Direct drug infusion device and method using label as hanger

Abstract

An apparatus and method are provided for infusing medication directly from a vial to a patient. To facilitate direct infusion of medication, such as one or more pharmaceuticals, biopharmaceuticals, and / or biologicals, from the vial to a patient, a movable hanger label is provided for adhering to and supporting the vial. Additionally, a process is provided in which medication contained within a vial having a movable hanger label can be primed at a rapid infusion rate and directly infused through an infusion line. A saline flush is incorporated at the end of administration to flush the infusion line and reduce the amount of medication remaining in the line.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 62 / 966,495, filed January 27, 2020, the contents of which are incorporated herein by reference in their entirety.

[0002] The present subject matter described herein relates generally to vial-to-patient drug infusion. More specifically, the subject matter relates to devices and methods for providing direct vial-to-patient drug infusion. [Background technology]

[0003] Infusion of a medication, such as one or more pharmaceuticals, biopharmaceuticals, and / or biologicals, can involve intravenous administration of the medication to a patient. One or more healthcare providers may be responsible for the intravenous administration, which may include, for example, dose preparation procedures and patient preparation procedures to provide the patient with the medication to be administered intravenously. Summary of the Invention

[0004] Aspects of the present subject matter relate to infusing medication directly from a vial to a patient, thereby simplifying healthcare provider workflow and reducing patient infusion time.

[0005] This innovation simplifies healthcare worker workflow by enabling undiluted liquid drug solutions to be infused intravenously (IV) directly from the primary container. This eliminates the need for dilution in the IV bag prior to administration, shortening infusion time and providing healthcare systems with a more convenient and faster IV administration option. Significantly reduced infusion time also promises to improve the patient experience.

[0006] According to an aspect disclosed herein, an apparatus is provided. The apparatus includes a label. The label includes a back region and a front region opposite the back region. A movable hanger is included in a portion of the back region of the label and a portion opposite the front region of the label. The movable hanger is configured to move from a first position to a second position. In the first position, the movable hanger is at least substantially aligned between a remainder of the back region and a remainder opposite the front region. In the second position, the movable hanger is at least partially separated from the remainder of the back region and the remainder opposite the front region.

[0007] In some variations, the label may include one or more features disclosed herein, including the following features, in any operable combination. In some variations, the remainder of the back region of the label may be configured to adhere to the outer sidewall of the vial. In some variations, the label may comprise a flexible material. In some variations, the back region may include a portion of the back region and a remainder of the back region, and the front region may include a portion opposite the front region and a remainder opposite the front region. In some variations, the label may further include perforations extending through the back region and the front region, and the perforations may define at least a portion of the periphery of the movable hanger. In some variations, the perforations may be configured to at least partially separate the movable hanger from the remainder of the back region and the remainder opposite the front region. In some variations, the movable hanger may be configured to move from a first position to a second position along the perforations. In some variations, the movable hanger in the second position may be in a loop configuration, and the loop configuration may include two fixed ends. In some variations, the movable hanger in the second position may be configured to support the vial from the infusion stand when the label is attached to the vial. In some variations, the movable hanger in the second position may be positioned so that the vial hangs substantially downward from the infusion stand. In some variations, the label may include text in the front region, and when the vial hangs substantially downward, the text may be upside down, right side up, or a combination thereof. In some variations, the movable hanger in the second position may be configured to support a vial weight of up to approximately 500 kg. In some variations, the length of the label may be between approximately 75 mm and approximately 100 mm. In some variations, the height of the label may be between approximately 30 mm and approximately 40 mm. In some variations, the width of the movable hanger may be between approximately 5 mm and approximately 7 mm.

[0008] In another interrelated aspect, a method is provided that includes infusing a first amount of saline into an infusion line via an infusion pump; removing a vial cap from a vial containing a medication, the vial including a stopper thereon and configured to cover the stopper; piercing the stopper with an infusion line spike at a proximal end of the infusion line; opening a movable hanger from a label attached to the vial into a loop configuration, the movable hanger being formed from a portion of the label and configured to move from a closed configuration to the loop configuration; and suspending the vial from an infusion stand via the movable hanger.

[0009] In some variations, the method may include one or more features disclosed herein, including the following features, in any operable combination. In some variations, the method may further include opening an air vent cap on an infusion line spike; and setting an infusion rate and volume of a medication to be administered to the patient in an infusion pump, whereby the medication may travel from the vial through the infusion line spike, through the infusion line, and into a needle inserted into the patient, the needle may be disposed at a distal end of the infusion line, and the infusion pump is coupled to the infusion line to deliver the medication at the infusion rate. In some variations, the method may further include infusing a second medication through the infusion line for administration to the patient after administration of the medication to the patient is complete, via the infusion pump, where the second medication may be the same type of medication as the medication or a different type of medication. In some variations, the method may further include infusing a second amount of saline into the infusion line via the infusion pump. In some variations, less than 1.5% of the initial amount of medication may remain in the infusion line after infusion of the second amount of saline for up to about 30 minutes at an infusion rate of about 3 mL / min, where the infusion time may include the medication administration time and the second saline flush time. In some variations, less than 5% of the initial amount of medication may remain in the infusion line after infusion of the second amount of saline for up to about 10 minutes at an infusion rate of about 6 mL / min, where the infusion time may include the medication administration time and the second saline flush time. In some variations, the medication may not be diluted prior to administration. In some variations, the initial amount of medication in the vial may be less than about 30 mL. In some variations, the movable hanger may be formed from a portion of the back region and an opposite portion of the front region of the label. In some variations, the label may include perforations extending through the back region and the front region of the label, and the perforations may further include defining at least a portion of the perimeter of the movable hanger. In some variations, the perforations may be configured to open the movable hanger from a closed configuration to a loop configuration.

[0010] In another interrelated aspect, an apparatus is provided that includes means for infusing a first amount of saline into an infusion line, means for infusing a medication from a vial into the infusion line for administering the medication to a patient, and means for infusing a second amount of saline into the infusion line upon completion of administration of the medication to the patient. The vial is suspended from an infusion stand via a movable hanger formed from a portion of a label attached to the vial, the movable hanger being configured to move from a closed configuration to a loop configuration.

