1) 450 mg is administered as a single maintenance dose once every four weeks to patients weighing 76 kg or more and less than 83 kg; A bispecific antibody of (O-1) 540 mg is administered as a single maintenance dose once every four weeks to patients weighing 99 kg or more but less than 100 kg; A bispecific antibody (P-1) 660 mg is administered as a single maintenance dose once every four weeks to patients weighing 111 kg or more and less than 120 kg; (Q-1) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (R-1) 900 mg is administered as a single maintenance dose once every four weeks to patients weighing 151 kg or more and less than 165 kg. use. [14-3] Use of bispecific antibodies in the manufacture of a pharmaceutical composition for treating a disease and / or reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more but less than 22.5 kg, and greater than 22.5 kg but less than 25 kg; (J-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more but less than 27.5 kg, and patients weighing more than 27.5 kg but less than 30 kg; A bispecific antibody (K-2) 195 mg is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 32.5 kg, and patients weighing more than 32.5 kg but less than 35 kg; A bispecific antibody (L-2)225 mg is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more but less than 37.5 kg, and patients weighing more than 37.5 kg but less than 41 kg; (M-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg; A bispecific antibody of (N-2)330 mg is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg; A single maintenance dose of (O-2) 390 mg of bispecific antibody is administered once every four weeks to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg; A bispecific antibody (P-2) 450 mg is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg; (Q-2) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more but less than 90 kg, and patients weighing more than 90 kg but less than 100 kg; A single maintenance dose of (R-2) 660 mg of bispecific antibody is administered once every four weeks to patients weighing 100 kg or more but less than 110 kg, and patients weighing more than 110 kg but less than 120 kg; (S-2) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody (T-2) 900 mg is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg. use.

[15] (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 120 kg or more and less than 140 kg; (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 140 kg or more and less than 165 kg; (I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 140 kg or more and less than 165 kg. Any one of the pharmaceutical compositions, methods, or uses of [7-1], [9-1], [10-1], [11-1], [13-1], and [14-1]. [15-1](A) 135 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 120 kg or more and less than 140 kg; (H) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 140 kg or more and less than 165 kg; (I) 135 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 140 kg or more and less than 165 kg. A bispecific antibody of type [8-1] or [12-1].

[16] The patient was administered a bispecific antibody at a loading dose of 3 mg / kg four times at one-week intervals (once a week for four weeks); and After completing the administration of the loading dose, from the fifth dose onward, a bispecific antibody, such as a bispecific antibody contained in a pharmaceutical composition, is administered to the patient every two weeks at a maintenance dose selected from the group consisting of (a)~(h), (a-1)~(g-1), (a-2)~(h-2), (C1)~(C8), (A)~(H), (A-1)~(G-1), and (A-2)~(H-2), or a bispecific antibody, such as a bispecific antibody contained in a pharmaceutical composition, is administered to the patient every four weeks at a maintenance dose selected from the group consisting of (i)~(t), (h-1)~(r-1), (i-2)~(t-2), (C9)~(C20), (I)~(T), (H-1)~(R-1), and (I-2)~(T-2). (a) to (h) are defined in [1], [2], [3], [4], or [5]; (a-1)~(g-1) are defined in [1-1], [2-1], [3-1], [4-1], or [5-1]; (a-2)~(h-2) are defined in [1-2], [2-2], [3-2], [4-2], or [5-2]; (C1) to (C8) are defined in [6]; (A) to (H) are defined in [7], [7-1], [8], [8-1], [9], [9-1],

[10] , [10-1],

[15] , or [15-1]; (A-1) to (G-1) are defined in [7-2], [8-2], [9-2], or [10-2]; (A-2) to (H-2) are defined in [7-3], [8-3], [9-3], or [10-3]; (i)~(t) are defined in [1], [2], [3], [4], or [5]; (h-1)~(r-1) is defined in [1-1], [2-1], [3-1], [4-1], or [5-1]; (i-2)~(t-2) is defined in [1-2], [2-2], [3-2], [4-2], or [5-2]; (C9)~(C20) are defined in [6]; (I)~(T) are defined in

[11] , [11-1],

[12] , [12-1],

[13] , [13-1],

[14] , [14-1],

[15] , or [15-1]; (H-1)~(R-1) are defined in [11-2], [12-2], [13-2], or [14-2]; (I-2)~(T-2) are defined in [11-3], [12-3], [13-3], or [14-3]. Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, or kits listed in [1] to [15-1]. [16-1] A maintenance dose of a bispecific antibody, for example, a maintenance dose of a bispecific antibody contained in a pharmaceutical composition, is administered to the patient one week after the last dose of the loading dose.

[16] Pharmaceutical compositions, bispecific antibodies, methods, uses, or kits.

[17] The patient was administered a bispecific antibody at a loading dose of 3 mg / kg four times at one-week intervals (once a week for four weeks); and After completing the administration of the loading dose, the bispecific antibody is administered to the patient once or multiple times separately at a maintenance dose of 6 mg / kg per 4 weeks; and then, A bispecific antibody, such as one contained in a pharmaceutical composition, is administered to the patient every two weeks at a maintenance dose selected from the group consisting of (a)~(h), (a-1)~(g-1), (a-2)~(h-2), (C1)~(C8), (A)~(H), (A-1)~(G-1), and (A-2)~(H-2), or a bispecific antibody, such as one contained in a pharmaceutical composition, is administered to the patient every four weeks at a maintenance dose selected from the group consisting of (i)~(t), (h-1)~(r-1), (i-2)~(t-2), (C9)~(C20), (I)~(T), (H-1)~(R-1), and (I-2)~(T-2). (a) to (h) are defined in [1], [2], [3], [4], or [5]; (a-1)~(g-1) are defined in [1-1], [2-1], [3-1], [4-1], or [5-1]; (a-2)~(h-2) are defined in [1-2], [2-2], [3-2], [4-2], or [5-2]; (C1) to (C8) are defined in [6]; (A) to (H) are defined in [7], [7-1], [8], [8-1], [9], [9-1],

[10] , [10-1],

[15] , or [15-1]; (A-1) to (G-1) are defined in [7-2], [8-2], [9-2], or [10-2]; (A-2) to (H-2) are defined in [7-3], [8-3], [9-3], or [10-3]; (i)~(t) are defined in [1], [2], [3], [4], or [5]; (h-1)~(r-1) is defined in [1-1], [2-1], [3-1], [4-1], or [5-1]; (i-2)~(t-2) is defined in [1-2], [2-2], [3-2], [4-2], or [5-2]; (C9)~(C20) are defined in [6]; (I)~(T) are defined in

[11] , [11-1],

[12] , [12-1],

[13] , [13-1],

[14] , [14-1],

[15] , or [15-1]; (H-1)~(R-1) are defined in [11-2], [12-2], [13-2], or [14-2]; (I-2)~(T-2) are defined in [11-3], [12-3], [13-3], or [14-3]. Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, or kits listed in [1] to [15-1]. To clarify, when referring to a bispecific antibody administered to a patient "at a maintenance dose of 6 mg / kg per 4 weeks, either once or multiple times separately," the amount of bispecific antibody in each maintenance dose will total 6 mg / kg over a 4-week period, and each maintenance dose is intended to be given either as a single dose once every 4-week period or evenly divided into two or more doses spaced evenly apart over each 4-week period. For example, each 6 mg / kg maintenance dose may be (i) administered once every 4 weeks, or (ii) divided into two every-other-week doses of 3 mg / kg each, or (iii) divided into four weekly doses of 1.5 mg / kg each. [17-1] The patient was administered a bispecific antibody at a loading dose of 3 mg / kg four times at one-week intervals (once a week for four weeks); and After the loading dose has been administered, one or more maintenance doses of bispecific antibodies are then administered to the patient, with the amount of antibody in each maintenance dose totaling 6 mg / kg over a period of 4 weeks, and each maintenance dose is administered once every 4 weeks or divided into two or more doses spaced apart over each 4-week period, and then A bispecific antibody, such as one contained in a pharmaceutical composition, is administered to the patient every two weeks at a maintenance dose selected from the group consisting of (a)~(h), (a-1)~(g-1), (a-2)~(h-2), (C1)~(C8), (A)~(H), (A-1)~(G-1), and (A-2)~(H-2), or a bispecific antibody, such as one contained in a pharmaceutical composition, is administered to the patient every four weeks at a maintenance dose selected from the group consisting of (i)~(t), (h-1)~(r-1), (i-2)~(t-2), (C9)~(C20), (I)~(T), (H-1)~(R-1), and (I-2)~(T-2). (a) to (h) are defined in [1], [2], [3], [4], or [5]; (a-1)~(g-1) are defined in [1-1], [2-1], [3-1], [4-1], or [5-1]; (a-2)~(h-2) are defined in [1-2], [2-2], [3-2], [4-2], or [5-2]; (C1) to (C8) are defined in [6]; (A) to (H) are defined in [7], [7-1], [8], [8-1], [9], [9-1],

[10] , [10-1],

[15] , or [15-1]; (A-1) to (G-1) are defined in [7-2], [8-2], [9-2], or [10-2]; (A-2) to (H-2) are defined in [7-3], [8-3], [9-3], or [10-3]; (i)~(t) are defined in [1], [2], [3], [4], or [5]; (h-1)~(r-1) is defined in [1-1], [2-1], [3-1], [4-1], or [5-1]; (i-2)~(t-2) is defined in [1-2], [2-2], [3-2], [4-2], or [5-2]; (C9)~(C20) are defined in [6]; (I)~(T) are defined in

[11] , [11-1],

[12] , [12-1],

[13] , [13-1],

[14] , [14-1],

[15] , or [15-1]; (H-1)~(R-1) are defined in [11-2], [12-2], [13-2], or [14-2]; (I-2)~(T-2) are defined in [11-3], [12-3], [13-3], or [14-3]. Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, or kits listed in [1] to [15-1]. [17-2] Administration of a maintenance dose of a bispecific antibody at 6 mg / kg per 4 weeks is selected from the following groups (m1) to (m3): Pharmacopoeia, bispecific antibody, method, use, or kit of

[17] or [17-1]: (m1) The maintenance dose is 6 mg / kg, administered as a single dose of the bispecific antibody, where the 6 mg / kg maintenance dose of the bispecific antibody is administered once every 4 weeks. (m2) The maintenance dose is administered twice at a single dose of the bispecific antibody at 3 mg / kg each, where each single dose of the 3 mg / kg bispecific antibody maintenance dose is administered once every two weeks, or (m3) The maintenance dose is 1.5 mg / kg each, administered in four doses equivalent to one dose of the bispecific antibody, where each dose of the 1.5 mg / kg bispecific antibody maintenance dose is administered once a week. [17-3] The first maintenance dose of a bispecific antibody selected from the group consisting of (m1) to (m3) is administered one week after the last dose of the loading dose. Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, or kits described in [17-2]. [17-4] A pharmaceutical composition containing a bispecific antibody administered at a loading dose of 3 mg / kg, one of the pharmaceutical compositions, bispecific antibody, method, use, or kit described in

[16] ,

[17] , and [17-1], which is contained in a vial.