[0011] In another interrelated aspect, a method of administering a medication to a patient in need thereof is provided, the method including infusing a first amount of saline to the patient via an infusion line, infusing a dose of medication from a vial to the patient for a first time period via the infusion line, where the initial amount of medication in the vial is about 30 mL or less and is not diluted prior to infusion to the patient, and infusing a second amount of saline to the patient via the infusion line for a second time period. After infusing the second amount of saline, less than about 5% of the initial amount remains in the infusion line.

[0012] In some variations, the present invention may include one or more features disclosed herein, including the following features, in any operable combination. In some variations, the medication may be administered in a fixed dose. In some variations, the initial amount of medication in the vial may be about 10 mL or less. In some variations, the sum of the first and second time periods may be about 60 minutes or less. In some variations, the sum of the first and second time periods may be about 30 minutes or less. In some variations, the sum of the first and second time periods may be about 15 minutes or less. In some variations, less than about 1.5% of the initial amount may remain in the infusion line after infusing the second amount of saline. In some variations, the infusion volume of the medication may be between about 10 mL and about 30 mL, and the second amount of saline may be between about 25 mL and about 90 mL. In some variations, the medication and the second amount of saline may be infused into the patient at an infusion rate of between about 1 mL / min and about 10 mL / min.

[0013] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate certain aspects of the subject matter disclosed herein and, together with the detailed description, serve to explain some of the principles associated with the disclosed embodiments. In the following drawings: [Brief explanation of the drawings]

[0015] [Figure 1A] 1 illustrates features of a movable hanger label configured to adhere to and support a vial consistent with the practice of the present subject matter. [Figure 1B] 1 illustrates features of a movable hanger label configured to adhere to and support a vial consistent with the practice of the present subject matter. [Figure 2A]1 illustrates features of a movable hanger label configured to adhere to and support a vial consistent with the practice of the present subject matter. [Figure 2B] 1 illustrates features of a movable hanger label configured to adhere to and support a vial consistent with the practice of the present subject matter. [Figure 3A] 1 shows a side view of a movable hanger label attached to a vial consistent with the practice of the present subject matter. [Figure 3B] 1 shows a side view of a movable hanger label attached to a vial consistent with the practice of the present subject matter. [Figure 4] FIG. 10 shows a side view of an infusion line spike for direct medication infusion that may employ a movable hanger label consistent with the practice of the present subject matter. [Figure 5A] 1 is a graph of the concentration of 840 mg of atezolizumab (Atezo) as a function of time infused over 30 minutes at an infusion rate of 3 milliliters per minute (mL / min) consistent with the practice of the present subject matter. [Figure 5B] 1 is a graph of the concentration of 840 mg of atezolizumab (Atezo) as a function of time infused over 10 minutes at an infusion rate of 6 mL / min consistent with the practice of the present subject matter. [Figure 6A] 1 is a graph of the concentration of 1200 mg of atezolizumab (Atezo) as a function of time infused over 30 minutes at an infusion rate of 3 mL / min consistent with the practice of the present subject matter. [Figure 6B] 1 is a graph of the concentration of 1200 mg of atezolizumab (Atezo) as a function of time infused over 10 minutes at an infusion rate of 6 mL / min consistent with the practice of the present subject matter. [Figure 7A] 1 is a graph of the concentration of 1680 mg of atezolizumab (Atezo) as a function of time infused over 30 minutes at an infusion rate of 3 mL / min consistent with the practice of the present subject matter. [Figure 7B] 1 is a graph of the concentration as a function of time of 1680 mg of atezolizumab (Atezo) infused over 10 minutes at an infusion rate of 6 mL / min consistent with an embodiment of the present subject matter. DETAILED DESCRIPTION OF THE INVENTION

[0016] Wherever practical, like reference numerals refer to like structures, features, or elements.

[0017] I. Definition "Patient" or "subject in need thereof" means an organism suffering from or susceptible to a disease or condition that can be treated by administration of a pharmaceutical composition as provided herein. Non-limiting examples include humans, other mammals, cows, rats, mice, dogs, cats, monkeys, goats, sheep, cattle, deer, and other non-mammals. In some embodiments, the patient is a human.

[0018] Dosage may vary depending on the requirements of the patient and the compound employed. In the context of the present disclosure, the dose administered to a patient should be sufficient to produce a beneficial therapeutic response in the patient over time. The size of the dose will also be determined by the presence, nature, and severity of side effects. Determining the appropriate dosage for a particular situation is within the skill of a medical professional. Dosage amounts and intervals can be individually adjusted to provide a level of the administered compound that is effective for the specific clinical indication being treated. This allows for the provision of a treatment that is commensurate with the severity of the individual's condition.

[0019] II. Pharmaceutical Compositions As used herein, "anticancer agent" refers to a molecule (e.g., a compound, peptide, protein, nucleic acid) used to treat cancer by destroying or inhibiting cancer cells or tissues. Anticancer agents may act selectively on specific cancers or specific tissues. In embodiments, anticancer agents herein may include epigenetic inhibitors and multikinase inhibitors.

[0020] Octreotide; Oxenon; Oligonucleotides; Onapristone; Ondansetron; Ondansetron; Oracin; Oral cytokine inducers; Ormaplatin; Osateron; Oxaliplatin; Oxaunomycin; Palauamine; Palmitoylrhizoxin; Pamidronate; Panaxytriol; Panomyphen; Parabactin; Pazeliptin; Pegaspargase; Perdecin; Pentosan polysulfate sodium; Pentostatin; Pentrozole; Perflubron; Perfosfamide; Perillyl alcohol ;Phenazinomycin;Phenylacetate;Phosphatase inhibitors;Picibanil;Pilocarpine hydrochloride;Pirarubicin;Piritlexim;Prasetin A;Prasetin B;Plasminogen activator inhibitors;Platinum complexes;Platinum compounds;Platinum-triamine complexes;Porfimer sodium;Porfiromycin;Prednisone;Propylbis-acridone;Prostaglandin J2;Proteasome inhibitors;Protein A-based immunomodulators;Protein kinase C inhibitors;Protein kinase C inhibitors,Microalgae; protein tyrosine phosphatase inhibitors; purine nucleoside phosphorylase inhibitors; purpurins; pyrazoloacridines; pyridoxylated hemoglobin polyoxyethyl ether conjugates; raf antagonists; raltitrexed; ramosetron; ras farnesyl protein transferase inhibitors; ras inhibitors; ras-GAP inhibitors; demethylated reterliptin; rhenium Re186 etidronate; rhizoxin; ribozymes; RII retinamide; rogletimide; rohitukin; romurtide; roquinimex; rubidino B1; Ruboxil; Safingol; Santopine; SarCNU; Sarcophytol A; Sargramostim; Sdi1 mimetic; Semustine; Senescence-derived inhibitor 1; Sense oligonucleotide; Signal transduction inhibitor; Signal transduction modulator; Single-chain antigen-binding protein; Sizofuran; Sobuzoxane; Sodium borocaptate; Sodium phenylacetate; Soberol; Somatomedin-binding protein; Sonermin; Sparfosic acid; Spicamycin D; Spiromustine; Splenopentin; Spongestatin 1; Squalamine; Stem cell inhibitors; stem cell division inhibitors; stipiamid; stromelysin inhibitors; sulfinosine; superactive vasoactive intestinal peptide antagonists; sladista; suramin; swainsonine; synthetic glycosaminoglycans; talimustine; tamoxifen methiodide; tauromustine; tazarotene; tecogalan sodium; tegafur; tellapyrylium; telomerase inhibitors; temoporfin; temozolomide; teniposide; tetrachlorodecaoxide; tetrazomine; taliblaster; thiocoraline; thrombopoietin; thrombopoietin mimetics ;Thymalfasin;Thymopoietin receptor agonists;Thymotrin;Thyroid-stimulating hormone;Tin ethyl etiopurpurin;Tirapazamine;Titanocene dichloride;Topsentin;Toremifene;Totipotent stem cell factor;Translation inhibitors;Tretinoin;Triacetyluridine;Triciribine;Trimetrexate;Triptorelin;Tropisetron;Turosteride;Tyrosine kinase inhibitors;Tyrphostins;UBC inhibitors;Ubenimex;Urogenital sinus-derived growth inhibitor;Urokinase receptor antagonists;Vapreotide;Variolin B;Vector systems,Red blood cell gene therapy; Veraresol; Veramine; Verdin; Verteporfin; Vinorelbine; Vinsartin; Vitaxin; Vorozole; Zanoterone; Zeniplatin; Zilascove; Zinostatin stimalamer, Adriamycin, Dactinomycin, Bleomycin, Vinblastine, Cisplatin, Acivicin; Aclarubicin; Acodazole hydrochloride; Acronine; Adzelesin; Aldesleukin; Altretamine; Ambomycin; Amethantrone acetate; Aminoglutethimide; Amsacrine; Anas Trozole; Anthramycin; Asparaginase; Asperlin; Azacitidine; Azetepa; Azotomycin; Batimastat; Benzodepa; Bicalutamide; Bisantrene hydrochloride; Visnafide dimesylate; Bizelesin; Bleomycin sulfate; Brequinar sodium; Bropirimine; Busulfan; Cactinomycin; Calsterone; Carasemide; Carbetimer; Carboplatin; Carmustine; Carubicin hydrochloride; Carzelesin; Cedefingol; Chlorambucil; Cilolemycin; Cladrivi methadone;crisnatol mesylate;cyclophosphamide;cytarabine;dacarbazine;daunorubicin hydrochloride;decitabine;dexorumaplatin;dezaguanine;dezaguanine mesylate;diaziquone;doxorubicin;doxorubicin hydrochloride;droloxifene;droloxifene citrate;drostanolone propionate;duazomycin;edatrexate;eflornithine hydrochloride;elsamitrucin;enloplatin;enpromate;epipropidin;epirubicin hydrochloride;elbrozole;esorubicin fluticasone hydrochloride; estramustine; estramustine sodium phosphate; etanidazole; etoposide; etoposide phosphate; etopurine; fadrozole hydrochloride; fazarabine; fenretinide; floxuridine; fludarabine phosphate; fluorouracil; fluorocitabine; fosquidone; fostriecin sodium; gemcitabine; gemcitabine hydrochloride; hydroxyurea; idarubicin hydrochloride; ifosfamide; imofosine; interleukin I1 (including recombinant interleukin II, or rlL2),Interferon alfa-2a; interferon alfa-2b; interferon alfa-n1; interferon alfa-n3; interferon beta-1a; interferon gamma-1b; iproplatin; irinotecan hydrochloride; lanreotide acetate; letrozole; leuprolide acetate; riazole hydrochloride; lometrexol sodium; lomustine; losoxantrone hydrochloride; masoprocol; maytansine; mechlorethamine hydrochloride; megestrol acetate; melengestrol acetate; melphalan; menogaril; mercaptopurine; me Thotrexate; Methotrexate sodium; Metoprine; Metuadepa; Mitindomide; Mitocalcin; Mitochromin; Mitogillin; Mitomarcin; Mitomycin; Mitospar; Mitotane; Mitoxantrone hydrochloride; Mycophenolic acid; Nocodazoie; Nogalamycin; Ormaplatin; Oxisuran; Pegaspargase; Periomycin; Pentamustine; Peplomycin sulfate; Perfosfamide; Pipobroman; Piposulfan; Piroxantrone hydrochloride; Plicamycin; Promestane; Porfimer sodium; Porfiromycin acetaminophen;Prednimustine;Procarbazine hydrochloride;Puromycin;Puromycin hydrochloride;Pirazofurin;Rivopurin;Rogletimide;Safingol;Safingol hydrochloride;Semustine;Mutrazene;Sparfosate sodium;Sparsomycin;Spirogermanium hydrochloride;Spiromustine;Spiroplatin;Streptonigrin;Streptozocin;Sulfophenol;Tallysomycin;Tecogalan sodium;Tegafur;Teroxantrone hydrochloride;Temoporfin;Teniposide;Teroxylon;Testolactone;Thiamiprine;Tioguam Ninine; Thiotepa; Tiazofurin; Tirapazamine; Toremifene citrate; Treston acetate; Triciribine phosphate; Trimetrexate; Trimetrexate glucuronate; Triptorelin; Tubrozole hydrochloride; Uracil mustard; Uredepa; Vapreotide; Verteporfin; Vinblastine sulfate; Vincristine sulfate; Vindesine; Vindesine sulfate; Binepidine sulfate; Vingrisinate sulfate; Vinleurosine