[18] A single dose of a bispecific antibody selected from the group consisting of (aa) to (hh) contained in the pharmaceutical composition is administered to the patient (subject) once a week for four weeks; Thereafter, a maintenance dose of a bispecific antibody selected from the group consisting of (a) to (h) as defined in [1], [2], [3], or [4], contained in the pharmaceutical composition, is administered to the patient (subject) every two weeks as a single dose; (aa)~(hh) and (a)~(h) are as follows: Any one of the pharmaceutical compositions, bispecific antibodies, methods, or uses described in [1], [2], [3], and [4]: (aa) For patients (subjects) weighing 41 kg or more but less than 50 kg, a loading dose of 135 mg; (bb) For patients (subjects) weighing 50 kg or more but less than 60 kg, a loading dose of 165 mg; (cc) A loading dose of 195 mg for patients (subjects) weighing 60 kg or more but less than 70 kg; (dd) For patients (subjects) weighing 70 kg or more but less than 83 kg, a loading dose of 225 mg; (ee) For patients (subjects) weighing 83 kg or more but less than 100 kg, a loading dose of 270 mg; (ff) A loading dose of 330 mg for patients (subjects) weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients (subjects) weighing 120 kg or more and less than 140 kg; (hh) For patients (subjects) weighing 140 kg or more and less than 165 kg, a loading dose of 450 mg; (a) A maintenance dose of 135 mg for patients (subjects) weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients (subjects) weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients (subjects) weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients (subjects) weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients (subjects) weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients (subjects) weighing 120 kg or more but less than 140 kg; (h) A maintenance dose of 450 mg for patients (subjects) weighing 140 kg or more and less than 165 kg. [18-1] A single dose of a bispecific antibody selected from the group consisting of (aa-1) to (gg-1) contained in the pharmaceutical composition is administered to the patient (subject) once a week for four weeks; Thereafter, a maintenance dose of a bispecific antibody selected from the group consisting of (a-1) to (g-1) as defined in [1-1], [2-1], [3-1], or [4-1], contained in the pharmaceutical composition, is administered to the patient (subject) every two weeks as a single dose; (aa-1)~(gg-1) and (a-1)~(g-1) are as follows: Any one of the pharmaceutical compositions, bispecific antibodies, methods, or uses described in [1-1], [2-1], [3-1], and [4-1]: (aa-1) For patients (subjects) weighing 48 kg or more but less than 50 kg, a loading dose of 135 mg; (bb-1) For patients (subjects) weighing 66 kg or more but less than 70 kg, a loading dose of 195 mg; (cc-1) For patients (subjects) weighing 76 kg or more but less than 83 kg, a loading dose of 225 mg; (dd-1) A loading dose of 270 mg for patients (subjects) weighing 99 kg or more but less than 100 kg; (ee-1) A loading dose of 330 mg for patients (subjects) weighing 111 kg or more and less than 120 kg; (ff-1) A loading dose of 390 mg for patients (subjects) weighing 131 kg or more and less than 140 kg; (gg-1) For patients (subjects) weighing 151 kg or more and less than 165 kg, a loading dose of 450 mg; (a-1) For patients (subjects) weighing 48 kg or more but less than 50 kg, a maintenance dose of 135 mg; (b-1) For patients (subjects) weighing 66 kg or more but less than 70 kg, a maintenance dose of 195 mg; (c-1) For patients (subjects) weighing 76 kg or more but less than 83 kg, a maintenance dose of 225 mg; (d-1) For patients (subjects) weighing 99 kg or more but less than 100 kg, a maintenance dose of 270 mg; (e-1) For patients (subjects) weighing 111 kg or more but less than 120 kg, a maintenance dose of 330 mg; (f-1) For patients (subjects) weighing 131 kg or more but less than 140 kg, a maintenance dose of 390 mg; (g-1) A maintenance dose of 450 mg for patients (subjects) weighing 151 kg or more and less than 165 kg. [18-2] A single dose of a bispecific antibody selected from the group consisting of (aa-2) to (hh-2) contained in the pharmaceutical composition is administered to the patient (subject) once a week for four weeks; Thereafter, a maintenance dose of a bispecific antibody selected from the group consisting of (a-2) to (h-2) as defined in [1-2], [2-2], [3-2], or [4-2], contained in the pharmaceutical composition, is administered to the patient (subject) every two weeks as a single dose; (aa-2)~(hh-2) and (a-2)~(h-2) are as follows: Any one of the pharmaceutical compositions, bispecific antibodies, methods, or uses described in [1-2], [2-2], [3-2], and [4-2]: (aa-2) For patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, a loading dose of 135 mg; (bb-2) For patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a loading dose of 165 mg; (cc-2) For patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a loading dose of 195 mg; (dd-2) For patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a loading dose of 225 mg; (ee-2) For patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a loading dose of 270 mg; (ff-2) For patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a loading dose of 330 mg; (gg-2) For patients (subjects) weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a loading dose of 390 mg; (hh-2) For patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a loading dose of 450 mg; (a-2) For patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, a maintenance dose of 135 mg; (b-2) For patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 165 mg; (c-2) For patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 195 mg; (d-2) For patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a maintenance dose of 225 mg; (e-2) For patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a maintenance dose of 270 mg; (f-2) For patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 330 mg; (g-2) For patients (subjects) weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a maintenance dose of 390 mg; (h-2) A maintenance dose of 450 mg for patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [18-3] A single dose of a bispecific antibody selected from the group consisting of (aa) to (hh) contained in the pharmaceutical composition is administered to the patient (subject) once a week for four weeks; Thereafter, a maintenance dose of a bispecific antibody selected from the group consisting of (m) to (t) as defined in [1], [2], [3], or [4] is administered to the patient (subject) every four weeks; (aa)~(hh) and (m)~(t) are as follows: Any one of the pharmaceutical compositions, bispecific antibodies, methods, or uses described in [1], [2], [3], and [4]: (aa) For patients (subjects) weighing 41 kg or more but less than 50 kg, a loading dose of 135 mg; (bb) For patients (subjects) weighing 50 kg or more but less than 60 kg, a loading dose of 165 mg; (cc) A loading dose of 195 mg for patients (subjects) weighing 60 kg or more but less than 70 kg; (dd) For patients (subjects) weighing 70 kg or more but less than 83 kg, a loading dose of 225 mg; (ee) For patients (subjects) weighing 83 kg or more but less than 100 kg, a loading dose of 270 mg; (ff) A loading dose of 330 mg for patients (subjects) weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients (subjects) weighing 120 kg or more and less than 140 kg; (hh) For patients (subjects) weighing 140 kg or more and less than 165 kg, a loading dose of 450 mg; (m) For patients (subjects) weighing 41 kg or more but less than 50 kg, a maintenance dose of 270 mg; (n) A maintenance dose of 330 mg for patients (subjects) weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients (subjects) weighing 60 kg or more but less than 70 kg; (p) For patients (subjects) weighing 70 kg or more but less than 83 kg, a maintenance dose of 450 mg; (q) For patients (subjects) weighing 83 kg or more but less than 100 kg, a maintenance dose of 540 mg; (r) A maintenance dose of 660 mg for patients (subjects) weighing 100 kg or more but less than 120 kg; (s) For patients weighing 120 kg or more and less than 140 kg (subjects), a maintenance dose of 780 mg; (t) A maintenance dose of 900 mg for patients (subjects) weighing 140 kg or more and less than 165 kg. [18-4] A single dose of a bispecific antibody selected from the group consisting of (aa-1) to (gg-1) contained in the pharmaceutical composition is administered to the patient (subject) once a week for four weeks; Thereafter, a maintenance dose of a bispecific antibody selected from the group consisting of (l-1) to (r-1) as defined in [1-1], [2-1], [3-1], or [4-1] is administered to the patient (subject) every four weeks; (aa-1)~(gg-1) and (l-1)~(r-1) are as follows: Any one of the pharmaceutical compositions, bispecific antibodies, methods, or uses described in [1-1], [2-1], [3-1], and [4-1]: (aa-1) For patients (subjects) weighing 48 kg or more but less than 50 kg, a loading dose of 135 mg; (bb-1) For patients (subjects) weighing 66 kg or more but less than 70 kg, a loading dose of 195 mg; (cc-1) For patients (subjects) weighing 76 kg or more but less than 83 kg, a loading dose of 225 mg; (dd-1) A loading dose of 270 mg for patients (subjects) weighing 99 kg or more but less than 100 kg; (ee-1) A loading dose of 330 mg for patients (subjects) weighing 111 kg or more and less than 120 kg; (ff-1) A loading dose of 390 mg for patients (subjects) weighing 131 kg or more and less than 140 kg; (gg-1) For patients (subjects) weighing 151 kg or more and less than 165 kg, a loading dose of 450 mg; (l-1) For patients (subjects) weighing 48 kg or more but less than 50 kg, a maintenance dose of 270 mg; (m-1) For patients (subjects) weighing 66 kg or more but less than 70 kg, a maintenance dose of 390 mg; (n-1) For patients (subjects) weighing 76 kg or more but less than 83 kg, a maintenance dose of 450 mg; (o-1) For patients (subjects) weighing 99 kg or more but less than 100 kg, a maintenance dose of 540 mg; (p-1) For patients (subjects) weighing 111 kg or more but less than 120 kg, a maintenance dose of 660 mg; (q-1) For patients (subjects) weighing 131 kg or more and less than 140 kg, a maintenance dose of 780 mg; and (r-1) For patients (subjects) weighing 151 kg or more and less than 165 kg, a maintenance dose of 900 mg. [18-5] A single dose of a bispecific antibody selected from the group consisting of (aa-2) to (hh-2) contained in the pharmaceutical composition is administered to the patient (subject) once a week for four weeks; Subsequently, a maintenance dose of a bispecific antibody selected from the group consisting of (m-2) to (t-2) as defined in [1-2], [2-2], [3-2], or [4-2] is administered to the patient (subject) every four weeks; (aa-2)~(hh-2) and (m-2)~(t-2) are as follows: Any one of the pharmaceutical compositions, bispecific antibodies, methods, or uses described in [1-2], [2-2], [3-2], and [4-2]: (aa-2) For patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, a loading dose of 135 mg; (bb-2) For patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a loading dose of 165 mg; (cc-2) For patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a loading dose of 195 mg; (dd-2) For patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a loading dose of 225 mg; (ee-2) For patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a loading dose of 270 mg; (ff-2) For patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a loading dose of 330 mg; (gg-2) For patients (subjects) weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a loading dose of 390 mg; (hh-2) For patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a loading dose of 450 mg; (m-2) For patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 270 mg; (n-2) For patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 330 mg; (o-2) For patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 390 mg; (p-2) For patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a maintenance dose of 450 mg; (q-2) For patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a maintenance dose of 540 mg; (r-2) For patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 660 mg; (s-2) For patients (subjects) weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg, a maintenance dose of 780 mg; and (t-2) A maintenance dose of 900 mg for patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [18-6] The above instruction document, The bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa) to (hh); Subsequently, a maintenance dose of a bispecific antibody selected from the group consisting of (a) to (h) as defined in [5] is administered to the patient every two weeks. Further instructions were given to: (aa)~(hh) and (a)~(h) are as follows: [5] kit: (aa) For patients weighing 41 kg or more but less than 50 kg, a loading dose of 135 mg; (bb) For patients weighing 50 kg or more but less than 60 kg, a loading dose of 165 mg; (cc) A loading dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (dd) For patients weighing 70 kg or more and less than 83 kg, a loading dose of 225 mg; (ee) A loading dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (ff) A loading dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (hh) For patients weighing 140 kg or more and less than 165 kg, a loading dose of 450 mg; (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) A maintenance dose of 450 mg for patients weighing 140 kg or more and less than 165 kg. [18-7] The above instruction document, The aforementioned bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa-1) to (gg-1); Subsequently, a maintenance dose of a bispecific antibody selected from the group consisting of (a-1) to (g-1) as defined in [5] is administered to the patient every two weeks. Further instructions were given to: (aa-1)~(gg-1) and (a-1)~(g-1) are as follows: Kit [5-1]: (aa-1) For patients weighing 48 kg or more but less than 50 kg, a loading dose of 135 mg; (bb-1) For patients weighing 66 kg or more but less than 70 kg, a loading dose of 195 mg; (cc-1) For patients weighing 76 kg or more and less than 83 kg, a loading dose of 225 mg; (dd-1) A loading dose of 270 mg for patients weighing 99 kg or more but less than 100 kg; (ee-1) A loading dose of 330 mg for patients weighing 111 kg or more but less than 120 kg; (ff-1) A loading dose of 390 mg for patients weighing 131 kg or more and less than 140 kg; (gg-1) A loading dose of 450 mg for patients weighing 151 kg or more and less than 165 kg; (a-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 135 mg; (b-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 195 mg; (c-1) For patients weighing 76 kg or more and less than 83 kg, a maintenance dose of 225 mg; (d-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 270 mg; (e-1) A maintenance dose of 330 mg for patients weighing 111 kg or more but less than 120 kg; (f-1) For patients weighing 131 kg or more but less than 140 kg, a maintenance dose of 390 mg; (g-1) A maintenance dose of 450 mg for patients weighing 151 kg or more and less than 165 kg. [18-8] The above instruction document, The aforementioned bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa-2) to (hh-2); Subsequently, a maintenance dose of a bispecific antibody selected from the group consisting of (a-2) to (h-2) as defined in [5-2] is administered to the patient every two weeks. Further instructions were given to: (aa-2)~(hh-2) and (a-2)~(h-2) are as follows: Kit [5-2]: (aa-2) For patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, a loading dose of 135 mg; (bb-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a loading dose of 165 mg; (cc-2) A loading dose of 195 mg for patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (dd-2) A loading dose of 225 mg for patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (ee-2) For patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a loading dose of 270 mg; (ff-2) A loading dose of 330 mg for patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (gg-2) A loading dose of 390 mg for patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; (hh-2) For patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a loading dose of 450 mg; (a-2) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 45 kg, and for patients weighing more than 45 kg but less than 50 kg; (b-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 165 mg; (c-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 195 mg; (d-2) For patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg, a maintenance dose of 225 mg; (e-2) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (f-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 330 mg; (g-2) For patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg, a maintenance dose of 390 mg; (h-2) A maintenance dose of 450 mg for patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [18-9] The above instruction document, The bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa) to (hh); Subsequently, a maintenance dose of a bispecific antibody selected from the group consisting of (m) to (t) as defined in [5] is administered to the patient every four weeks. Further instructions were given to: (aa)~(hh) and (m)~(t) are as follows: [5] kit: (aa) For patients weighing 41 kg or more but less than 50 kg, a loading dose of 135 mg; (bb) For patients weighing 50 kg or more but less than 60 kg, a loading dose of 165 mg; (cc) A loading dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (dd) For patients weighing 70 kg or more and less than 83 kg, a loading dose of 225 mg; (ee) A loading dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (ff) A loading dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (hh) For patients weighing 140 kg or more and less than 165 kg, a loading dose of 450 mg; (m) For patients weighing 41 kg or more and less than 50 kg, a maintenance dose of 270 mg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more and less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) For patients weighing 120 kg or more and less than 140 kg, a maintenance dose of 780 mg; (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg. [18-10] The above instruction document, The aforementioned bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa-1) to (gg-1); Subsequently, a maintenance dose of a bispecific antibody selected from the group consisting of (l-1) to (r-1) as defined in [5-1] is administered to the patient every four weeks. Further instructions were given to: (aa-1)~(gg-1) and (l-1)~(r-1) are as follows: Kit [5-1]: (aa-1) For patients weighing 48 kg or more but less than 50 kg, a loading dose of 135 mg; (bb-1) For patients weighing 66 kg or more but less than 70 kg, a loading dose of 195 mg; (cc-1) For patients weighing 76 kg or more and less than 83 kg, a loading dose of 225 mg; (dd-1) A loading dose of 270 mg for patients weighing 99 kg or more but less than 100 kg; (ee-1) A loading dose of 330 mg for patients weighing 111 kg or more but less than 120 kg; (ff-1) A loading dose of 390 mg for patients weighing 131 kg or more and less than 140 kg; (gg-1) A loading dose of 450 mg for patients weighing 151 kg or more and less than 165 kg; (l-1) For patients weighing 48 kg or more but less than 50 kg, a maintenance dose of 270 mg; (m-1) For patients weighing 66 kg or more but less than 70 kg, a maintenance dose of 390 mg; (n-1) A maintenance dose of 450 mg for patients weighing 76 kg or more and less than 83 kg; (o-1) For patients weighing 99 kg or more but less than 100 kg, a maintenance dose of 540 mg; (p-1) For patients weighing 111 kg or more but less than 120 kg, a maintenance dose of 660 mg; (q-1) A maintenance dose of 780 mg for patients weighing 131 kg or more and less than 140 kg; and (r-1) A maintenance dose of 900 mg for patients weighing 151 kg or more and less than 165 kg. [18-11] The above instruction document, The aforementioned bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa-2) to (hh-2); Subsequently, a maintenance dose of a bispecific antibody selected from the group consisting of (m-2) to (t-2) as defined in [5-2] is administered to the patient every four weeks. Further instructions were given to: (aa-2)~(hh-2) and (m-2)~(t-2) are as follows: Kit [5-2]: (aa-2) For patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, a loading dose of 135 mg; (bb-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a loading dose of 165 mg; (cc-2) A loading dose of 195 mg for patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (dd-2) A loading dose of 225 mg for patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (ee-2) For patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a loading dose of 270 mg; (ff-2) A loading dose of 330 mg for patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (gg-2) A loading dose of 390 mg for patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; (hh-2) For patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg, a loading dose of 450 mg; (m-2) For patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg, the maintenance dose is 270 mg; (n-2) For patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg, a maintenance dose of 330 mg; (o-2) For patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg, a maintenance dose of 390 mg; (p-2) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (q-2) For patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg, a maintenance dose of 540 mg; (r-2) For patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg, a maintenance dose of 660 mg; (s-2) For patients weighing 120 kg or more but less than 130 kg, and more than 130 kg but less than 140 kg, a maintenance dose of 780 mg; and (t-2) A maintenance dose of 900 mg for patients weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. [18-12] A pharmaceutical composition of [6] selected from the group consisting of (CC1) to (CC8) below: (CC1) A pharmaceutical composition comprising a single dose of 135 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 41 kg or more and less than 50 kg, administered once weekly for four weeks, and thereafter once every two weeks to the same patients; (CC2) A pharmaceutical composition comprising a single dose of 165 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 50 kg or more and less than 60 kg, administered once weekly for four weeks, and thereafter once every two weeks to the same patients; (CC3) A pharmaceutical composition comprising a single dose of 195 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 60 kg or more and less than 70 kg, administered once weekly for four weeks, and thereafter once every two weeks to the same patients; (CC4) A pharmaceutical composition comprising a single dose of 225 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 70 kg or more and less than 83 kg, administered once weekly for four weeks, and thereafter once every two weeks to the same patients; (CC5) A pharmaceutical composition comprising a single dose of 270 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 83 kg or more and less than 100 kg, administered once weekly for four weeks, and thereafter once every two weeks to the same patients; (CC6) A pharmaceutical composition comprising a single dose of 330 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 100 kg or more and less than 120 kg, administered once weekly for four weeks, and thereafter once every two weeks to the same patients; (CC7) A pharmaceutical composition comprising a single dose of 390 mg of a bispecific antibody for use in patients with congenital hemophilia A weighing 120 kg or more and less than 140 kg, administered once weekly for four weeks, and thereafter once every two weeks to the same patients; (CC8) A pharmaceutical composition comprising a single dose of 450 mg of a bispecific antibody for use in patients with congenital hemophilia A weighing 140 kg or more and less than 165 kg, administered once weekly for four weeks, and thereafter administered once every two weeks to the same patients. [18-13](AA) 135 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 41 kg or more and less than 50 kg; (BB) 165 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 50 kg or more and less than 60 kg; (CC) 195 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 60 kg or more and less than 70 kg; (DD) 225 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 70 kg or more and less than 83 kg; (EE) 270 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 83 kg or more and less than 100 kg; (FF) 330 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 100 kg or more and less than 120 kg; (GG) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 120 kg or more and less than 140 kg; and / or A bispecific antibody of (HH) 450 mg was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 140 kg or more and less than 165 kg; And then, (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 120 kg or more and less than 140 kg; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient (subject) weighing 140 kg or more and less than 165 kg. A pharmaceutical composition or method according to either [7] or [9]. [18-14](AA-1) 135 mg of bispecific antibody is administered as a single loading dose once a week for 4 weeks to subjects weighing 48 kg or more and less than 50 kg; (BB-1) 195 mg of bispecific antibody is administered as a single loading dose once a week for 4 weeks to subjects weighing 66 kg or more and less than 70 kg; (CC-1) 225 mg of bispecific antibody is administered as a single loading dose once a week for 4 weeks to subjects weighing 76 kg or more and less than 83 kg; (DD-1) 270 mg of bispecific antibody is administered as a single loading dose once a week for 4 weeks to subjects weighing 99 kg or more and less than 100 kg; (EE-1) 330 mg of bispecific antibody is administered as a single loading dose once a week for 4 weeks to subjects weighing 111 kg or more and less than 120 kg; (FF-1) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to subjects weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (GG-1) 450 mg is administered as a single loading dose once a week for four weeks to subjects weighing 151 kg or more and less than 165 kg; And then, (A-1) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 48 kg or more and less than 50 kg; (B-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 66 kg or more and less than 70 kg; (C-1) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 76 kg or more and less than 83 kg; (D-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 99 kg or more and less than 100 kg; (E-1) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 111 kg or more and less than 120 kg; (F-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 131 kg or more and less than 140 kg; and / or (G-1) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to subjects weighing 151 kg or more and less than 165 kg. A pharmaceutical composition or method according to either [7-2] or [9-2]. [18-15](AA-2) 135 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (BB-2) 165 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; A bispecific antibody (CC-2) 195 mg was administered as a single loading dose once weekly for four weeks to patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (DD-2) 225 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; A bispecific antibody of (EE-2) 270 mg was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; A 330 mg dose of bispecific antibody (FF-2) was administered as a single loading dose once weekly for four weeks to patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (GG-2) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (HH-2) 450 mg was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg; And then, (A-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (B-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (C-2) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (D-2) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (E-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (F-2) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (G-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (H-2) 450 mg is administered as a single maintenance dose once every two weeks to patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. A pharmaceutical composition or method according to either [7-3] or [9-3]. [18-16](AA) 135 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 41 kg or more and less than 50 kg; (BB) 165 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 50 kg or more and less than 60 kg; (CC) 195 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 60 kg or more and less than 70 kg; (DD) 225 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 70 kg or more and less than 83 kg; (EE) 270 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 83 kg or more and less than 100 kg; (FF) 330 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 100 kg or more and less than 120 kg; (GG) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 120 kg or more and less than 140 kg; and / or A bispecific antibody of (HH) 450 mg was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 140 kg or more and less than 165 kg; And then, (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 120 kg or more and less than 140 kg; (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 140 kg or more and less than 165 kg. A pharmaceutical composition or method according to either