sulfate; Vinorelbine tartrate; Vinrocidine sulfate; Vinzolidine sulfate; Vorozole; Zeniplatin; Zinostatin; Zorubicin hydrochloride,Agents that arrest cells in the G2-M phase and / or modulate the formation or stability of microtubules (e.g., Taxol™ (i.e., paclitaxel), Taxotere™, compounds containing a taxane skeleton, elbrozole (i.e., R-55104), dolastatin 10 (i.e., DLS-10 and NSC-376128), mibobulin isethionate (i.e., CI-980), vincristine, NSC-639829, discodamolide (i.e., NVP-XX-A-296), ABT-751 (Abbott, i.e., E-7010), altorhyrtin (e.g., altorhyrtin A and and altruhirtin C), spongistatins (e.g., spongistatin 1, spongistatin 2, spongistatin 3, spongistatin 4, spongistatin 5, spongistatin 6, spongistatin 7, spongistatin 8, and spongistatin 9), cemadotin hydrochloride (i.e., LU-103793 and NSC-D-669356), epothilones (e.g., epothilone A, epothilone B, epothilone C (i.e., desoxyepothilone A or dEpoA), epothilone D (i.e., KOS-862, dEpoB, and desoxyepothilone B), epothilone E, epothilone F, epothilone B N-oxide, epothilone A N-oxide, 16-aza-epothilone B, 21-aminoepothilone B (i.e., BMS-310705), 21-hydroxyepothilone D (i.e., desoxyepothilone F and dEpoF), 26-fluoroepothilone, auristatin PE (i.e., NSC-654663), sobridotin (i.e., TZT-1027), LS-4559-P (Pharmacia, i.e., LS-45 77), LS-4578 (Pharmacia, i.e., LS-477-P), LS-4477 (Pharmacia), LS-4559 (Pharmacia), RPR-112378 (Aventis), vincristine sulfate, DZ-3358 (Daiichi), FR-182877 (Fujisawa, i.e., WS-9885B), GS-164 (Takeda), GS-198 (Takeda), KAR-2 (Hungarian Academy of Sciences), BSF-223651 (BASF, i.e., ILX-651 and LU-223651),SAH-49960 (Lilly / Novartis), SDZ-268970 (Lilly / Novartis), AM-97 (Armad / Kyowa Hakko), AM-132 (Armad), AM-138 (Armad / Kyowa Hakko), IDN-5005 (Indena), cryptophycin 52 (i.e., LY-355703), AC-7739 (Ajinomoto, i.e., AVE-8063A and CS-39.HCl), AC-7700 (Ajinomoto, i.e., AVE-8062, AVE-8062A, CS-39-L-Ser.HCl, and RPR-258062A), vitilevuamide, tubulysin A, Canadensol, Centaureidin (i.e., NSC-106969), T-138067 (Tularik, i.e., T-67, TL-138067, and TI-138067), COBRA-1 (Parker Hughes Institute, i.e., DDE-261 and WHI-261), H10 (Kansas State University), H16 (Kansas State University), Oncocidin A1 (i.e., BTO-956 and DIME), DDE-313 (Parker Hughes Institute), Physianolide B, Laulimalide, SPA-2 (Parker Hughes Institute), SPA-1 (Parker Hughes Institute, i.e., SPIKET-P), 3-IAABU (cytoskeleton / Mount Sinai School of Medicine, i.e., MF-569), narcosine (also known as NSC-5366), nascapine, D-24851 (Asta Medica), A-105972 (Abbott), hemiasterlin, 3-BAABU (cytoskeleton / Mount Sinai School of Medicine, i.e., MF-191), TMPN (Arizona State University), vanadocene acetylacetonate, T-138026 (Tularik), monsatrol, inanosin (i.e., NSC-698666), 3-IAABU (cytoskeleton / Mount Sinai School of Medicine, i.e., MF-569), narcosine (also known as NSC-5366), nascapine, D-24851 (Asta Medica). Medica), A-105972 (Abbott), hemiasterlin, 3-BAABU (Cytoskeleton / Mount Sinai School of Medicine, i.e., MF-191), TMPN (Arizona State University), vanadocene acetylacetonate, T-138026 (Tularik), monsatrol, inanosin (i.e., NSC-698666), 3-IAABE (Cytoskeleton / Mount Sinai School of Medicine), A-204197 (Abbott), T-607 (Tularik, i.e., T-900607), RPR-115781 (Aventis), eleutherobin (desmethylleutherobin, desmethylleutherobin, isoeleutherobin A, Z-eleutherobin, etc.), carbaeoside, carbaeolin, halichondrin B, D-64131 (Asta Medica), D-68144 (Asta Medica), diazonamide A, A-293620 (Abbott), NPI-2350 (Nereus), taccalonolide A, TUB-245 (Aventis), A-259754 (Abbott), diozostatin, (-)-phenylahistine (i.e., NSCL-96F037), D-68838 (Asta Medica), D-68836 (AstaMedica), myoseverin B, D-43411 (Zentaris, i.e., D-81862), A-289099 (Abbott), A-318315 (Abbott), HTI-286 (i.e., SPA-110, trifluoroacetate) (Wyeth), D-82317 (Zentaris), D-82318 (Zentaris), SC-12983 (NCI), resbellastatin sodium phosphate, BPR-OY-007 (National Health Research Institute) These include steroids (e.g., dexamethasone), finasteride, aromatase inhibitors, gonadotropin-releasing hormone agonists (GnRH) such as goserelin or leuprolide, adrenergic corticosteroids (e.g., prednisone), progestins (e.g., hydroxyprogesterone caproate, megestrol acetate, medroxyprogesterone acetate), esophageal ulcers (e.g., steroids), and steroids (e.g., steroids). Antibodies include strogens (e.g., dietristilbestrol, ethinyl estradiol), antiestrogens (e.g., tamoxifen), androgens (e.g., testosterone propionate, fluoxymesterone), antiandrogens, immunostimulants (e.g., bacillus calmette-guerin (BCG), levamisole, interleukin-2, alpha interferon, etc.), monoclonal antibodies (e.g., anti-CD20, anti-HER2, anti-CD52, anti-HLA-DR, and anti-VEGF monoclonal antibodies), immunotoxins (e.g., anti-CD33 monoclonal antibody-calicheamicin conjugate, anti-CD22 monoclonal antibody-Pseudomonas exotoxin conjugate, etc.), radioimmunotherapy (e.g., anti-CD20 monoclonal antibody conjugated to 111In, 90Y, or131I, etc.), triptolide, homoharringtonine, dactinomycin, doxorubicin, epirubicin, topotecan, itraconazole, vindesine, cerivastatin, vincristine, deoxyadenosine, sertraline, pitavastatin, EGFR irinotecan, clofazimine, 5-nonyloxytryptamine, vemurafen, epidermal growth factor receptor (EGFR) targeted therapies or therapeutics (e.g., gefitinib (Iressa™), erlotinib (Tarceva™), cetuximab (Erbitux™), lapatinib (Tykerb™), panitumumab (Vectibix™), vandetanib (Caprelsa™), afatinib / BIBW2992, CI-1033 / canertinib, neratinib / HKI-272, CP-724714, TAK-285, AST-1306, ARRY334543, ARRY-380, AG-1478, dacomitinib / PF299804, OSI-420 / desmethylerlotinib, AZD8931, AEE788, pelitinib / EKB-569, CUDC-101, WZ8040, WZ4002, WZ3146, AG-490, XL647, PD153035, BMS-599626), sorafenib, imatinib, sunitinib, dasatinib, etc. In one embodiment, the anti-cancer agent is an immune checkpoint inhibitor (e.g., atezolizumab (Tecentriq®), pembrolizumab (Keytruda®), ipilimumab, nivolumab (Opdivo®), avelumab, durvalumab, cemiplimab, or spartalizumab).

[0021] III.How to use As used herein, the term "administering" generally refers to intravenous administration unless otherwise indicated. Other forms of administration include, but are not limited to, administration as a suppository, topical contact, oral administration, parenteral administration, intraperitoneal administration, intramuscular administration, intranasal administration, intrathecal administration, nasal administration, subcutaneous administration, sustained-release devices such as mini-osmotic pumps, transmucosal (e.g., buccal, sublingual, palatal, gingival, nasal, vaginal, rectal, or transdermal) administration, etc. Parenteral administration includes, for example, intravenous administration, intramuscular administration, intraarterial administration, intradermal administration, subcutaneous administration, intraperitoneal administration, intraperitoneal administration, and intracranial administration. Other delivery modes include, but are not limited to, the use of liposomal formulations, transdermal patches, etc.

[0022] It is understood that the examples and embodiments described herein are for illustrative purposes only, and that various modifications or changes in light thereof will be suggested to those skilled in the art and are to be included within the spirit and scope of the specification and the appended claims.

[0023] IV. Description The present subject matter is directed to infusing medication directly from a vial to a patient. Consistent with the implementation of the present subject matter, a movable hanger label is provided for attaching to and supporting a vial to facilitate direct infusion of medication, such as one or more pharmaceutical, biopharmaceutical, and / or biological, from the vial to a patient.

[0024] In traditional drug infusion procedures, one or more healthcare providers may be responsible for intravenous administration, which may include, for example, a dose preparation procedure and a patient preparation procedure for delivering the drug intravenously to the patient as directed. For example, the dose preparation procedure involves one or more healthcare providers preparing a diluted drug in an intravenous bag, which consumes valuable resources of time (e.g., the healthcare provider's time to prepare the diluted drug) and materials (e.g., intravenous bags). Furthermore, the dose preparation procedure must be performed in a sterile environment, further wasting resources such as sterile equipment (e.g., healthcare provider gloves and masks) and hospital or clinical space. Furthermore, such dose preparation procedures are inherently prone to error because they rely on human interaction in preparing the diluted drug.

[0025] With regard to patient considerations, conventional drug infusion procedures typically require a significant amount of time to administer the drug to the patient. As the drug is diluted, for example with saline, the amount of fluid delivered to the patient increases, thereby increasing the time for drug administration.

[0026] A movable hanger label consistent with implementations of the present subject matter simplifies traditional medication infusion procedures by providing for infusion of medication directly from a vial to a patient, thereby reducing the time, material, and space resources associated with traditional dose preparation procedures. Additionally, using a movable hanger label for direct infusion of medication to a patient can reduce the time required for medication administration, thereby increasing the overall patient experience.

[0027] 1A-2B illustrate features of a movable hanger label 100 configured to adhere to and support a vial consistent with an implementation of the present subject matter. Fig. 1A is a planar perspective view of the movable hanger label 100, and Fig. 1B is a planar front view of the movable hanger label 100. Fig. 2A is a perspective view of the movable hanger label 100 in a curved orientation (e.g., a configuration in which the movable hanger label 100 is applied to a vial), and Fig. 2B is a perspective view of the movable hanger label 100 in a curved orientation in which the movable hanger portion 150 is in an open or loop configuration.

[0028] As shown in FIGS. 1A-2B, the movable hanger label 100 has a back region 102 and a front region 104 opposite the back region 102. The back region 102 and the front region 104 are generally planar. The movable hanger portion 150 is formed from a portion of the back region 102 and an opposite portion of the front region 104 of the movable hanger label 100 and is configured to move from a first position (e.g., a closed position or closed configuration) to a second position (e.g., an open position or open configuration). In the first position (e.g., a closed position), the movable hanger portion 150 is aligned with the remaining region of the movable hanger label 100. In the second position (e.g., an open position or loop position), the movable hanger portion 150 of the movable hanger label 100 is at least partially separated from the remaining region of the movable hanger label 100. That is, consistent with the practice of the present subject matter, the movable hanger portion 150 is a portion that may move relative to the movable hanger label 100 to form a loop or hanger 150 (as shown in FIG. 2B).