[11] or

[13] . [18-17](AA-1) 135 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 48 kg or more and less than 50 kg; A bispecific antibody of (BB-1) 195 mg was administered as a single loading dose once a week for 4 weeks to patients (subjects) weighing 66 kg or more and less than 70 kg; (CC-1) 225 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 76 kg or more and less than 83 kg; (DD-1) 270 mg of bispecific antibody was administered as a single loading dose once a week for 4 weeks to patients (subjects) weighing 99 kg or more and less than 100 kg; A bispecific antibody of (EE-1) 330 mg was administered as a single loading dose once a week for 4 weeks to patients (subjects) weighing 111 kg or more and less than 120 kg; (FF-1) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody of (GG-1) 450 mg was administered as a single loading dose once a week for four weeks to patients (subjects) weighing 151 kg or more and less than 165 kg; And then, (L-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 48 kg or more and less than 50 kg; (M-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 66 kg or more and less than 70 kg; A bispecific antibody (N-1) 450 mg is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 76 kg or more and less than 83 kg; (O-1) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 99 kg or more and less than 100 kg; (P-1) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 111 kg or more and less than 120 kg; (Q-1) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (R-1) 900 mg is administered as a single maintenance dose once every four weeks to the patient (subject) weighing 151 kg or more and less than 165 kg. A pharmaceutical composition or method according to either [11-2] or [13-2]. [18-18](AA-2) 135 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (BB-2) 165 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; A bispecific antibody (CC-2) 195 mg was administered as a single loading dose once weekly for four weeks to patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (DD-2) 225 mg of bispecific antibody was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; A bispecific antibody of (EE-2) 270 mg was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; A 330 mg dose of bispecific antibody (FF-2) was administered as a single loading dose once weekly for four weeks to patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (GG-2) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (HH-2) 450 mg was administered as a single loading dose once weekly for 4 weeks to patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg; And then, (M-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; A bispecific antibody (N-2)330 mg is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (O-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (P-2) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (Q-2) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; A bispecific antibody (R-2) 660 mg is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (S-2) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody (T-2) 900 mg is administered as a single maintenance dose once every four weeks to patients (subjects) weighing 140 kg or more but less than 150 kg, and greater than 150 kg but less than 165 kg. A pharmaceutical composition or method according to either [11-3] or [13-3]. [18-19](AA) 135 mg of bispecific antibody is administered weekly for 4 weeks to patients weighing 41 kg or more and less than 50 kg as a single loading dose in the pharmaceutical composition; (BB) 165 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg, once weekly for 4 weeks; (CC) 195 mg of bispecific antibody is administered weekly for 4 weeks to patients weighing 60 kg or more and less than 70 kg as a single loading dose in the pharmaceutical composition; (DD) 225 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg, once weekly for 4 weeks; (EE) 270 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg, once weekly for 4 weeks; (FF) 330 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 100 kg or more and less than 120 kg, once weekly for 4 weeks; (GG) 390 mg of bispecific antibody is administered weekly for 4 weeks to patients weighing 120 kg or more and less than 140 kg as a single loading dose in the pharmaceutical composition; and / or (HH) 450 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 140 kg or more and less than 165 kg, once weekly for 4 weeks; And then, (A) 135 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg, once every two weeks; (B) 165 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg, once every two weeks; (C) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more and less than 70 kg, once every two weeks; (D) 225 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg, once every two weeks; (E) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg, once every two weeks; (F) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 100 kg or more and less than 120 kg, once every two weeks; (G) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more and less than 140 kg, once every two weeks; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 140 kg or more and less than 165 kg, once every two weeks. [8] A bispecific antibody. [18-20](AA-1) 135 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 48 kg or more and less than 50 kg, once weekly for 4 weeks; (BB-1) 195 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 66 kg or more and less than 70 kg, once weekly for 4 weeks; (CC-1) 225 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 76 kg or more and less than 83 kg, once weekly for 4 weeks; (DD-1) 270 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 99 kg or more and less than 100 kg, once weekly for 4 weeks; (EE-1) 330 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 111 kg or more and less than 120 kg, once weekly for 4 weeks; (FF-1) 390 mg of bispecific antibody is administered weekly for 4 weeks to patients weighing 131 kg or more and less than 140 kg as a single loading dose in the pharmaceutical composition; and / or (GG-1) 450 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 151 kg or more and less than 165 kg, once weekly for 4 weeks; And then, (A-1) 135 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 48 kg or more and less than 50 kg, once every two weeks; (B-1) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 66 kg or more and less than 70 kg, once every two weeks; (C-1) 225 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 76 kg or more and less than 83 kg, once every two weeks; (D-1) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 99 kg or more and less than 100 kg, once every two weeks; (E-1) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 111 kg or more and less than 120 kg, once every two weeks; (F-1) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 131 kg or more and less than 140 kg, once every two weeks; and / or (G-1) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 151 kg or more and less than 165 kg, once every two weeks. [8-2] Bispecific antibody. [18-21](AA-2) 135 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg, once weekly for 4 weeks; (BB-2) 165 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg, once weekly for four weeks; (CC-2) 195 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg, once weekly for four weeks; (DD-2) 225 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg, once weekly for four weeks; (EE-2) 270 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 83 kg or more but less than 90 kg, and patients weighing more than 90 kg but less than 100 kg, once weekly for four weeks; (FF-2) 330 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 100 kg or more but less than 110 kg, and to patients weighing more than 110 kg but less than 120 kg, once weekly for four weeks; (GG-2) 390 mg of bispecific antibody is administered weekly for 4 weeks as a single loading dose in the pharmaceutical composition to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (HH-2) 450 mg is administered weekly for 4 weeks as a single loading dose in the pharmaceutical composition to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg; And then, (A-2) 135 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (B-2) 165 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more but less than 55 kg, and to patients weighing more than 55 kg but less than 60 kg, once every two weeks; (C-2) 195 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more but less than 65 kg, and to patients weighing more than 65 kg but less than 70 kg, once every two weeks; (D-2) 225 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (E-2) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 83 kg or more but less than 90 kg, and to patients weighing more than 90 kg but less than 100 kg, once every two weeks; (F-2) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 100 kg or more but less than 110 kg, and to patients weighing more than 110 kg but less than 120 kg, once every two weeks; (G-2) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more but less than 130 kg, and to patients weighing more than 130 kg but less than 140 kg, once every two weeks; and / or A bispecific antibody of (H-2) 450 mg is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 140 kg or more but less than 150 kg, and to patients weighing more than 150 kg but less than 165 kg, once every two weeks. [8-3] Bispecific antibody. [18-22](AA) 135 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg, once weekly for 4 weeks; (BB) 165 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg, once weekly for 4 weeks; (CC) 195 mg of bispecific antibody is administered weekly for 4 weeks to patients weighing 60 kg or more and less than 70 kg as a single loading dose in the pharmaceutical composition; (DD) 225 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg, once weekly for 4 weeks; (EE) 270 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg, once weekly for 4 weeks; (FF) 330 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 100 kg or more and less than 120 kg, once weekly for 4 weeks; (GG) 390 mg of bispecific antibody is administered weekly for 4 weeks to patients weighing 120 kg or more and less than 140 kg as a single loading dose in the pharmaceutical composition; and / or (HH) 450 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 140 kg or more and less than 165 kg, once weekly for 4 weeks; And then, (M) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg, once every four weeks; (N) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg, once every four weeks; (O) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more and less than 70 kg, once every four weeks; (P) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg, once every four weeks; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg, once every four weeks; (R) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 100 kg or more and less than 120 kg, once every four weeks; (S) 780 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more and less than 140 kg, once every four weeks; and / or (T) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 140 kg or more and less than 165 kg, once every four weeks.

[12] A bispecific antibody. [18-23](AA-1) 135 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 48 kg or more and less than 50 kg, once weekly for 4 weeks; (BB-1) 195 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 66 kg or more and less than 70 kg, once weekly for 4 weeks; (CC-1) 225 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 76 kg or more and less than 83 kg, once weekly for 4 weeks; (DD-1) 270 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 99 kg or more and less than 100 kg, once weekly for 4 weeks; (EE-1) 330 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 111 kg or more and less than 120 kg, once weekly for 4 weeks; (FF-1) 390 mg of bispecific antibody is administered weekly for 4 weeks to patients weighing 131 kg or more and less than 140 kg as a single loading dose in the pharmaceutical composition; and / or (GG-1) 450 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 151 kg or more and less than 165 kg, once weekly for 4 weeks; And then, (L-1) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 48 kg or more and less than 50 kg, once every four weeks; (M-1) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 66 kg or more and less than 70 kg, once every four weeks; (N-1) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 76 kg or more and less than 83 kg, once every four weeks; (O-1) 540 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 99 kg or more and less than 100 kg, once every four weeks; (P-1) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 111 kg or more and less than 120 kg, once every four weeks; (Q-1) 780 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 131 kg or more and less than 140 kg, once every four weeks; and / or (R-1) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 151 kg or more and less than 165 kg, once every four weeks. [12-2] Bispecific antibody. [18-24](AA-2) 135 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg, once weekly for 4 weeks; (BB-2) 165 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg, once weekly for four weeks; (CC-2) 195 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg, once weekly for four weeks; (DD-2) 225 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg, once weekly for four weeks; (EE-2) 270 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 83 kg or more but less than 90 kg, and patients weighing more than 90 kg but less than 100 kg, once weekly for four weeks; (FF-2) 330 mg of bispecific antibody is administered as a single loading dose in the pharmaceutical composition to patients weighing 100 kg or more but less than 110 kg, and to patients weighing more than 110 kg but less than 120 kg, once weekly for four weeks; (GG-2) 390 mg of bispecific antibody is administered weekly for 4 weeks as a single loading dose in the pharmaceutical composition to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (HH-2) 450 mg is administered weekly for 4 weeks as a single loading dose in the pharmaceutical composition to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg; And then, (M-2) 270 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (N-2)330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (O-2)390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (P-2) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (Q-2) 540 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (R-2) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 100 kg or more but less than 110 kg, and to patients weighing more than 110 kg but less than 120 kg, once every four weeks; (S-2) 780 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or (T-2)900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition to patients weighing 140 kg or more but less than 150 kg, and to patients weighing more than 150 kg but less than 165 kg, once every four weeks. [12-3] Bispecific antibody. [18-25](AA) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 41 kg or more and less than 50 kg; (BB) 165 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 50 kg or more and less than 60 kg; (CC) 195 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 60 kg or more and less than 70 kg; (DD) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 70 kg or more and less than 83 kg; (EE) 270 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 83 kg or more and less than 100 kg; (FF) 330 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 100 kg or more and less than 120 kg; (GG) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 120 kg or more and less than 140 kg; and / or A bispecific antibody of (HH) 450 mg is administered as a single loading dose once weekly for 4 weeks to patients weighing 140 kg or more and less than 165 kg; And then, (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more and less than 140 kg; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg. Use of

[10] . [18-26](AA-1) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 48 kg or more and less than 50 kg; (BB-1) 195 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 66 kg or more and less than 70 kg; (CC-1) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 76 kg or more and less than 83 kg; (DD-1) 270 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 99 kg or more and less than 100 kg; A 330 mg dose of (EE-1) bispecific antibody is administered as a single loading dose once weekly for four weeks to patients weighing 111 kg or more and less than 120 kg; (FF-1) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (GG-1) 450 mg is administered as a single loading dose once weekly for four weeks to patients weighing 151 kg or more and less than 165 kg; And then, (A-1) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 48 kg or more and less than 50 kg; (B-1) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 66 kg or more and less than 70 kg; (C-1) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 76 kg or more and less than 83 kg; (D-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 99 kg or more and less than 100 kg; (E-1) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 111 kg or more and less than 120 kg; (F-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 131 kg or more and less than 140 kg; and / or (G-1) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 151 kg or more and less than 165 kg. Use of [10-2]. [18-27](AA-2) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg; (BB-2) 165 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg; A bispecific antibody (CC-2) 195 mg is administered as a single loading dose once weekly for four weeks to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg; (DD-2) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg; A bispecific antibody of (EE-2) 270 mg is administered as a single loading dose once weekly for 4 weeks to patients weighing 83 kg or more but less than 90 kg, and patients weighing more than 90 kg but less than 100 kg; (FF-2) 330 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 100 kg or more but less than 110 kg, and patients weighing more than 110 kg but less than 120 kg; (GG-2) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (HH-2) 450 mg is administered as a single loading dose once weekly for four weeks to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg; And then, (A-2) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; (B-2) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (C-2) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; (D-2) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (E-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; (F-2) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more but less than 110 kg, and greater than 110 kg but less than 120 kg; (G-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (H-2) 450 mg is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg. Use of [10-3]. [18-28](AA) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 41 kg or more and less than 50 kg; (BB) 165 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 50 kg or more and less than 60 kg; (CC) 195 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 60 kg or more and less than 70 kg; (DD) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 70 kg or more and less than 83 kg; (EE) 270 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 83 kg or more and less than 100 kg; (FF) 330 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 100 kg or more and less than 120 kg; (GG) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 120 kg or more and less than 140 kg; and / or A bispecific antibody of (HH) 450 mg is administered as a single loading dose once weekly for 4 weeks to patients weighing 140 kg or more and less than 165 kg; And then, (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; and / or (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. Use of

[14] . [18-29](AA-1) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 48 kg or more and less than 50 kg; (BB-1) 195 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 66 kg or more and less than 70 kg; (CC-1) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 76 kg or more and less than 83 kg; (DD-1) 270 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 99 kg or more and less than 100 kg; A 330 mg dose of (EE-1) bispecific antibody is administered as a single loading dose once weekly for four weeks to patients weighing 111 kg or more and less than 120 kg; (FF-1) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (GG-1) 450 mg is administered as a single loading dose once weekly for four weeks to patients weighing 151 kg or more and less than 165 kg; And then, (L-1) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 48 kg or more and less than 50 kg; (M-1) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 66 kg or more and less than 70 kg; A bispecific antibody (N-1) 450 mg is administered as a single maintenance dose once every four weeks to patients weighing 76 kg or more and less than 83 kg; A bispecific antibody of (O-1) 540 mg is administered as a single maintenance dose once every four weeks to patients weighing 99 kg or more and less than 100 kg; A bispecific antibody (P-1)660 mg is administered as a single maintenance dose once every four weeks to patients weighing 111 kg or more and less than 120 kg; (Q-1) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 131 kg or more and less than 140 kg; and / or A bispecific antibody (R-1) 900 mg is administered as a single maintenance dose once every four weeks to patients weighing 151 kg or more and less than 165 kg. Use of [14-2]. [18-30](AA-2) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 41 kg or more but less than 45 kg, and patients weighing more than 45 kg but less than 50 kg; (BB-2) 165 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 50 kg or more but less than 55 kg, and patients weighing more than 55 kg but less than 60 kg; A bispecific antibody (CC-2) 195 mg is administered as a single loading dose once weekly for four weeks to patients weighing 60 kg or more but less than 65 kg, and patients weighing more than 65 kg but less than 70 kg; (DD-2) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 70 kg or more but less than 75 kg, and patients weighing more than 75 kg but less than 83 kg; A bispecific antibody of (EE-2) 270 mg is administered as a single loading dose once weekly for 4 weeks to patients weighing 83 kg or more but less than 90 kg, and patients weighing more than 90 kg but less than 100 kg; (FF-2) 330 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 100 kg or more but less than 110 kg, and patients weighing more than 110 kg but less than 120 kg; (GG-2) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody of (HH-2) 450 mg is administered as a single loading dose once weekly for four weeks to patients weighing 140 kg or more but less than 150 kg, and patients weighing more than 150 kg but less than 165 kg; And then, (M-2) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more but less than 45 kg, and greater than 45 kg but less than 50 kg; A bispecific antibody (N-2)330 mg is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 55 kg, and greater than 55 kg but less than 60 kg; (O-2) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 65 kg, and greater than 65 kg but less than 70 kg; A bispecific antibody (P-2) 450 mg is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more but less than 75 kg, and greater than 75 kg but less than 83 kg; (Q-2) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more but less than 90 kg, and greater than 90 kg but less than 100 kg; A bispecific antibody (R-2) 660 mg is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more but less than 110 kg, and to patients weighing more than 110 kg but less than 120 kg; (S-2) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more but less than 130 kg, and greater than 130 kg but less than 140 kg; and / or A bispecific antibody (T-2) 900 mg is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more but less than 150 kg, and to patients weighing more than 150 kg but less than 165 kg. Use of [14-3]. [18-31] A maintenance dose of a bispecific antibody, for example, a maintenance dose of a bispecific antibody contained in a pharmaceutical composition, is administered to the patient one week after the last dose of the loading dose, one of the pharmaceutical compositions, bispecific antibody, method, use, kit from

[18] to [18-11], [18-13] to [18-30]. [18-32] The weight range in which the patient's weight (target weight) falls is determined before administration of a pharmaceutical composition or bispecific antibody selected from the group consisting of (aa)~(hh), (aa-1)~(gg-1), (aa-2)~(hh-2), (AA)~(HH), (AA-1)~(GG-1), (AA-2)~(HH-2), (a)~(t), (a-1)~(r-1), (a-2)~(t-2), (C1)~(C20), (CC1)~(CC8), (A)~(T), (A-1)~(R-1), and (A-2)~(T-2). [1] to [18-31] any one of the following: a pharmaceutical composition, a bispecific antibody, a method, a use, or a kit.