[0029] Consistent with the implementation of the present subject matter, the movable hanger label 100 is perforated such that the movable hanger portion 150 is formed from a portion of the back region 102 and an opposite portion of the front region 104 of the movable hanger label 100. The perforations 152 allow the movable hanger portion 150 to be at least partially separated from the remainder of the movable hanger label 100 so that the movable hanger portion 150 can move (along the perforations 152) relative to the movable hanger label 100, as shown in FIG. 2B . The perforations 152 define at least a portion of the periphery of the movable hanger portion 150, as shown in FIG. 2B . The movable hanger portion 150 may be peeled from the remainder of the movable hanger label 100 by grasping first and / or second extending tabs or corner or end regions of the movable hanger portion 150 and peeling the movable hanger portion 150 along the perforations 152.

[0030] The movable hanger portion 150 is fixed to the movable hanger label 100 at a fixed end 154 of the movable hanger label 100. The perforations 152 adjacent to or near the fixed end 154 may have a curved shape or the like to provide or facilitate movement (e.g., rotational movement) of the movable hanger portion 150. The curved shape of the end region of the perforations 152 can also prevent tearing at the end region of the movable hanger label 100. For example, the movable hanger portion 150 may rotate approximately 180° from a closed position to an open or looped position, and the curved shape of the end region of the perforations 152 provides for rotation of the movable hanger label 100 away from the perforations 152 without tearing or with minimal tearing.

[0031] The movable hanger label 100 suitable for implementing the present subject matter is made of a flexible material that allows it to conform to the shape of the surface to which it is applied. For example, the movable hanger label 100 may be made of a flexible plastic or reinforced paper. The movable hanger label 100 may be attached to a vial having a curved outer sidewall, and the movable hanger label 100 may substantially conform to the curvature of the outer sidewall of the vial. The movable hanger label 100 may conform to various surface shapes and is not limited to being used with cylindrical vials, but may also be used with cubic vials, for example.

[0032] The back region 102 of the movable hanger label 100 may include a binder or substance that will adhere or bond to various materials, such as glass, plastic, metal, etc. Consistent with aspects of the present subject matter, the portion of the back region 102 that forms the movable hanger portion 150 does not include a binder or substance, allowing the movable hanger portion 150 to be separated from the remainder of the movable hanger label 100 so that the movable hanger portion 150 moves between a first position (e.g., a closed position) and a second position (e.g., an open position or a loop position) when the movable hanger label 100 is attached to a vial.

[0033] 3A-3B, a side view of the movable hanger label 100 is shown when attached to a vial 300 consistent with the practice of the present subject matter. On the left side of FIG. 3A, the movable hanger label 100 is shown with the movable hanger portion 150 adhered to the vial 300 in a closed configuration (or position). On the right side of FIG. 3A, the movable hanger portion 150 is moved from the closed configuration (or position), forming a sort of hanger, to an open configuration (or position) as a result of separation and movement (e.g., rotational movement) of the movable hanger portion 150 away from the remainder of the movable hanger label 100. As shown, the movable hanger portion 150 may be in the form of a loop such that when the vial 300 is turned face-down, the loop (located at the bottom of the vial 300) faces face-up, allowing the vial 300 to be attached to or secured to a device with the top surface of the vial 300 accessible. 3B, such a configuration provides for the medication contained within vial 300 to be directly accessible from vial 300 while the vial is attached or secured (e.g., suspended) to a device. For example, with movable hanger portion 150 open, vial 300 may be secured to an infusion stand or the like, such as by having movable hanger portion 150 secured in a loop to an arm or extension of the infusion stand or the like. In a configuration in which vial 300 is supported by movable hanger portion 150 of movable hanger label 100 and vial 300 faces substantially downward, the lettering and / or markings on movable hanger label 100 may face up, right, or a combination thereof. For example, consistent with implementation of the present subject matter, the text and / or markings on the movable hanger label 100 may be inverted when the vial 300 is in an upright position, allowing the text and / or markings to be right-side up when the vial 300 is suspended and supported by the movable hanger portion 150.

[0034] With further reference to FIG. 3B, a step 350 of preparing a vial 300 having a movable hanger label 100 for administering the medication contained in the vial 300 to a patient is shown.

[0035] At 355, the vial cap is removed from the vial 300 containing the medication, thus adhering the movable hanger label 100 to the vial 300. In some examples, the vial 300 may include a stopper in its top portion, and the vial cap may be configured to cover the stopper.

[0036] At 360, the vial stopper is drilled with an infusion line spike that couples to an infusion line (not shown in FIG. 3B). In some embodiments, the infusion line spike penetrates the center or near-center of the vial stopper. In some embodiments, the longitudinal orientation of the infusion line spike is at 90° relative to the top surface of the vial stopper. In some embodiments, the longitudinal orientation of the infusion line spike is at about 80°, about 81°, about 82°, about 83°, about 84°, about 85°, about 86°, about 87°, about 88°, about 89°, about 90°, about 91°, about 92°, about 93°, about 94°, about 95°, about 96°, about 97°, about 98°, about 99°, or about 100° relative to the top surface of the vial stopper.

[0037] At 365, the infusion line spike is inserted into vial 300 through the vial stopper at a location where at least an end region of the infusion line spike is visible through vial 300. For example, the infusion line spike is inserted into vial 300 through the vial stopper until the infusion line spike is visible at the neck of vial 300, and the infusion line spike is inserted into vial 300.

[0038] At 370, the process begins with moving the movable hanger portion 150 of the movable hanger label 100 from a first position (e.g., a closed position or configuration) to a second position (e.g., an open position or configuration). In some examples, the first and / or second extending tabs or corner or end regions of the movable hanger portion 150 may be lifted or peeled away from the vial 300 and the remainder of the movable hanger label 100.

[0039] At 375, the process continues by moving the movable hanger portion 150 of the movable hanger label 100 from the first position to the second position. Consistent with practicing the present subject matter, the movable hanger portion 150 is torn and / or peeled from the movable hanger label 100 along the perforations 152 described above with reference to Figures 1A-2B.

[0040] At 380, when the movable hanger portion 150 is completely or nearly completely in the second position, such that a loop is formed and graspable, the vial 300 is inverted with the infusion line spike held within the vial. At 385, the vial 300 is attached to a device, such as an infusion stand or infusion pole, via the movable hanger portion 150. In particular, when the movable hanger portion 150 is in the open position, the movable hanger portion 150 may be secured to the infusion stand or infusion pole, such as by being looped over an arm or extension of the infusion stand or infusion pole. In this configuration, the vial 300 is supported by the movable hanger portion 150 of the movable hanger label 100 with the vial 300 facing substantially downward.

[0041] Consistent with the implementation of the present subject matter, the movable hanger portion 150 may support a vial 300 weighing up to about 500 kg. The movable hanger portion 150 may support a vial 300 weighing up to about 50 kg, about 100 kg, about 150 kg, about 200 kg, about 250 kg, about 300 kg, about 350 kg, about 400 kg, or about 450 kg. The movable hanger portion 150 may support a vial 300 weighing up to about 10 kg, about 15 kg, about 20 kg, about 25 kg, about 30 kg, about 35 kg, about 40 kg, or about 45 kg. The movable hanger portion 150 may support a vial 300 weighing up to about 1 kg, about 2 kg, about 3 kg, about 4 kg, about 5 kg, about 6 kg, about 7 kg, about 8 kg, or about 9 kg. The movable hanger portion 150 may support a weight of between about 0.5 kg and about 500 kg of vial 300. The vial weight may be any value or subrange within the cited ranges, including the endpoints.

[0042] In some embodiments, the movable hanger portion 150 may be reinforced with extra support material to resist breakage and increase support for the vial 300. In some embodiments, the movable hanger portion 150 may be made of a stronger material than the rest of the movable hanger label 100.

[0043] Furthermore, the movable hanger label 100 and the movable hanger portion 150 may be of various sizes and shapes, and are not particularly limited. For example, the total length of the movable hanger label 100 may be between about 75 mm and about 100 mm, and the total height of the movable hanger label 100 may be between about 30 mm and about 40 mm. The width of the support portion of the movable hanger portion 150 (e.g., the portion from which the vial 300 hangs when attached to the device) can be between about 5.0 mm and about 7.0 mm, e.g., about 5.0 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.6 mm, about 5.7 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.6 mm, about 6.7 mm, about 6.8 mm, about 6.9 mm, or about 7.0 mm. The thickness of the hanger label can be between about 0.05 mm and about 0.25 mm, e.g., about 0.15 mm and about 0.18 mm. Any indicated parameter may be any value or subrange within the cited range, including the endpoints.

[0044] The movable hanger label 100 and the movable hanger portion 150 are not limited to the sizes, shapes, and proportions shown in the exemplary illustrations of Figures 1A-3B. Rather, the movable hanger label 100 and the movable hanger portion 150 consistent with implementation of the present subject matter may take the form of a variety of sizes, shapes, and proportions. For example, the movable hanger label 100 and the movable hanger portion 150 may have sizes and shapes to accommodate various vials or containers.

[0045] As described herein, the movable hanger label 100 may be used to facilitate direct infusion of a medication contained in a vial to a patient. The medication contained in the vial is not diluted prior to administration, consistent with embodiments of the present subject matter. Administering the medication contained in the vial to a patient may include infusing the medication into the patient using an infusion line and an infusion pump, followed by flushing with saline, also using the infusion line and infusion pump. An infusion line spike may be placed at the proximal end of the infusion line.

[0046] FIG. 4 is a side view of an exemplary infusion line spike 410 for direct medication infusion that may be employed consistent with the practice of the present subject matter. As shown in FIG. 4, the infusion line spike 410 includes a medication port 412, an air vent cap 414, and a body 416 in fluid communication with the medication port 412. The body 416 is coupled to the infusion line 420 such that there is fluid communication from the medication port 412 to the infusion line 420 via the body 416. The infusion line spike 410, as illustrated in FIG. 4, is configured to introduce medication contained in the vial 300 into the infusion line 420. Other mechanisms may be used in place of the infusion line spike configuration. The infusion line 420 is coupled to an infusion pump (not shown), which operates to pump a fluid or material contained in the infusion line 420 at a predetermined rate. A needle (not shown) is inserted into the distal end of the infusion line 420 for delivering medication from the infusion line 420 to the patient.

[0047] Consistent with implementations of the present subject matter, a process for administering a medication utilizing the movable hanger label 100 may include infusing a first amount of saline into an infusion line. For example, the first amount of saline may be provided in a saline bag or container (e.g., containing 0.9% NaCl), and an infusion line spike (or other mechanism) may be coupled to the saline bag or container to introduce (via pumping) the first amount of saline into the infusion line. This may be done so that air is removed from the infusion line prior to infusing the medication into the patient (and prior to inserting a needle into the patient).

[0048] The process may continue by removing the vial cap from the vial containing the medication. In some examples, the vial may include a stopper in its upper portion, and the vial cap may be configured to cover the stopper. The stopper may be rubber or other resilient, compressible material to allow an infusion line spike to pierce the stopper so that it can be inserted into the vial, thereby directing the medication contained in the vial into the infusion line.

[0049] The movable hanger label 100 attached to the vial may then be released such that the movable hanger portion 150 moves from a first position (e.g., a closed configuration) to a second position (e.g., an open or loop configuration). As described herein, by moving the movable hanger portion 150 to the open or loop configuration, the vial may be attached to a device to facilitate direct infusion of a medication from the vial. For example, the vial may be suspended via the movable hanger portion 150 from an infusion stand or the like.

[0050] Once the vial is in the proper position, the air vent cap on the infusion line spike may be opened and the infusion pump may be programmed to administer the medication to the patient at the desired infusion rate and volume. When the infusion pump begins operating at the desired infusion rate, the medication travels from the vial through the infusion line spike, through the infusion line to the needle inserted into the patient at the distal end of the infusion line, and back to the needle inserted into the patient at the distal end of the infusion line.

[0051] V. Method of Administration In one aspect, a method of intravenously administering a drug to a patient is provided, which may utilize a vial having a movable hanger label as described herein, or any other vial or container suitable for this purpose.

[0052] The method includes administering a drug to a patient via intravenous administration without diluting the drug prior to administration. In embodiments, the method also includes administering saline intravenously to the patient after the drug. This saline infusion can "flush" the infusion line, reducing the amount of drug remaining in the line after administration. For drugs that are administered in small volumes (e.g., about 60 mL or less, or about 40 mL or less), the process can allow the patient to administer the entire amount of drug. The method can also reduce the total administration time (drug administration + saline flush) to the patient compared to standard administration methods.