[19] Products for use in the treatment of a disease and / or in reducing the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The product in question is, (1) One or more containers; (2) A pharmaceutical composition comprising a bispecific antibody in an amount of 135 mg, 165 mg, 195 mg, 225 mg, 270 mg, 330 mg, 390 mg, 450 mg, 540 mg, 660 mg, 780 mg, or 900 mg, wherein the bispecific antibody comprises: a first polypeptide, each having an H chain containing a variable H chain region with amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3; a second polypeptide, each having an H chain containing a variable H chain region with amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8; and a third and fourth polypeptide, each having a common L chain containing a variable L chain region with amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The bispecific antibody is administered to the patient in accordance with instructions optionally included in the kit or preferably included in the product; and The instruction document states that the bispecific antibody is administered in a single dose. Maintenance doses of 135 mg for patients weighing 41 kg or more but less than 50 kg, 165 mg for patients weighing 50 kg or more but less than 60 kg, 195 mg for patients weighing 60 kg or more but less than 70 kg, 225 mg for patients weighing 70 kg or more but less than 83 kg, 270 mg for patients weighing 83 kg or more but less than 100 kg, 330 mg for patients weighing 100 kg or more but less than 120 kg, 390 mg for patients weighing 120 kg or more but less than 140 kg, and / or 450 mg for patients weighing 140 kg or more but less than 165 kg, every two weeks; and / or The maintenance dose is 135 mg for patients weighing 21 kg or more but less than 25 kg, 165 mg for patients weighing 25 kg or more but less than 30 kg, 195 mg for patients weighing 30 kg or more but less than 35 kg, 225 mg for patients weighing 35 kg or more but less than 41 kg, 270 mg for patients weighing 41 kg or more but less than 50 kg, 330 mg for patients weighing 50 kg or more but less than 60 kg, 390 mg for patients weighing 60 kg or more but less than 70 kg, 450 mg for patients weighing 70 kg or more but less than 83 kg, 540 mg for patients weighing 83 kg or more but less than 100 kg, 660 mg for patients weighing 100 kg or more but less than 120 kg, 780 mg for patients weighing 120 kg or more but less than 140 kg, and / or 900 mg for patients weighing 140 kg or more but less than 165 kg, every 4 weeks. Instruct that it be administered. Products. [19-1] The instruction document states that the bispecific antibody is administered in a single dose. Maintenance doses of 135 mg every two weeks for patients weighing 41 kg or more but less than 50 kg, 165 mg for patients weighing 50 kg or more but less than 60 kg, 195 mg for patients weighing 60 kg or more but less than 70 kg, 225 mg for patients weighing 70 kg or more but less than 83 kg, 270 mg for patients weighing 83 kg or more but less than 100 kg, 330 mg for patients weighing 100 kg or more but less than 120 kg, 390 mg for patients weighing 120 kg or more but less than 140 kg, and 450 mg for patients weighing 140 kg or more but less than 165 kg; and / or The maintenance dose is 135 mg for patients weighing 21 kg or more but less than 25 kg, 165 mg for patients weighing 25 kg or more but less than 30 kg, 195 mg for patients weighing 30 kg or more but less than 35 kg, 225 mg for patients weighing 35 kg or more but less than 41 kg, 270 mg for patients weighing 41 kg or more but less than 50 kg, 330 mg for patients weighing 50 kg or more but less than 60 kg, 390 mg for patients weighing 60 kg or more but less than 70 kg, 450 mg for patients weighing 70 kg or more but less than 83 kg, 540 mg for patients weighing 83 kg or more but less than 100 kg, 660 mg for patients weighing 100 kg or more but less than 120 kg, 780 mg for patients weighing 120 kg or more but less than 140 kg, and 900 mg for patients weighing 140 kg or more but less than 165 kg, administered every 4 weeks. Instruct that it be administered. Products of

[19] .

[20] The product of

[19] or [19-1] wherein the instruction document further indicates that the bispecific antibody is administered to the patient four times at one-week intervals (once a week for four times) in a loading dose of 3 mg / kg, and after the administration of the loading dose is completed, preferably one week after the last administration of the loading dose. [20-1] The product of

[20] wherein a bispecific antibody administered as a loading dose and a bispecific antibody administered as a maintenance dose, such as one contained in a pharmaceutical composition, are contained in different containers, preferably the product does not contain a container containing the loading dose. [20-2] The above instruction document, The bispecific antibody is administered to the patient four times at one-week intervals (once a week for four weeks) in a single dose, in a loading dose of a bispecific antibody selected from the group consisting of (aa) to (hh); and after the completion of the administration of the loading dose, preferably one week after the last administration of the loading dose, a maintenance dose as defined in

[19] or [19-1] is administered to the patient. Further instructions: Products of

[19] or [19-1]: (aa) For patients weighing 41 kg or more but less than 50 kg, a loading dose of 135 mg; (bb) For patients weighing 50 kg or more but less than 60 kg, a loading dose of 165 mg; (cc) A loading dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (dd) For patients weighing 70 kg or more and less than 83 kg, a loading dose of 225 mg; (ee) A loading dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (ff) A loading dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (hh) A loading dose of 450 mg for patients weighing 140 kg or more and less than 165 kg.

[21] Any one of the pharmaceutical compositions, bispecific antibodies, methods, or uses of [1]~[1-2], [2]~[2-2], [3]~[3-2], [4]~[4-2], [6], [7]~[7-3], [8]~[8-3], [9]~[9-3],

[10] ~[10-3],

[11] ~[11-3],

[12] ~[12-3],

[13] ~[13-3],

[14] ~[14-3],

[15] , [15-1],

[16] , [16-1],

[17] ~[17-4],

[18] ~[18-5], and [18-12]~[18-32], wherein the pharmaceutical composition is contained in one or more containers. [21-1] One of the kits or products of [5]~[5-2],

[16] , [16-1],

[17] ~[17-3], [18-6]~[18-11], [18-31], [18-32],

[19] , [19-1],

[20] ~[20-2], wherein the pharmaceutical composition is contained in one or more containers. [21-2] A pharmaceutical composition comprising a loading dose of a bispecific antibody selected from the group consisting of (aa)~(hh), (aa-1)~(gg-1), (aa-2)~(hh-2), (AA)~(HH), (AA-1)~(GG-1), and (AA-2)~(HH-2); a pharmaceutical composition comprising a maintenance dose of a bispecific antibody selected from the group consisting of (a)~(t), (a-1)~(r-1), (a-2)~(t-2), (A)~(T), (A-1)~(R-1), and (A-2)~(T-2); and / or from the group consisting of (C1)~(C20) and (CC1)~(CC8) A selected pharmaceutical composition is contained in one or more containers, and is one of any one of the following pharmaceutical compositions, bispecific antibodies, methods, or uses: [1]~[1-2], [2]~[2-2], [3]~[3-2], [4]~[4-2], [6], [7]~[7-3], [8]~[8-3], [9]~[9-3],

[10] ~[10-3],

[11] ~[11-3],

[12] ~[12-3],

[13] ~[13-3],

[14] ~[14-3],

[15] , [15-1],

[16] , [16-1],

[17] ~[17-4],

[18] ~[18-5], and [18-12]~[18-32]. [21-3] A pharmaceutical composition comprising a loading dose of a bispecific antibody selected from the group consisting of (aa)~(hh), (aa-1)~(gg-1), and (aa-2)~(hh-2), a pharmaceutical composition comprising a maintenance dose of a bispecific antibody selected from the group consisting of (a)~(t), (a-1)~(r-1), and (a-2)~(t-2), and / or 135 mg, 165 mg, 195 mg, 225 mg, 270 mg, 330 mg, 390 mg, 450 mg, 540 mg, 660 mg, 780 mg, or 900 mg A single kit or product from any of [5]~[5-2],

[16] , [16-1],

[17] ~[17-4], [18-6]~[18-11], [18-31], [18-32], and

[19] , [19-1],

[20] ~[20-2], wherein a pharmaceutical composition containing mg of a bispecific antibody is contained in one or more of the containers.

[22] The pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[21] or [21-1], wherein the content of the bispecific antibody contained in the pharmaceutical composition is selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg. [22-1] A pharmaceutical composition, bispecific antibody, method, use, kit, or product according to [21-2] or [21-3], wherein the content of the bispecific antibody contained in the pharmaceutical composition is selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg.

[23] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[21] , [21-1], or

[22] in which one or more containers containing a bispecific antibody in a content selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg is used per dose. [23-1] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of [21-2], [21-3], or [22-1] in which one or more containers containing a bispecific antibody in a content selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg are used per dose.

[24] A pharmaceutical composition containing a bispecific antibody in the same or different concentrations selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg, used per dose, comprising two or more containers containing one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product of

[21] , [21-1],

[22] , and

[23] . [24-1] A pharmaceutical composition containing a bispecific antibody in the same or different concentrations selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg, used per dose, comprising two or more containers containing one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product of [21-2], [21-3], [22-1], and [23-1].

[25] (1-1) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (1-2) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 50 kg or more but less than 60 kg, one container containing a pharmaceutical composition with 165 mg of bispecific antibody is used per administration; (1-3) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 60 kg or more and less than 70 kg, one container containing a pharmaceutical composition comprising 190 mg, or preferably 195 mg, of the bispecific antibody is used per administration; (1-4) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 70 kg or more and less than 83 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (1-5) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 83 kg or more and less than 100 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per administration; (1-6) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 100 kg or more but less than 120 kg, two containers, each containing a pharmaceutical composition with 165 mg of bispecific antibody, are used per administration; (1-7) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 120 kg or more and less than 140 kg, two containers, each containing a pharmaceutical composition with 195 mg of bispecific antibody, are used per administration; (1-8) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 140 kg or more and less than 165 kg, two containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration; (2-1) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 21 kg or more and less than 25 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (2-2) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 25 kg or more but less than 30 kg, one container containing a pharmaceutical composition with 165 mg of bispecific antibody is used per administration; (2-3) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 30 kg or more but less than 35 kg, one container containing a pharmaceutical composition with 195 mg of bispecific antibody is used per administration; (2-4) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 35 kg or more and less than 41 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (2-5) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per administration; (2-6) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 50 kg or more but less than 60 kg, two containers, each containing a pharmaceutical composition with 165 mg of bispecific antibody, are used per administration; (2-7) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 60 kg or more but less than 70 kg, two containers, each containing a pharmaceutical composition with 195 mg of bispecific antibody, are used per administration; (2-8) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 70 kg or more and less than 83 kg, two containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration; (2-9) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 83 kg or more and less than 100 kg, two containers, each containing a pharmaceutical composition with 270 mg of bispecific antibody, are used per administration; (2-10) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 100 kg or more but less than 120 kg, four containers, each containing a pharmaceutical composition with 165 mg of bispecific antibody, are used per administration; (2-11) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 120 kg or more and less than 140 kg, four containers, each containing a pharmaceutical composition with 195 mg of bispecific antibody, shall be used per administration; and / or (2-12) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 140 kg or more and less than 165 kg, four containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration.

[21] , [21-1], or

[22] : a pharmaceutical composition, bispecific antibody, method, use, kit, or product. [25-1](1-1) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (1-2) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 50 kg or more and less than 60 kg, one container containing a pharmaceutical composition with 165 mg of bispecific antibody is used per administration; (1-3) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 60 kg or more and less than 70 kg, one container containing a pharmaceutical composition with 195 mg of bispecific antibody is used per administration; (1-4) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 70 kg or more and less than 83 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (1-5) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 83 kg or more and less than 100 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per administration; (1-6) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 100 kg or more and less than 120 kg, two containers, each containing a pharmaceutical composition with 165 mg of bispecific antibody, are used per administration; (1-7) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 120 kg or more and less than 140 kg, two containers, each containing a pharmaceutical composition with 195 mg of bispecific antibody, are used per administration; (1-8) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient (subject) weighing 140 kg or more and less than 165 kg, two containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration; (2-1) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 21 kg or more and less than 25 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (2-2) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 25 kg or more and less than 30 kg, one container containing a pharmaceutical composition with 165 mg of bispecific antibody is used per administration; (2-3) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 30 kg or more but less than 35 kg, one container containing a pharmaceutical composition with 195 mg of bispecific antibody is used per administration; (2-4) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 35 kg or more and less than 41 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (2-5) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per administration; (2-6) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 50 kg or more and less than 60 kg, two containers, each containing a pharmaceutical composition with 165 mg of bispecific antibody, are used per administration; (2-7) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 60 kg or more but less than 70 kg, two containers, each containing a pharmaceutical composition with 195 mg of bispecific antibody, are used per administration; (2-8) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 70 kg or more and less than 83 kg, two containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration; (2-9) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 83 kg or more and less than 100 kg, two containers, each containing a pharmaceutical composition with 270 mg of bispecific antibody, are used per administration; (2-10) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 100 kg or more and less than 120 kg, four containers, each containing a pharmaceutical composition with 165 mg of bispecific antibody, are used per administration; (2-11) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 120 kg or more and less than 140 kg, four containers, each containing a pharmaceutical composition with 195 mg of bispecific antibody, are used per administration; (2-12) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient (subject) weighing 140 kg or more and less than 165 kg, four containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration; (3-1) When a bispecific antibody is administered once weekly in a loading dose to a patient (subject) weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (3-2) When a bispecific antibody is administered once weekly in a loading dose to a patient (subject) weighing 50 kg or more but less than 60 kg, one container containing a pharmaceutical composition with 165 mg of bispecific antibody is used per administration; (3-3) When a bispecific antibody is administered once weekly in a loading dose to a patient (subject) weighing 60 kg or more but less than 70 kg, one container containing a pharmaceutical composition with 195 mg of bispecific antibody is used per administration; (3-4) When a bispecific antibody is administered once weekly in a loading dose to a patient (subject) weighing 70 kg or more and less than 83 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (3-5) When a bispecific antibody is administered once weekly in a loading dose to a patient (subject) weighing 83 kg or more and less than 100 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per administration; (3-6) When a bispecific antibody is administered once weekly in a loading dose to a patient (subject) weighing 100 kg or more but less than 120 kg, two containers, each containing a pharmaceutical composition with 165 mg of bispecific antibody, are used per administration; (3-7) When a bispecific antibody is administered once weekly in a loading dose to a patient (subject) weighing 120 kg or more and less than 140 kg, two containers, each containing a pharmaceutical composition with 195 mg of bispecific antibody, shall be used per administration; and / or (3-8) When a bispecific antibody is administered once weekly at a loading dose to a patient (subject) weighing 140 kg or more and less than 165 kg, two containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration.

[21] , [21-1], [21-2], [21-3],

[22] , or pharmaceutical compositions, bispecific antibodies, methods, uses, kits, or products relating to [22-1].

[26] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of any one of

[19] , [19-1],

[20] -[20-2],

[21] -[21-3],

[22] , [22-1],

[23] , [23-1],

[24] , [24-1],

[25] , and [25-1], wherein the container is an autoinjector, vial, syringe, motorized device, needle safety device, or pen-type device.

[27] Any one of the following pharmaceutical compositions, bispecific antibodies, methods, uses, kits, or products, wherein the container is an injectable device:

[19] , [19-1],

[20] -[20-2],

[21] , [21-1]-[21-3],

[22] , [22-1],

[23] , [23-1],

[24] , [24-1],

[25] , [25-1]. [27-1] Any one of the products of [20-1], wherein the container containing a bispecific antibody administered as a loading dose is a vial, and the container containing a pharmaceutical composition containing a bispecific antibody administered as a maintenance dose is an injectable device, as well as the products of [20-1] in [21-1], [21-3],

[22] , [22-1],

[23] , [23-1],

[24] , [24-1],

[25] , and [25-1]. [27-2] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[27] or [27-1], wherein the injectable device is a durable injectable device or a disposable injectable device.

[28] The injectable device is selected from an autoinjector, syringe, motorized device, needle safety device, or pen-type device, and the pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[27] or [27-1]. [28-1] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[27] or [27-1], wherein the injectable device is an autoinjector or a syringe. [28-2] The injectable device is a prefilled syringe, or a prefilled syringe used with an autoinjector as described herein,

[27] , [27-1], or a pharmaceutically acceptable composition, bispecific antibody, method, use, kit, or product of [28-1]. [28-3] A pharmaceutical composition of any one of the following:

[21] , [21-1] to [21-3],

[22] , [22-1],

[23] , [23-1],

[24] , [24-1],

[25] , [25-1],

[26] ,

[27] to [27-2],

[28] , [28-1], and [28-2], wherein 0.2 mL to 2.1 mL of the pharmaceutical composition is contained in a container or injectable device: a pharmaceutical composition, bispecific antibody, method, use, kit, or product. [28-4] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of [28-3], wherein 0.3 mL to 2.0 mL of the pharmaceutical composition is contained in a container or injectable device. [28-5] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of [28-4], wherein 0.4 mL to 2.0 mL of the pharmaceutical composition is contained in a container or injectable device. [28-6] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of [28-5], wherein 0.9 mL to 1.8 mL of the pharmaceutical composition is contained in a container or injectable device. [28-7] 0.9 mL of pharmaceutical composition is contained in a container or injectable device for a pharmaceutical composition containing 135 mg of bispecific antibody or emicizumab; 1.1 mL of pharmaceutical composition is contained in a container or injectable device for a pharmaceutical composition containing 165 mg of bispecific antibody or emicizumab; 1.3 mL of pharmaceutical composition is contained in a container or injectable device for a pharmaceutical composition containing 195 mg of bispecific antibody or emicizumab; 1.5 mL of pharmaceutical composition is contained in a container or injectable device for a pharmaceutical composition containing 195 mg, or preferably 225 mg, of bispecific antibody or emicizumab; and / or 1.8 mL of pharmaceutical composition contains 195 mg, or preferably 270 A pharmaceutical composition containing mg of bispecific antibody or emicizumab, one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product described in

[21] , [21-1] to [21-3],

[22] , [22-1],

[23] , [23-1],

[24] , [24-1],

[25] , [25-1],

[26] ,

[27] to [27-2],

[28] , [28-1] to [28-5], contained in a container or injectable device for a pharmaceutical composition.

[29] The bispecific antibody is The first polypeptide, which has an H chain containing the H chain variable region amino acid sequence of Sequence ID No. 4; A second polypeptide, which is an H chain containing the H chain variable region amino acid sequence of SEQ ID NO: 9; and The third and fourth polypeptides, which are common light chains containing the L-chain variable region amino acid sequence of SEQ ID NO: 14. A pharmaceutical composition, bispecific antibody, method, use, kit, or product comprising any one of [1] to [28-7].

[30] The bispecific antibody is The first polypeptide, which is an H chain containing the amino acid sequence of SEQ ID NO: 5; A second polypeptide, which is an H chain containing the amino acid sequence of SEQ ID NO: 10; and The third and fourth polypeptides, which are common light chains containing the amino acid sequence of SEQ ID NO: 15. A pharmaceutical composition, bispecific antibody, method, use, kit, or product comprising any one of [1] to [28-7].

[31] Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, kits, or products of [1] to [28-7], wherein the bispecific antibody is emicizumab.

[32] A pharmaceutical composition, bispecific antibody, method, use, kit, or product from any one of [1] to

[31] , further comprising a histidine-aspartate buffer, arginine, and a surfactant. [32-1] A pharmaceutical composition, bispecific antibody, method, use, kit, or product from any one of [1] to

[31] , further comprising a histidine hydrochloride buffer, arginine, and a surfactant. [32-2] A pharmaceutical composition, bispecific antibody, method, use, kit, or product according to

[32] or [32-1], wherein the surfactant is PX188, PS20, or PS80.

[33] Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, kits, or products from [1] to

[32] , wherein the pharmaceutical composition comprises 10 mM to 40 mM histidine-aspartate buffer, 100 mM to 300 mM arginine, and 0.2 mg / ml to 1 mg / ml poloxamer 188, and has a pH of 4.5 to 6.5.

[34] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[33] , wherein the concentration of histidine in the histidine-aspartate buffer is 10 mM to 40 mM. [34-1] The pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[33] , wherein the pharmaceutical composition comprises 14 mM to 26 mM histidine-aspartate buffer, 100 mM to 200 mM arginine, and 0.25 mg / ml to 0.75 mg / ml poloxamer 188, and has a pH of 5.5 to 6.5, and the concentration of histidine in the histidine-aspartate buffer is 14 mM to 26 mM. [34-2] The pharmaceutical composition, bispecific antibody, method, use, kit, or product according to [1] to

[34] , wherein the pH of the pharmaceutical composition is 5.5 to 6.5.

[35] The pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[33] , wherein the pharmaceutical composition comprises 20 mM histidine-aspartate buffer, 150 mM arginine, and 0.5 mg / ml poloxamer 188, and has a pH of 6.

[36] The pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[35] , wherein the concentration of histidine in the histidine-aspartate buffer is 20 mM.

[37] Any one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product from [1] to

[36] , wherein the concentration of the bispecific antibody or emicizumab contained in the pharmaceutical composition is 20 mg / mL to 180 mg / mL. [37-1] Any one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product from [1] to

[36] , wherein the concentration of the bispecific antibody or emicizumab contained in the pharmaceutical composition is 135 mg / mL to 165 mg / mL.

[38] The pharmaceutical composition, bispecific antibody, method, use, kit, or product of

[37] , wherein the concentration of the bispecific antibody or emicizumab contained in the pharmaceutical composition is 150 mg / mL.

[39] A pharmaceutical composition, bispecific antibody, method, use, kit, or product from any one of

[32] to

[38] , wherein aspartate or hydrochloric acid is the counterion species for the buffer. [39-1] A pharmaceutical composition, bispecific antibody, method, use, kit, or product from any one of

[32] to

[39] , containing aspartic acid or hydrochloric acid in an amount sufficient to adjust the pH of the pharmaceutical composition.

[40] Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, kits, or products from

[32] to

[39] , wherein arginine is L-arginine, aspartic acid is L-aspartic acid, and histidine is L-histidine.

[41] Any one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product from [1] to

[31] , wherein the concentration of the bispecific antibody (emisizumab) is 150 mg / mL, and the pharmaceutical composition further comprises in an aqueous solution 3.1 mg / mL L-histidine, 26.1 mg / mL L-arginine, L-aspartate QS for pH 6.0 adjustment, and 0.5 mg / mL poloxamer 188.

[42] Any one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product from [1] to

[40] , wherein the pharmaceutical composition essentially consists of a bispecific antibody (emisizumab), histidine-aspartate buffer, arginine, and a surfactant.

[43] Any one of the pharmaceutical compositions, bispecific antibody, method, use, kit, or product of

[41] , wherein the pharmaceutical composition comprises a bispecific antibody (emisizumab), L-histidine, L-arginine, L-aspartic acid, poloxamer 188, and water.

[44] A pharmaceutically acceptable composition, bispecific antibody, method, use, kit, or product of any one of the following [1]-[5], [7]-[18-11], [18-13]-

[43] , which is characterized by a disease that develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), which is characterized by hemophilia A, hemophilia A with the appearance of inhibitors to FVIII / FVIIIa, acquired hemophilia A, or von Willebrand disease.

[45] A pharmaceutically acceptable composition, bispecific antibody, method, use, kit, or product of any one of the following [1]-[5], [7]-[18-11], [18-13]-

[43] , which is a disease that develops and / or progresses due to reduced or deficient activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), congenital hemophilia A or von Willebrand disease.

[46] Congenital hemophilia A is a disease characterized by reduced or deficient activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), and is provided for any pharmaceutical composition, bispecific antibody, method, use, kit, or product of [1]-[5], [7]-[18-11], [18-13]-

[43] .

[47] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of congenital hemophilia A, characterized by the presence of an inhibitor for FVIII / FVIIIa and congenital hemophilia A without the presence of an inhibitor for FVIII / FVIIIa, [6], [18-12],

[45] , or

[46] . [47-1] A pharmaceutical composition, bispecific antibody, method, use, kit, or product of any one of

[44] -

[47] , which treats the disease and / or reduces the incidence of the disease, thereby preventing or reducing the frequency of bleeding episodes in a patient. [47-2] Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, kits, or products of

[44] -

[47] , which treat the disease and / or reduce the incidence of the disease, is a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in a patient.

[48] ​​A pharmaceutical composition, bispecific antibody, method, use, kit, or product from any one of [1] to

[47] in which the bispecific antibody or emicizumab is administered to a human patient (subject).

[49] Any one of the pharmaceutical compositions, bispecific antibodies, methods, uses, kits, or products from [1] to

[48] , wherein the bispecific antibody or emicizumab is preferably administered subcutaneously using category-dependent fixed-dose (CFD) in combination with an autoinjector as described herein. [Brief explanation of the drawing]

[0014] [Figure 1-1]Figure 1-1 illustrates a comparison of the predicted mean ± standard deviation of steady-state exposure for dose per kg and fixed doses by category in a steady-state scenario (combined all CFD applicable categories). N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates of the original PopPK dataset. [Figure 1-2] Figure 1-2 illustrates a comparison of predicted coefficients of variation of steady-state exposure for dose per kg and fixed doses by category in a steady-state scenario (combined all CFD applicable categories). N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates of the original PopPK dataset. [Figure 2] Figure 2 illustrates a comparison of predicted values ​​for the percentage of patients achieving steady-state target exposure levels for dose per kg and fixed doses by category in steady-state scenarios (combined all CFD applicable categories). N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates of the original PopPK dataset. [Figure 3-1] Figure 3-1 illustrates the predicted course of plasma emicizumab concentration over the period of administration per kg ("PKD", weeks 0 to 24) and category-specific fixed administration ("CFD", weeks 24 to 48) in the case of Q2W administration in a switching scenario (combined all CFD applicable categories). The thick solid lines (PKD) and dotted lines (CFD) curves represent the median; the area demarcated by the thin solid line represents the 5th to 95th percentile range. N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates of the original PopPK dataset. [Figure 3-2]Figure 3-2 illustrates the predicted course of plasma emicizumab concentration over the period of dose per kg ("PKD", weeks 0 to 24) and category-specific fixed dose ("CFD", weeks 24 to 48) in the case of Q4W administration in a switching scenario (combined all CFD applicable categories). The thick solid (PKD) and dotted (CFD) curves represent the median; the area demarcated by the thin solid line represents the 5th to 95th percentile range. N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates of the original PopPK dataset. [Figure 4] Figure 4 illustrates the predicted progression of the proportion of patients achieving the target exposure level over the kg-per-dose period ("PKD", weeks 0 to 24) and the category-specific fixed dose period ("CFD", weeks 24 to 48) in the switching scenario (combined all CFD applicable categories). N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates of the original PopPK dataset. [Figure 5] Figure 5 shows a syringe with a filter compared to a standard syringe (without a filter). [Figure 6-1] Figure 6-1 illustrates the predicted course of plasma emicizumab concentration for dose per kg and fixed dose by category in the Q2W administration scenario (combined CFD applicable categories). The solid curve represents the median; the shaded area represents the 5th–95th percentile range. N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates from the original PopPK dataset. [Figure 6-2]Figure 6-2 illustrates the predicted course of plasma emicizumab concentration for dose per kg and fixed dose by category in the Q4W administration scenario (combined CFD applicable categories). The solid curve represents the median; the shaded area represents the 5th–95th percentile range. N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates from the original PopPK dataset. [Figure 7] Figure 7 illustrates the predicted progression of the percentage of patients achieving the target exposure levels for dose per kg and fixed doses by category in the initial scenario (combined all CFD applicable categories). N represents the total number of patients generated in the simulation, which is the product of the number of patients from the original PopPK dataset and the number of replicates of the original PopPK dataset. [Modes for carrying out the invention]

[0015] Description of the manner Emicizumab (also known as Hemlibra, ACE910, and RO5534262) is a bispecific antibody that recognizes (a1) blood coagulation factor IX (FIX) and / or activated blood coagulation factor IX (FIXa) and (a2) blood coagulation factor X (FX) and / or activated blood coagulation factor X (FXa), and has the activity to substitute for the function of coagulation factor VIII (FVIII).

[0016] In this disclosure, the phrase "replacing the function of FVIII" means that (a1) FIX and / or FIXa and (a2) FX and / or FXa are recognized, and the activation of FX by FIXa is promoted (FXa production by FIXa is promoted). FXa production-promoting activity can be evaluated using a measurement system comprising, for example, FIXa, FX, the synthetic substrate S-2222 (a synthetic substrate for FXa), and phospholipids. Such a measurement system shows a correlation between disease severity and clinical symptoms in hemophilia A cases (Rosen S, Andersson M, Blomback M et al. Clinical applications of a chromogenic substrate method for determination of FVIII activity. Thromb Haemost 1985; 54: 811-23).

[0017] (a1) Antibodies that recognize FIX and / or FIXa and (a2) FX and / or FXa can be obtained, for example, by following the methods described in WO2005 / 035756, WO2006 / 109592, and WO2012 / 067176. Specifically, antibodies can be produced using genetic engineering techniques known to those skilled in the art, based on the sequences of antibodies against FIX and / or FIXa and antibodies against FX and / or FXa. Based on the sequences of antibodies against FIX and / or FIXa, and antibodies against FX and / or FXa, polynucleotides encoding the antibodies can be constructed, inserted into an expression vector, and then expressed in appropriate host cells (e.g., Co, MS et al., J. Immunol. (1994) 152, 2968-2976; Better, M. and Horwitz, AH, Methods Enzymol. (1989) 178, 476-496; Pluckthun, A. and Skerra, A., Methods Enzymol. (1989) 178, 497-515; Lamoyi, E., Methods Enzymol. (1986) 121, 652-663; Rousseaux, J. et al., Methods Enzymol. (1986) 121, 663-669; and Bird, RE and Walker, See BW, Trends Biotechnol. (1991) 9, 132-137).

[0018] In this disclosure, the phrases "replacing the functions of FVIII" and "replacing the functions of FVIIIa" are used interchangeably.

[0019] Such bispecific antibodies can be isolated from or outside the host cell (e.g., from culture medium) and purified as substantially pure and homogeneous antibodies. Antibody isolation and purification can be carried out using methods commonly used for antibody isolation and purification. The methods are not limited, but antibodies can be isolated and purified by appropriately selecting and combining, for example, column chromatography columns, filters, ultrafiltration, salting out, solvent precipitation, solvent extraction, distillation, immunoprecipitation, SDS polyacrylamide gel electrophoresis, isoelectric focusing, dialysis, and recrystallization.

[0020] The bispecific antigen-binding molecules of this disclosure include, for example, the antibodies described in WO2005 / 035756, WO2006 / 109592, and WO2012 / 067176.

[0021] A bispecific antigen-binding molecule comprises a first antigen-binding site and a second antigen-binding site that can specifically bind to at least two different types of antigens. The first and second antigen-binding sites of the bispecific antigen-binding molecule of this disclosure are not particularly limited as long as they have activity to bind to (a1) FIX and / or FIXa and (a2) FX and / or FXa, respectively, but examples include sites necessary for binding to an antigen, as well as fragments containing such sites, such as antibodies, scaffold molecules (antibody-like molecules), and peptides. The scaffold molecule is a molecule that functions by binding to a target molecule, and any polypeptide can be used as long as it is a structurally stable polypeptide that can bind to at least one target antigen. Examples of such polypeptides include antibody variable regions, fibronectin (WO2002 / 032925), protein A domain (WO1995 / 001937), LDL receptor A domain (WO2004 / 044011, WO2005 / 040229), ankyrin (WO2002 / 020565), as well as molecules described by Nygren et al. (Current Opinion in Structural Biology, 7: 463-469 (1997); and Journal of Immunol Methods, 290: 3-28 (2004)), Binz et al. (Nature Biotech 23: 1257-1266 (2005)), and Hosse et al. (Protein Science 15: 14-27 (2006)). Furthermore, peptide molecules capable of binding to the target antigen may also be used, as described in Curr Opin Mol Ther. 2010 Aug; 12(4): 487-95 and Drugs. 2008; 68(7): 901-12.

[0022] Bispecific antigen-binding molecules can be produced, for example, using genetic engineering techniques (see, e.g., Borrebaeck CAK and Larrick JW, THERAPEUTIC MONOCLONAL ANTIBODIES, Published in the United Kingdom by MACMILLAN PUBLISHERS LTD, 1990). Recombinant antibodies can be obtained by cloning antibody-encoding DNA from antibody-producing cells such as hybridomas or antibody-sensitized lymphocytes, inserting it into a suitable vector, and then introducing it into a host (host cell) to produce the antibody.

[0023] Furthermore, the bispecific antigen-binding molecule may be a complete antibody, an antibody fragment, a low molecular weight antibody, or a modified antibody.

[0024] For example, antibody fragments and low molecular weight antibodies include diabody (Db), linear antibody, and single-chain antibody (hereinafter also referred to as scFv) molecules. In this specification, "Fv" fragment refers to the smallest antibody fragment, containing a complete antigen recognition site and binding site.

[0025] Bispecific antibodies include human antibodies, mouse antibodies, and rat antibodies, and their origin is not limited. They may also be genetically modified antibodies such as chimeric antibodies and humanized antibodies.

[0026] Methods for obtaining human antibodies are known. For example, human antibodies of interest can be obtained by immunizing transgenic animals that possess the entire repertoire of human antibody genes with the antigen of interest (see International Publication Numbers WO93 / 12227, WO92 / 03918, WO94 / 02602, WO94 / 25585, WO96 / 34096, and WO96 / 33735).

[0027] Genetically modified antibodies can also be produced using known methods. Specifically, for example, a chimeric antibody is an antibody that contains the variable regions of the H and L chains of an antibody from an immunized animal and the constant regions of the H and L chains of a human antibody. A chimeric antibody can be obtained by ligating the DNA encoding the variable region of an antibody derived from an immunized animal with the DNA encoding the constant region of a human antibody, inserting this into an expression vector, and then introducing this into a host cell for antibody production.

[0028] Humanized antibodies are modified antibodies, often also called reconstituted human antibodies. Humanized antibodies are constructed by transferring the CDR of an antibody derived from an immunized animal to the complementarity-determining region of a human antibody. Common genetic engineering techniques for producing them are also known (see European Patent Application Publication No. EP 239400; International Publication No. WO96 / 02576; Sato K et al., Cancer Research 1993, 53: 851-856; International Publication No. WO99 / 51743).

[0029] More specifically, the bispecific antigen-binding molecule of this disclosure is a bispecific antibody in which a first polypeptide and a third polypeptide are associated, and a second polypeptide and a fourth polypeptide are associated.

[0030] In some embodiments, the bispecific antibodies of this disclosure include: The first polypeptide is an H chain containing a variable H chain region that includes the amino acid sequences of CDR 1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR 1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing light chain variable regions, respectively, that include the amino acid sequences of CDR 1, 2, and 3 of SEQ ID NOs: 11, 12, and 13.

[0031] In some embodiments, the bispecific antibodies of this disclosure include: The first polypeptide, which has an H chain containing the H chain variable region amino acid sequence of Sequence ID No. 4; A second polypeptide, which is an H chain containing the H chain variable region amino acid sequence of SEQ ID NO: 9; and The third and fourth polypeptides, which are common light chains containing the L-chain variable region amino acid sequence of SEQ ID NO: 14.

[0032] In some embodiments, the bispecific antibodies of this disclosure include: The first polypeptide, which is an H chain containing the amino acid sequence of SEQ ID NO: 5; A second polypeptide, which is an H chain containing the amino acid sequence of SEQ ID NO: 10; and The third and fourth polypeptides (Q499-z121 / J327-z119 / L404-k) are common light chains containing the amino acid sequence of SEQ ID NO: 15.

[0033] In some embodiments, the bispecific antibody of this disclosure is emicizumab (international generic name (INN)) (alternative names are hemlibra, ACE910, and RO5534262).

[0034] In this invention, the features and definitions exemplified for emicizumab or hemlibra apply to the following bispecific antibodies (Mab1, Mab2, and Mab3), and vice versa.

[0035] Mab1: Bispecific antibody containing the following: The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing H chain variable regions containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing light chain variable regions, respectively, that include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13.

[0036] Mab2: Bispecific antibody containing the following: The first polypeptide, which has an H chain containing the H chain variable region amino acid sequence of Sequence ID No. 4; A second polypeptide, which is an H chain containing the H chain variable region amino acid sequence of SEQ ID NO: 9; and The third and fourth polypeptides, which are common light chains containing the L-chain variable region amino acid sequence of SEQ ID NO: 14.

[0037] Mab3: Bispecific antibody containing the following: The first polypeptide, which is an H chain containing the amino acid sequence of SEQ ID NO: 5; A second polypeptide, which is an H chain containing the amino acid sequence of SEQ ID NO: 10; and The third and fourth polypeptides (Q499-z121 / J327-z119 / L404-k) are common light chains containing the amino acid sequence of SEQ ID NO: 15.

[0038] Those skilled in the art will understand that the definitions and technical features provided herein in the context of bispecific antibodies (i.e., Mab1, Mab2, and Mab3) and emicizumab are applicable to pharmaceutical compositions and kits (containing said antibodies), and vice versa.

[0039] The bispecific antibodies of this disclosure may include post-translational modifications of their own sequences. Post-translational modifications include, but are not limited to, modification of glutamine or glutamic acid at the N-terminus of the ...

Claims

1. A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The pharmaceutical composition is A single dose consists of a maintenance dose of a bispecific antibody selected from the following group (a) to (h), administered to the patient every two weeks; or A single dose consists of a maintenance dose of a bispecific antibody selected from the following group (i) to (t), and is administered to the patient every four weeks. Pharmaceutical composition: (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) A maintenance dose of 450 mg for patients weighing 140 kg or more and less than 165 kg; (i) A maintenance dose of 135 mg for patients weighing 21 kg or more but less than 25 kg; (j) A maintenance dose of 165 mg for patients weighing 25 kg or more but less than 30 kg; (k) A maintenance dose of 195 mg for patients weighing 30 kg or more but less than 35 kg; (l) A maintenance dose of 225 mg for patients weighing 35 kg or more but less than 41 kg; (m) A maintenance dose of 270 mg for patients weighing 41 kg or more and less than 50 kg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg.

2. A bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa). The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The bispecific antibody is The patient is administered a maintenance dose of a bispecific antibody selected from the group consisting of (a) to (h) below as a single dose in the pharmaceutical composition, every two weeks; or The pharmaceutical composition is administered to the patient every four weeks in a maintenance dose of a bispecific antibody selected from the group consisting of (i) to (t) below. Bispecific antibodies: (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) A maintenance dose of 450 mg for patients weighing 140 kg or more and less than 165 kg; (i) A maintenance dose of 135 mg for patients weighing 21 kg or more but less than 25 kg; (j) A maintenance dose of 165 mg for patients weighing 25 kg or more but less than 30 kg; (k) A maintenance dose of 195 mg for patients weighing 30 kg or more but less than 35 kg; (l) A maintenance dose of 225 mg for patients weighing 35 kg or more but less than 41 kg; (m) A maintenance dose of 270 mg for patients weighing 41 kg or more and less than 50 kg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg.

3. A kit for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The kit is, (1) Container; (2) A pharmaceutical composition comprising a maintenance dose of a bispecific antibody selected from the group consisting of (a) to (h) below, or a maintenance dose of a bispecific antibody selected from the group consisting of (i) to (t) below. Includes, The bispecific antibody is administered to the patient in accordance with the instructions optionally included in the kit; and The instruction document states that the bispecific antibody, A single dose is administered every two weeks at a maintenance dose of a bispecific antibody selected from the following groups (a) to (h), or Each dose is administered every four weeks as a maintenance dose of a bispecific antibody selected from the following groups (i) to (t). He instructed them to do so. The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. including, kit: (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) A maintenance dose of 450 mg for patients weighing 140 kg or more and less than 165 kg; (i) A maintenance dose of 135 mg for patients weighing 21 kg or more but less than 25 kg; (j) A maintenance dose of 165 mg for patients weighing 25 kg or more but less than 30 kg; (k) A maintenance dose of 195 mg for patients weighing 30 kg or more but less than 35 kg; (l) A maintenance dose of 225 mg for patients weighing 35 kg or more but less than 41 kg; (m) A maintenance dose of 270 mg for patients weighing 41 kg or more and less than 50 kg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; and (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg.

4. A pharmaceutical composition containing a bispecific antibody, The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, Select from the following groups (C1) to (C20): Pharmaceutical composition: (C1) A pharmaceutical composition comprising 135 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 41 kg or more and less than 50 kg, administered once every two weeks; (C2) A pharmaceutical composition comprising 165 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 50 kg or more but less than 60 kg, administered once every two weeks; (C3) A pharmaceutical composition comprising 195 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 60 kg or more but less than 70 kg, administered once every two weeks; (C4) A pharmaceutical composition comprising 225 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 70 kg or more and less than 83 kg, administered once every two weeks; (C5) A pharmaceutical composition comprising 270 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 83 kg or more and less than 100 kg, administered once every two weeks; (C6) A pharmaceutical composition comprising 330 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 100 kg or more and less than 120 kg, administered once every two weeks; (C7) A pharmaceutical composition comprising 390 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 120 kg or more and less than 140 kg, administered once every two weeks; (C8) A pharmaceutical composition comprising 450 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 140 kg or more and less than 165 kg, administered once every two weeks; (C9) A pharmaceutical composition comprising 135 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 21 kg or more and less than 25 kg, administered once every four weeks; (C10) A pharmaceutical composition comprising 165 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 25 kg or more and less than 30 kg, administered once every four weeks; (C11) A pharmaceutical composition comprising 195 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 30 kg or more and less than 35 kg, administered once every four weeks; (C12) A pharmaceutical composition comprising 225 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 35 kg or more and less than 41 kg, administered once every four weeks; (C13) A pharmaceutical composition comprising 270 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 41 kg or more and less than 50 kg, administered once every four weeks; (C14) A pharmaceutical composition comprising 330 mg of bispecific antibody for use in administration once every four weeks to patients with congenital hemophilia A who weigh 50 kg or more and less than 60 kg; (C15) A pharmaceutical composition comprising 390 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 60 kg or more but less than 70 kg, administered once every four weeks; (C16) A pharmaceutical composition comprising 450 mg of bispecific antibody for use in patients with congenital hemophilia A weighing 70 kg or more and less than 83 kg, administered once every four weeks; (C17) A pharmaceutical composition comprising 540 mg of bispecific antibody for use in administration once every four weeks to patients with congenital hemophilia A whose body weight is 83 kg or more and less than 100 kg; (C18) A pharmaceutical composition comprising 660 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 100 kg or more and less than 120 kg, administered once every four weeks; (C19) A pharmaceutical composition comprising 780 mg of bispecific antibody for use in administration once every four weeks to patients with congenital hemophilia A whose body weight is 120 kg or more and less than 140 kg; and (C20) A pharmaceutical composition containing 900 mg of bispecific antibody for use in patients with congenital hemophilia A who weigh 140 kg or more and less than 165 kg, administered once every four weeks.

5. A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more but less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more but less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more and less than 140 kg; and (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg. Pharmaceutical composition.

6. A bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa). The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (A) 135 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more and less than 140 kg; and (H) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 140 kg or more and less than 165 kg. Bispecific antibodies.

7. A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. Pharmaceutical composition.

8. A bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa). The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (I) 135 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 140 kg or more and less than 165 kg. Bispecific antibodies.

9. (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more but less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more but less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more but less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 120 kg or more and less than 140 kg; (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg; (I) 135 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 30 kg or more but less than 35 kg; (L) 225 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more but less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. The pharmaceutical composition according to claim 5 or 7.

10. (A) 135 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered once every two weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 120 kg or more and less than 140 kg; (H) 450 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every two weeks to patients weighing 140 kg or more and less than 165 kg; (I) 135 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 21 kg or more and less than 25 kg; (J) 165 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 25 kg or more and less than 30 kg; (K) 195 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 30 kg or more and less than 35 kg; (L) 225 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 35 kg or more and less than 41 kg; (M) 270 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 60 kg or more and less than 70 kg; (P) 450 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered once every four weeks as a single maintenance dose in the pharmaceutical composition to patients weighing 120 kg or more and less than 140 kg; and (T) 900 mg of bispecific antibody is administered as a single maintenance dose in the pharmaceutical composition once every four weeks to patients weighing 140 kg or more and less than 165 kg. The bispecific antibody according to claim 6 or 8.

11. The bispecific antibody is administered to the patient at a loading dose of 3 mg / kg four times at one-week intervals (once a week for four weeks); and After completing the administration of the loading dose, from the fifth dose onward, the bispecific antibody is administered to the patient every two weeks at a maintenance dose selected from the groups (a) to (h), (C1) to (C8), and (A) to (H), or the bispecific antibody is administered to the patient every four weeks at a maintenance dose selected from the groups (i) to (t), (C9) to (C20), and (I) to (T). (a) to (h) are defined in claim 1, 2, or 3; (C1) to (C8) are defined in claim 4; (A) to (H) are defined in claims 5, 6, 9, or 10; (i) to (t) are defined in claim 1, 2, or 3; (C9) to (C20) are defined in claim 4; (I) to (T) are defined in claim 7, 8, 9, or 10. A pharmaceutical composition, bispecific antibody, or kit according to any one of claims 1 to 10.

12. A single dose of a bispecific antibody selected from the group consisting of (aa) to (hh) contained in the pharmaceutical composition is administered to the patient once a week for four weeks; Thereafter, a maintenance dose of a bispecific antibody, selected from the group consisting of (a) to (h) as defined in claim 1 or 2, which is contained in the pharmaceutical composition, is administered to the patient every two weeks as a single dose; (aa) to (hh) and (a) to (h) are as follows: The pharmaceutical composition or bispecific antibody according to any one of claims 1 and 2: (aa) A loading dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (bb) A loading dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (cc) A loading dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (dd) A loading dose of 225 mg for patients weighing 70 kg or more and less than 83 kg; (ee) A loading dose of 270 mg for patients weighing 83 kg or more and less than 100 kg; (ff) A loading dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients weighing 120 kg or more and less than 140 kg; (hh) A loading dose of 450 mg for patients weighing 140 kg or more and less than 165 kg; (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) A maintenance dose of 450 mg for patients weighing 140 kg or more and less than 165 kg.

13. A single dose of a bispecific antibody selected from the group consisting of (aa) to (hh) contained in the pharmaceutical composition is administered to the patient once a week for four weeks; Thereafter, a maintenance dose of a bispecific antibody selected from the group consisting of (m) to (t) as defined in claim 1 or 2 is administered to the patient every four weeks; (aa) to (hh) and (m) to (t) are as follows: The pharmaceutical composition or bispecific antibody according to any one of claims 1 and 2: (aa) A loading dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (bb) A loading dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (cc) A loading dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (dd) A loading dose of 225 mg for patients weighing 70 kg or more and less than 83 kg; (ee) A loading dose of 270 mg for patients weighing 83 kg or more and less than 100 kg; (ff) A loading dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients weighing 120 kg or more and less than 140 kg; (hh) A loading dose of 450 mg for patients weighing 140 kg or more and less than 165 kg; (m) A maintenance dose of 270 mg for patients weighing 41 kg or more and less than 50 kg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg.

14. The aforementioned instruction document, The bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa) to (hh); Furthermore, a maintenance dose of a bispecific antibody selected from the group consisting of (a) to (h) as defined in claim 5 is administered to the patient every two weeks. Further instructions were given to: (aa) to (hh) and (a) to (h) are as follows: The kit according to claim 5: (aa) A loading dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (bb) A loading dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (cc) A loading dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (dd) A loading dose of 225 mg for patients weighing 70 kg or more and less than 83 kg; (ee) A loading dose of 270 mg for patients weighing 83 kg or more and less than 100 kg; (ff) A loading dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients weighing 120 kg or more and less than 140 kg; (hh) A loading dose of 450 mg for patients weighing 140 kg or more and less than 165 kg; (a) A maintenance dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (b) A maintenance dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (c) A maintenance dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (d) A maintenance dose of 225 mg for patients weighing 70 kg or more but less than 83 kg; (e) A maintenance dose of 270 mg for patients weighing 83 kg or more but less than 100 kg; (f) A maintenance dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (g) A maintenance dose of 390 mg for patients weighing 120 kg or more but less than 140 kg; (h) A maintenance dose of 450 mg for patients weighing 140 kg or more and less than 165 kg.

15. The aforementioned instruction document, The bispecific antibody is administered to the patient once a week for four weeks, with a single dose consisting of a loading dose of a bispecific antibody selected from the group (aa) to (hh); Furthermore, a maintenance dose of a bispecific antibody selected from the group consisting of (m) to (t) as defined in claim 5 is administered to the patient every four weeks. Further instructions were given to: (aa) to (hh) and (m) to (t) are as follows: The kit according to claim 5: (aa) A loading dose of 135 mg for patients weighing 41 kg or more but less than 50 kg; (bb) A loading dose of 165 mg for patients weighing 50 kg or more but less than 60 kg; (cc) A loading dose of 195 mg for patients weighing 60 kg or more but less than 70 kg; (dd) A loading dose of 225 mg for patients weighing 70 kg or more and less than 83 kg; (ee) A loading dose of 270 mg for patients weighing 83 kg or more and less than 100 kg; (ff) A loading dose of 330 mg for patients weighing 100 kg or more but less than 120 kg; (gg) A loading dose of 390 mg for patients weighing 120 kg or more and less than 140 kg; (hh) A loading dose of 450 mg for patients weighing 140 kg or more and less than 165 kg; (m) A maintenance dose of 270 mg for patients weighing 41 kg or more and less than 50 kg; (n) A maintenance dose of 330 mg for patients weighing 50 kg or more but less than 60 kg; (o) A maintenance dose of 390 mg for patients weighing 60 kg or more but less than 70 kg; (p) A maintenance dose of 450 mg for patients weighing 70 kg or more but less than 83 kg; (q) A maintenance dose of 540 mg for patients weighing 83 kg or more but less than 100 kg; (r) A maintenance dose of 660 mg for patients weighing 100 kg or more but less than 120 kg; (s) A maintenance dose of 780 mg for patients weighing 120 kg or more and less than 140 kg; (t) A maintenance dose of 900 mg for patients weighing 140 kg or more and less than 165 kg.

16. A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (AA) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 41 kg or more and less than 50 kg; (BB) 165 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 50 kg or more and less than 60 kg; (CC) 195 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 60 kg or more and less than 70 kg; (DD) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 70 kg or more and less than 83 kg; (EE) 270 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 83 kg or more and less than 100 kg; (FF) 330 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 100 kg or more and less than 120 kg; (GG) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 120 kg or more and less than 140 kg; and / or A bispecific antibody of (HH) 450 mg is administered as a single loading dose once weekly for 4 weeks to patients weighing 140 kg or more and less than 165 kg; And then, (A) 135 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 41 kg or more and less than 50 kg; (B) 165 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 50 kg or more and less than 60 kg; (C) 195 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 60 kg or more and less than 70 kg; (D) 225 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 70 kg or more and less than 83 kg; (E) 270 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 83 kg or more and less than 100 kg; (F) 330 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 100 kg or more and less than 120 kg; (G) 390 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to the patient weighing 120 kg or more and less than 140 kg; and / or (H) 450 mg of bispecific antibody is administered as a single maintenance dose once every two weeks to patients weighing 140 kg or more and less than 165 kg. Pharmaceutical composition.

17. A pharmaceutical composition comprising a bispecific antibody for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The bispecific antibody is The first polypeptide is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3, respectively; A second polypeptide, which is an H chain containing an H chain variable region containing the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8, respectively; and The third and fourth polypeptides are common light chains containing the light chain variable regions, respectively, which include the amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, (AA) 135 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 41 kg or more and less than 50 kg; (BB) 165 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 50 kg or more and less than 60 kg; (CC) 195 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 60 kg or more and less than 70 kg; (DD) 225 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 70 kg or more and less than 83 kg; (EE) 270 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 83 kg or more and less than 100 kg; (FF) 330 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 100 kg or more and less than 120 kg; (GG) 390 mg of bispecific antibody is administered as a single loading dose once weekly for 4 weeks to patients weighing 120 kg or more and less than 140 kg; and / or A bispecific antibody of (HH) 450 mg is administered as a single loading dose once weekly for 4 weeks to patients weighing 140 kg or more and less than 165 kg; And then, (M) 270 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 41 kg or more and less than 50 kg; (N) 330 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 50 kg or more and less than 60 kg; (O) 390 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 60 kg or more but less than 70 kg; (P) 450 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 70 kg or more and less than 83 kg; (Q) 540 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 83 kg or more and less than 100 kg; (R) 660 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 100 kg or more and less than 120 kg; (S) 780 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 120 kg or more and less than 140 kg; (T) 900 mg of bispecific antibody is administered as a single maintenance dose once every four weeks to patients weighing 140 kg or more and less than 165 kg. Pharmaceutical composition.

18. Products for use in the treatment of a disease and / or the reduction of the incidence of the disease, wherein the disease is caused and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa), The product in question is, (1) One or more containers; (2) A pharmaceutical composition comprising a bispecific antibody in an amount of 135 mg, 165 mg, 195 mg, 225 mg, 270 mg, 330 mg, 390 mg, 450 mg, 540 mg, 660 mg, 780 mg, or 900 mg, wherein the bispecific antibody comprises a first polypeptide, each having an H chain containing a variable H chain region with amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 1, 2, and 3; a second polypeptide, each having an H chain containing a variable H chain region with amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 6, 7, and 8; and a third and fourth polypeptide, each having a common L chain containing a variable L chain region with amino acid sequences of CDR1, 2, and 3 of SEQ ID NOs: 11, 12, and 13. Includes, The bispecific antibody is administered to the patient in accordance with instructions optionally included in the kit or preferably included in the product; and The instruction document states that the bispecific antibody is administered in a single dose. Maintenance doses of 135 mg every two weeks for patients weighing 41 kg or more but less than 50 kg, 165 mg for patients weighing 50 kg or more but less than 60 kg, 195 mg for patients weighing 60 kg or more but less than 70 kg, 225 mg for patients weighing 70 kg or more but less than 83 kg, 270 mg for patients weighing 83 kg or more but less than 100 kg, 330 mg for patients weighing 100 kg or more but less than 120 kg, 390 mg for patients weighing 120 kg or more but less than 140 kg, and 450 mg for patients weighing 140 kg or more but less than 165 kg; and / or The maintenance dose is 135 mg for patients weighing 21 kg or more but less than 25 kg, 165 mg for patients weighing 25 kg or more but less than 30 kg, 195 mg for patients weighing 30 kg or more but less than 35 kg, 225 mg for patients weighing 35 kg or more but less than 41 kg, 270 mg for patients weighing 41 kg or more but less than 50 kg, 330 mg for patients weighing 50 kg or more but less than 60 kg, 390 mg for patients weighing 60 kg or more but less than 70 kg, 450 mg for patients weighing 70 kg or more but less than 83 kg, 540 mg for patients weighing 83 kg or more but less than 100 kg, 660 mg for patients weighing 100 kg or more but less than 120 kg, 780 mg for patients weighing 120 kg or more but less than 140 kg, and 900 mg for patients weighing 140 kg or more but less than 165 kg, administered every 4 weeks. Instruct that it be administered. Products.

19. The pharmaceutical composition or bispecific antibody according to any one of claims 1, 2, and 4 to 11, 12, 13, 16, and 17, wherein the pharmaceutical composition is contained in one or more containers.

20. The kit or product according to claim 3, 11, 14, 15, or 18, wherein the pharmaceutical composition is contained in one or more containers.

21. The pharmaceutical composition, bispecific antibody, kit, or product according to claim 19 or 20, wherein the content of the bispecific antibody contained in the pharmaceutical composition is selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg.

22. A pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 19 to 21, wherein one or more containers containing a pharmaceutical composition comprising a bispecific antibody in a content selected from the group consisting of 135 mg, 165 mg, 195 mg, 225 mg, and 270 mg are used per dose.

23. (1-1) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (1-2) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 50 kg or more and less than 60 kg, one container containing a pharmaceutical composition with 165 mg of the bispecific antibody is used per administration; (1-3) When the bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 60 kg or more and less than 70 kg, one container containing a pharmaceutical composition comprising 190 mg, or preferably 195 mg, of the bispecific antibody is used per administration; (1-4) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 70 kg or more and less than 83 kg, one container containing a pharmaceutical composition with 225 mg of the bispecific antibody is used per administration; (1-5) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 83 kg or more and less than 100 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per administration; (1-6) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 100 kg or more and less than 120 kg, two containers, each containing a pharmaceutical composition with 165 mg of the bispecific antibody, are used per administration; (1-7) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 120 kg or more and less than 140 kg, two containers, each containing a pharmaceutical composition with 195 mg of the bispecific antibody, are used per administration; (1-8) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 140 kg or more and less than 165 kg, two containers, each containing a pharmaceutical composition with 225 mg of the bispecific antibody, are used per administration; (2-1) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 21 kg or more and less than 25 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (2-2) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 25 kg or more and less than 30 kg, one container containing a pharmaceutical composition with 165 mg of the bispecific antibody is used per administration; (2-3) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 30 kg or more and less than 35 kg, one container containing a pharmaceutical composition with 195 mg of the bispecific antibody is used per administration; (2-4) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 35 kg or more and less than 41 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (2-5) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 270 mg of the bispecific antibody is used per administration; (2-6) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 50 kg or more and less than 60 kg, two containers, each containing a pharmaceutical composition with 165 mg of the bispecific antibody, are used per administration; (2-7) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 60 kg or more and less than 70 kg, two containers, each containing a pharmaceutical composition with 195 mg of the bispecific antibody, are used per administration; (2-8) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 70 kg or more and less than 83 kg, two containers, each containing a pharmaceutical composition with 225 mg of the bispecific antibody, are used per administration; (2-9) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 83 kg or more and less than 100 kg, two containers, each containing a pharmaceutical composition with 270 mg of the bispecific antibody, are used per administration; (2-10) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 100 kg or more and less than 120 kg, four containers, each containing a pharmaceutical composition with 165 mg of the bispecific antibody, are used per administration; (2-11) When the bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 120 kg or more and less than 140 kg, four containers, each containing a pharmaceutical composition with 195 mg of the bispecific antibody, are used per administration; and / or (2-12) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 140 kg or more and less than 165 kg, four containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration. A pharmaceutical composition, bispecific antibody, method, use, kit, or product according to any one of claims 19 to 21.

24. (1-1) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (1-2) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 50 kg or more and less than 60 kg, one container containing a pharmaceutical composition with 165 mg of the bispecific antibody is used per administration; (1-3) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 60 kg or more and less than 70 kg, one container containing a pharmaceutical composition with 195 mg of the bispecific antibody is used per administration; (1-4) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 70 kg or more and less than 83 kg, one container containing a pharmaceutical composition with 225 mg of the bispecific antibody is used per administration; (1-5) When a bispecific antibody is administered at a maintenance dose every two weeks to a patient weighing 83 kg or more and less than 100 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per administration; (1-6) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 100 kg or more and less than 120 kg, two containers, each containing a pharmaceutical composition with 165 mg of the bispecific antibody, are used per administration; (1-7) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 120 kg or more and less than 140 kg, two containers, each containing a pharmaceutical composition with 195 mg of the bispecific antibody, are used per administration; (1-8) When the bispecific antibody is administered at a maintenance dose every two weeks to patients weighing 140 kg or more and less than 165 kg, two containers, each containing a pharmaceutical composition with 225 mg of the bispecific antibody, are used per administration; (2-1) When a bispecific antibody is administered at a maintenance dose every four weeks to a patient weighing 21 kg or more and less than 25 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (2-2) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 25 kg or more and less than 30 kg, one container containing a pharmaceutical composition with 165 mg of the bispecific antibody is used per administration; (2-3) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 30 kg or more and less than 35 kg, one container containing a pharmaceutical composition with 195 mg of the bispecific antibody is used per administration; (2-4) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 35 kg or more and less than 41 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (2-5) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 41 kg or more and less than 50 kg, one container containing a pharmaceutical composition with 270 mg of the bispecific antibody is used per administration; (2-6) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 50 kg or more and less than 60 kg, two containers, each containing a pharmaceutical composition with 165 mg of the bispecific antibody, are used per administration; (2-7) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 60 kg or more and less than 70 kg, two containers, each containing a pharmaceutical composition with 195 mg of the bispecific antibody, are used per administration; (2-8) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 70 kg or more and less than 83 kg, two containers, each containing a pharmaceutical composition with 225 mg of the bispecific antibody, are used per administration; (2-9) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 83 kg or more and less than 100 kg, two containers, each containing a pharmaceutical composition with 270 mg of the bispecific antibody, are used per administration; (2-10) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 100 kg or more and less than 120 kg, four containers, each containing a pharmaceutical composition with 165 mg of the bispecific antibody, are used per administration; (2-11) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 120 kg or more and less than 140 kg, four containers, each containing a pharmaceutical composition with 195 mg of the bispecific antibody, are used per administration; (2-12) When the bispecific antibody is administered at a maintenance dose every four weeks to patients weighing 140 kg or more and less than 165 kg, four containers, each containing a pharmaceutical composition with 225 mg of the bispecific antibody, are used per administration; (3-1) When a bispecific antibody is administered once weekly in a loading dose to a patient weighing 41 kg or more but less than 50 kg, one container containing a pharmaceutical composition with 135 mg of bispecific antibody is used per administration; (3-2) When the bispecific antibody is administered once weekly in a loading dose to a patient weighing 50 kg or more but less than 60 kg, one container containing a pharmaceutical composition with 165 mg of the bispecific antibody is used per administration; (3-3) When the bispecific antibody is administered once weekly in a loading dose to a patient weighing 60 kg or more but less than 70 kg, one container containing a pharmaceutical composition with 195 mg of the bispecific antibody is used per dose; (3-4) When the bispecific antibody is administered once weekly in a loading dose to a patient weighing 70 kg or more and less than 83 kg, one container containing a pharmaceutical composition with 225 mg of bispecific antibody is used per administration; (3-5) When a bispecific antibody is administered once weekly in a loading dose to a patient weighing 83 kg or more but less than 100 kg, one container containing a pharmaceutical composition with 270 mg of bispecific antibody is used per dose; (3-6) When the bispecific antibody is administered once weekly in a loading dose to a patient weighing 100 kg or more but less than 120 kg, two containers, each containing a pharmaceutical composition with 165 mg of the bispecific antibody, are used per administration; (3-7) When the bispecific antibody is administered once weekly in a loading dose to a patient weighing 120 kg or more and less than 140 kg, two containers, each containing a pharmaceutical composition with 195 mg of the bispecific antibody, are used per administration; and / or (3-8) When a bispecific antibody is administered once weekly in a loading dose to a patient weighing 140 kg or more and less than 165 kg, two containers, each containing a pharmaceutical composition with 225 mg of bispecific antibody, are used per administration. A pharmaceutical composition, bispecific antibody, method, use, kit, or product according to any one of claims 19 to 21.

25. The pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 18 to 24, wherein the container is an auto-injector, vial, syringe, motorized device, needle safety device, or pen-type device.

26. The pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 18 to 24, wherein the container is an injectable device.

27. The pharmaceutical composition, bispecific antibody, kit, or product according to claim 26, wherein the injectable device is an autoinjector or a syringe.

28. The pharmaceutical composition, bispecific antibody, method, use, kit, or product according to claim 26 or 27, wherein the injectable device is a prefilled syringe or a prefilled syringe used with an autoinjector as described herein.

29. A pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 19 to 28, wherein 0.2 mL to 2.1 mL of the pharmaceutical composition is contained in the container or injectable device.

30. The aforementioned bispecific antibody The first polypeptide, which is an H chain containing the H chain variable region amino acid sequence of Sequence ID No. 4; A second polypeptide, which is an H chain containing the H chain variable region amino acid sequence of Sequence ID No. 9; and Sequence ID: 14 ​​is a common light chain containing the amino acid sequence of the light chain variable region of the third and fourth polypeptides. A pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 29, comprising:

31. The aforementioned bispecific antibody The first polypeptide is an H chain containing the amino acid sequence of SEQ ID NO: 5; Sequence ID: A second polypeptide, which is an H chain containing the amino acid sequence of 10; and Sequence ID: 15 amino acid sequences, common light chains, third and fourth polypeptides. A pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 29, comprising:

32. The pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 30, wherein the bispecific antibody is emicizumab.

33. The pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 32, further comprising a histidine-aspartate buffer, arginine, and a surfactant.

34. The pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 33, comprising 10 mM to 40 mM histidine-aspartate buffer, 100 mM to 300 mM arginine, and 0.2 mg / ml to 1 mg / ml poloxamer 188, and having a pH of 4.5 to 6.

5.

35. The pharmaceutical composition, bispecific antibody, kit, or product according to claim 34, wherein the concentration of histidine in the histidine-aspartate buffer is 10 mM to 40 mM.

36. The pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 35, wherein the concentration of the bispecific antibody or emicizumab contained in the pharmaceutical composition is 135 mg / mL to 165 mg / mL.

37. The pharmaceutical composition, bispecific antibody, method, use, kit, or product according to claims 1 to 35, wherein the concentration of the bispecific antibody or emicizumab contained in the pharmaceutical composition is 150 mg / mL.

38. A pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 3, 5 to 37, wherein the disease that develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa) is hemophilia A, hemophilia A with the appearance of inhibitors against FVIII / FVIIIa, acquired hemophilia A, or von Willebrand disease.

39. A pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 3, 5 to 37, wherein the disease that develops and / or progresses due to a decrease or deficiency of the activity of blood coagulation factor VIII (FVIII) and / or activated blood coagulation factor VIII (FVIIIa) is congenital hemophilia A or von Willebrand disease.

40. A pharmaceutical composition, bispecific antibody, kit, or product according to claim 4 or 40, wherein congenital hemophilia A is congenital hemophilia A with the appearance of inhibitors to FVIII / FVIIIa, and congenital hemophilia A without the appearance of inhibitors to FVIII / FVIIIa.

41. A pharmaceutical composition, bispecific antibody, kit, or product according to any one of claims 1 to 40, wherein the bispecific antibody or emicizumab is administered subcutaneously.

42. A method for treating hemophilia A (congenital factor VIII deficiency) with or without a factor VIII inhibitor, comprising the step of administering a pharmaceutical composition containing emicizumab to a patient having hemophilia A (congenital factor VIII deficiency) with or without a factor VIII inhibitor, (A) If the patient's weight is 41 kg or more but less than 50 kg, 135 mg of emicizumab is administered once every two weeks as a single maintenance dose; (B) If the patient's weight is 50 kg or more but less than 60 kg, 165 mg of emicizumab is administered once every two weeks as a single maintenance dose; (C) If the patient's weight is 60 kg or more but less than 70 kg, 195 mg of emicizumab is administered once every two weeks as a single maintenance dose; (D) If the patient weighs 70 kg or more but less than 83 kg, 225 mg of emicizumab is administered once every two weeks as a single maintenance dose; (E) If the patient's weight is 83 kg or more but less than 100 kg, 270 mg of emicizumab is administered once every two weeks as a single maintenance dose; (F) If the patient's weight is 100 kg or more but less than 120 kg, 330 mg of emicizumab is administered once every two weeks as a single maintenance dose; (G) If the patient's weight is 120 kg or more but less than 140 kg, 390 mg of emicizumab is administered once every two weeks as a single maintenance dose; (H) If the patient's weight is 140 kg or more but less than 165 kg, 450 mg of emicizumab is administered once every two weeks as a single maintenance dose; (I) If the patient's weight is 21 kg or more but less than 25 kg, 135 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (J) If the patient's weight is 25 kg or more but less than 30 kg, 165 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (K) If the patient's weight is 30 kg or more but less than 35 kg, 195 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (L) If the patient's weight is 35 kg or more but less than 41 kg, 225 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (M) If the patient's weight is 41 kg or more but less than 50 kg, 270 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (N) If the patient's weight is 50 kg or more but less than 60 kg, 330 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (O) If the patient's weight is 60 kg or more but less than 70 kg, 390 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (P) If the patient's weight is 70 kg or more but less than 83 kg, 450 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (Q) If the patient's weight is 83 kg or more but less than 100 kg, 540 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (R) If the patient's weight is between 100 kg and 120 kg, 660 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (S) If the patient's weight is 120 kg or more but less than 140 kg, 780 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; or (T) If the patient's weight is 140 kg or more and less than 165 kg, 900 mg of bispecific antibody is administered once every 4 weeks as a single maintenance dose. method.

43. A routine prophylactic method for preventing or reducing the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) who have or do not have a factor VIII inhibitor, comprising the step of administering a pharmaceutical composition containing emicizumab to the patient, (A) If the patient's weight is 41 kg or more but less than 50 kg, 135 mg of emicizumab is administered once every two weeks as a single maintenance dose; (B) If the patient's weight is 50 kg or more but less than 60 kg, 165 mg of emicizumab is administered once every two weeks as a single maintenance dose; (C) If the patient's weight is 60 kg or more but less than 70 kg, 195 mg of emicizumab is administered once every two weeks as a single maintenance dose; (D) If the patient weighs 70 kg or more but less than 83 kg, 225 mg of emicizumab is administered once every two weeks as a single maintenance dose; (E) If the patient's weight is 83 kg or more but less than 100 kg, 270 mg of emicizumab is administered once every two weeks as a single maintenance dose; (F) If the patient's weight is 100 kg or more but less than 120 kg, 330 mg of emicizumab is administered once every two weeks as a single maintenance dose; (G) If the patient's weight is 120 kg or more but less than 140 kg, 390 mg of emicizumab is administered once every two weeks as a single maintenance dose; (H) If the patient's weight is 140 kg or more but less than 165 kg, 450 mg of emicizumab is administered once every two weeks as a single maintenance dose; (I) If the patient's weight is 21 kg or more but less than 25 kg, 135 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (J) If the patient's weight is 25 kg or more but less than 30 kg, 165 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (K) If the patient's weight is 30 kg or more but less than 35 kg, 195 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (L) If the patient's weight is 35 kg or more but less than 41 kg, 225 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (M) If the patient's weight is 41 kg or more but less than 50 kg, 270 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (N) If the patient's weight is 50 kg or more but less than 60 kg, 330 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (O) If the patient's weight is 60 kg or more but less than 70 kg, 390 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (P) If the patient's weight is 70 kg or more but less than 83 kg, 450 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (Q) If the patient's weight is 83 kg or more but less than 100 kg, 540 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (R) If the patient's weight is between 100 kg and 120 kg, 660 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; (S) If the patient's weight is 120 kg or more but less than 140 kg, 780 mg of bispecific antibody is administered once every four weeks as a single maintenance dose; or (T) If the patient's weight is 140 kg or more and less than 165 kg, 900 mg of bispecific antibody is administered once every 4 weeks as a single maintenance dose. method.

44. A routine prophylactic method for preventing or reducing the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) who have or do not have a factor VIII inhibitor, comprising the step of administering a pharmaceutical composition containing emicizumab to the patient, (a1) A step of determining whether the patient's weight is 41 kg or more and less than 50 kg; and (b1) If the patient's weight is 41 kg or more but less than 50 kg, administer 135 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a2) A step of determining whether the patient's weight is 50 kg or more and less than 60 kg; and (b2) If the patient's weight is 50 kg or more but less than 60 kg, administer 165 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a3) A step of determining whether the patient's weight is 60 kg or more and less than 70 kg; and (b3) If the patient's weight is 60 kg or more but less than 70 kg, administer 195 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a4) A step of determining whether the patient's weight is 70 kg or more and less than 83 kg; and (b4) If the patient's weight is 70 kg or more but less than 83 kg, administer 225 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a5) A step of determining whether the patient's weight is 83 kg or more and less than 100 kg; and (b5) If the patient's weight is 83 kg or more but less than 100 kg, administer 270 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a6) A step of determining whether the patient's weight is 100 kg or more and less than 120 kg; and (b6) If the patient's weight is 100 kg or more but less than 120 kg, administer 330 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a7) A step of determining whether the patient's weight is 120 kg or more and less than 140 kg; and (b7) If the patient's weight is 120 kg or more but less than 140 kg, administer 390 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a8) A step of determining whether the patient's weight is 140 kg or more and less than 165 kg; and (b8) If the patient's weight is 140 kg or more but less than 165 kg, administer 450 mg of emicizumab to the patient once every two weeks as a single maintenance dose; or (a9) A step of determining whether the patient's weight is 21 kg or more and less than 25 kg; and (b9) If the patient's weight is 21 kg or more but less than 25 kg, administer 135 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a10) A step of determining whether the patient's weight is 25 kg or more and less than 30 kg; and (b10) If the patient's weight is 25 kg or more but less than 30 kg, administer 165 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a11) A step of determining whether the patient's weight is 30 kg or more and less than 35 kg; and (b11) If the patient's weight is 30 kg or more but less than 35 kg, administer 195 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a12) A step of determining whether the patient's weight is 35 kg or more and less than 41 kg; and (b12) If the patient's weight is 35 kg or more but less than 41 kg, administer 225 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a13) A step of determining whether the patient's weight is 41 kg or more and less than 50 kg; and (b13) If the patient's weight is 41 kg or more but less than 50 kg, administer 270 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a14) A step of determining whether the patient's weight is 50 kg or more and less than 60 kg; and (b14) If the patient's weight is 50 kg or more but less than 60 kg, administer 330 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a15) A step of determining whether the patient's weight is 60 kg or more and less than 70 kg; and (b15) If the patient's weight is 60 kg or more but less than 70 kg, administer 390 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a16) A step of determining whether the patient's weight is 70 kg or more and less than 83 kg; and (b16) If the patient's weight is 70 kg or more but less than 83 kg, administer 450 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a17) A step of determining whether the patient's weight is 83 kg or more and less than 100 kg; and (b17) If the patient's weight is 83 kg or more but less than 100 kg, administer 540 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a18) A step of determining whether the patient's weight is 100 kg or more and less than 120 kg; and (b18) If the patient's weight is 100 kg or more but less than 120 kg, administer 660 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a19) A step of determining whether the patient's weight is 120 kg or more and less than 140 kg; and (b19) If the patient's weight is 120 kg or more but less than 140 kg, administer 780 mg of emicizumab to the patient once every four weeks as a single maintenance dose; or (a20) A step of determining whether the patient's weight is 140 kg or more and less than 165 kg; and (b20) If the patient's weight is 140 kg or more and less than 165 kg, administer 900 mg of emicizumab to the patient once every four weeks as a single maintenance dose. Methods that include...

45. A product comprising a subcutaneous administration device for delivering 135 mg of emicizumab to a patient, wherein the device contains 0.9 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL and is delivered to the patient.

46. A product comprising a subcutaneous administration device for delivering 165 mg of emicizumab to a patient, wherein the device contains and delivers 1.1 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL.

47. A product comprising a subcutaneous administration device for delivering 195 mg of emicizumab to a patient, wherein the device contains and delivers 1.3 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL.

48. A product comprising a subcutaneous administration device for delivering 225 mg of emicizumab to a patient, wherein the device contains and delivers 1.5 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL.

49. A product comprising a subcutaneous administration device for delivering 270 mg of emicizumab to a patient, wherein the device contains 1.8 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL and is delivered to the patient.

50. The product according to any one of claims 37 to 41, wherein the subcutaneous administration device is a syringe.

51. The product according to claim 42, wherein the syringe is a pre-filled syringe.

52. A routine prophylactic method for preventing or reducing the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) who have or do not have a factor VIII inhibitor, comprising the step of administering a pharmaceutical composition containing emicizumab to the patient, A. If the patient's weight is 41 kg or more but less than 50 kg, A subcutaneous injection device for delivering 135 mg of emicizumab to a patient, the device for delivering 0.9 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 135 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; B. If the patient's weight is 50 kg or more but less than 60 kg, A subcutaneous injection device for delivering 165 mg of emicizumab to a patient, the device for delivering 1.1 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 165 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; C. If the patient's weight is 60 kg or more but less than 70 kg, A subcutaneous injection device for delivering 195 mg of emicizumab to a patient, the device for delivering 1.3 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 195 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; D. If the patient's weight is 70 kg or more but less than 83 kg, A subcutaneous injection device containing and delivering 225 mg of emicizumab to a patient, and containing and delivering 1.5 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. the device Using this method, 225 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; E. If the patient's weight is 83 kg or more but less than 100 kg, A subcutaneous injection device for delivering 270 mg of emicizumab to a patient, the device for delivering 1.8 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 270 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; F. If the patient's weight is 100 kg or more but less than 120 kg, Two subcutaneous injection devices (e.g., preffilled syringes) each containing 165 mg of emicizumab and delivering it to the patient, each containing 1.1 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL and delivering it to the patient. Using this method, 330 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; G. If the patient's weight is 120 kg or more but less than 140 kg, A single subcutaneous injection device (e.g., a pre-filled syringe) containing 195 mg of emicizumab and delivering it to the patient, each containing 1.3 mL of a pharmaceutical composition with a concentration of 150 mg / mL of emicizumab and delivering it to the patient. Using this method, 390 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; H. If the patient's weight is 140 kg or more and less than 165 kg, Two subcutaneous injection devices (e.g., pre-filled syringes) each containing 225 mg of emicizumab and delivering it to the patient, each containing 1.5 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL and delivering it to the patient. Using this method, 450 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; I. If the patient's weight is 21 kg or more but less than 25 kg, A subcutaneous injection device for delivering 135 mg of emicizumab to a patient, the device for delivering 0.9 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 135 mg of emicizumab is administered subcutaneously once every four weeks as a single maintenance dose; J. If the patient's weight is 25 kg or more but less than 30 kg, A subcutaneous injection device for delivering 165 mg of emicizumab to a patient, the device for delivering 1.1 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 165 mg of emicizumab is administered subcutaneously once every four weeks as a single maintenance dose; K. If the patient's weight is 30 kg or more but less than 35 kg, A subcutaneous injection device for delivering 195 mg of emicizumab to a patient, the device for delivering 1.3 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 195 mg of emicizumab is administered subcutaneously once every four weeks as a single maintenance dose; L. If the patient's weight is 35 kg or more and less than 41 kg, A subcutaneous injection device for delivering 135 mg of emicizumab to a patient, the device for delivering 1.5 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 225 mg of emicizumab is administered subcutaneously once every four weeks as a single maintenance dose; M. If the patient's weight is 41 kg or more but less than 50 kg, A subcutaneous injection device for delivering 270 mg of emicizumab to a patient, the device for delivering 1.8 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL to the patient. Using this method, 270 mg of emicizumab is administered subcutaneously once every four weeks as a single maintenance dose; N. If the patient's weight is 50 kg or more but less than 60 kg, Two subcutaneous injection devices (e.g., pre-filled syringes) each containing 165 mg of emicizumab and delivering it to the patient, each containing 1.1 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL and delivering it to the patient. Using this method, 330 mg of emicizumab is administered subcutaneously once every four weeks as a single maintenance dose; O. If the patient's weight is 60 kg or more but less than 70 kg, A single subcutaneous injection device (e.g., a pre-filled syringe) containing 195 mg of emicizumab and delivering it to the patient, each containing 1.3 mL of a pharmaceutical composition with a concentration of 150 mg / mL of emicizumab and delivering it to the patient. Using this method, 390 mg of emicizumab is administered subcutaneously once every four weeks as a single maintenance dose; P. If the patient's weight is 70 kg or more but less than 83 kg, Two subcutaneous injection devices (e.g., pre-filled syringes) each containing 225 mg of emicizumab and delivering it to the patient, each containing 1.5 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL and delivering it to the patient. Using this method, 450 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; Q. If the patient's weight is 83 kg or more but less than 100 kg, Two subcutaneous injection devices (e.g., pre-filled syringes) each containing 270 mg of emicizumab and delivering it to the patient, each containing 1.8 mL of a pharmaceutical composition containing emicizumab at a concentration of 150 mg / mL and delivering it to the patient. Using this method, 540 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; R. If the patient's weight is 100 kg or more but less than 120 kg, Four subcutaneous injection devices (e.g., pre-filled syringes) for delivering 165 mg of emicizumab to the patient, each containing 1.1 mL of a pharmaceutical composition with a concentration of 150 mg / mL of emicizumab for delivery to the patient. Using this method, 660 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; S. If the patient's weight is 120 kg or more but less than 140 kg, Four subcutaneous injection devices (e.g., pre-filled syringes) for delivering 195 mg of emicizumab to the patient, each containing 1.3 mL of a pharmaceutical composition with a concentration of 150 mg / mL of emicizumab for delivery to the patient. Using this method, 780 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose; or T. If the patient's weight is 140 kg or more and less than 165 kg, Four subcutaneous injection devices (e.g., pre-filled syringes) for delivering 225 mg of emicizumab to the patient, each containing 1.5 mL of a pharmaceutical composition with a concentration of 150 mg / mL of emicizumab for delivery to the patient. Using this method, 900 mg of emicizumab is administered subcutaneously once every two weeks as a single maintenance dose. method.

53. The method according to claim 44, wherein in (A) to (E), (G), (I) to (M), and (O), the subcutaneous injection device is a syringe, or in (F), (H), (N), and (P) to (T), the subcutaneous injection device is a syringe.

54. The method according to claim 45, wherein in (A) to (E), (G), (I) to (M), and (O), the syringe is a pre-filled syringe, or in (F), (H), (N), and (P) to (T), the syringe is a pre-filled syringe.

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