[0053] The method may include infusing a first amount of saline (or other suitable liquid) into the infusion line. For example, the first amount of saline may be provided in a saline bag or container (e.g., containing 0.9% NaCl) and introduced (via pumping) into the infusion line. This may be done so that air is removed from the infusion line prior to infusing the medication into the patient (and prior to inserting the needle into the patient).

[0054] The medication can be administered using an infusion pump. After the infusion dose of the medication being administered to the patient is completed, a second medication can be administered to the patient using the same or similar procedure. The second medication can be the same type as the first medication administered or a different type. When the infusion dose of the medication being administered is completed or following administration of the second medication, the infusion line can be flushed with a second amount of saline. For example, once the medication dose has been dispensed, the infusion line can be transferred to a saline bag or container containing saline, e.g., 0.9% NaCl, to flush the infusion line.

[0055] Consistent with the practice of the present subject matter, less than 1.5% of the initial amount of drug may remain in the infusion line following infusion of the second amount of saline for an infusion time of up to about 30 minutes at an infusion rate of about 3 mL / min, which infusion time may include the drug administration time and the second saline flush time.

[0056] Consistent with the practice of the present subject matter, less than 5% of the initial amount of medication may remain in the infusion line following infusion of the second amount of saline for an infusion time of up to about 10 minutes at an infusion rate of about 6 mL / min. Again, the infusion time may include the medication administration time and the second saline flush time. The initial amount of medication in the vial may be less than about 30 mL.

[0057] Consistent with further implementations of the present subject matter, a step for administering a drug to a patient can include infusing a first amount of saline into the patient through an infusion line, and then infusing an infusion amount of the drug from a vial into the patient through the infusion line for a first period of time. The drugs of the present invention can be administered at a fixed dose (e.g., the same dose regardless of the patient's age and / or weight).

[0058] The initial amount of drug in the vial may be about 30 mL or less. In embodiments, the drug is not diluted prior to infusion into the patient. In some embodiments, the initial amount of drug in the vial is between about 1 mL and about 30 mL. In some embodiments, the initial amount of drug in the vial is between about 1 mL and about 20 mL. In some embodiments, the initial amount of drug in the vial is between about 1 mL and about 15 mL. In some embodiments, the initial amount of drug in the vial is between about 5 mL and about 30 mL. In some embodiments, the initial amount of drug in the vial is between about 10 mL and about 30 mL. In some embodiments, the initial amount of drug in the vial is between about 15 mL and about 30 mL. In some embodiments, the initial amount of drug in the vial is between about 5 mL and about 25 mL. In some embodiments, the initial amount of drug in the vial is between about 5 mL and about 20 mL. In some embodiments, the initial amount of drug in the vial is between about 5 mL and about 15 mL. The amounts may be any value or subrange within the cited ranges, including the endpoints.

[0059] In some embodiments, the initial amount of drug in the vial is about 30 mL, about 29 mL, about 28 mL, about 27 mL, about 26 mL, about 25 mL, about 24 mL, about 22 mL, or about 21 mL or less. In some embodiments, the initial amount of drug in the vial is about 20 mL or less. In some embodiments, the initial amount of drug in the vial is about 19 mL or less. In some embodiments, the initial amount of drug in the vial is about 18 mL or less. In some embodiments, the initial amount of drug in the vial is about 17 mL or less. In some embodiments, the initial amount of drug in the vial is about 16 mL or less. In some embodiments, the initial amount of drug in the vial is about 15 mL or less. In some embodiments, the initial amount of drug in the vial is about 14 mL or less. In some embodiments, the initial amount of drug in the vial is about 13 mL or less. In some embodiments, the initial amount of drug in the vial is about 12 mL or less. In some embodiments, the initial amount of drug in the vial is about 11 mL or less. In some embodiments, the initial amount of drug in the vial is about 10 mL or less. In some embodiments, the initial volume of drug in the vial is about 5 mL or less.

[0060] The patient may then infuse a second amount of saline through the infusion line for a second period of time. Consistent with practice of the present subject matter, less than about 10% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, less than about 9%, less than about 8%, less than about 7%, or less than about 6% of the initial amount may remain in the infusion line after infusing the second amount of saline. In some embodiments, less than about 5% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, less than about 4% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, less than about 3% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, less than about 2% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, less than about 1.5% of the original amount of drug may remain in the infusion line after the second amount of saline is infused, hi some embodiments, less than about 1% of the original amount of drug may remain in the infusion line after the second amount of saline is infused.

[0061] In some embodiments, about 0% to about 10% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, about 0% to about 5% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, about 0% to about 1.5% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, about 1% to about 5% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. In some embodiments, about 1.5% to about 5% of the initial amount of drug may remain in the infusion line after infusing the second amount of saline. The amounts may be any value or subrange within the cited ranges, including the endpoints.

[0062] The sum of the first period (time for infusing the drug) and the second period (time for flushing the saline solution) may be about 60 minutes or less, about 30 minutes or less, or about 15 minutes or less.

[0063] In embodiments, the total may be between about 5 minutes and about 60 minutes. In embodiments, the total may be between about 5 minutes and about 45 minutes. In embodiments, the total may be between about 10 minutes and about 45 minutes. In embodiments, the total may be between about 10 minutes and about 30 minutes. In embodiments, the total may be between about 15 minutes and about 30 minutes. In embodiments, the total may be between about 5 minutes and about 25 minutes. In embodiments, the total may be between about 5 minutes and about 20 minutes. The amount of time may be any value or subrange within the cited ranges, including the endpoints.

[0064] The infusion volume of the drug may be between about 10 mL and about 30 mL, and the second volume of saline may be between about 25 mL and about 90 mL.

[0065] In embodiments, the second amount of saline may be between about 20 mL and about 100 mL. In embodiments, the second amount of saline may be between about 25 mL and about 90 mL. In embodiments, the second amount of saline may be between about 25 mL and about 80 mL. In embodiments, the second amount of saline may be between about 25 mL and about 70 mL. In embodiments, the second amount of saline may be between about 25 mL and about 60 mL. In embodiments, the second amount of saline may be between about 25 mL and about 50 mL. In embodiments, the second amount of saline may be between about 25 mL and about 40 mL. In embodiments, the second amount of saline may be between about 25 mL and about 30 mL. The amounts may be any value or subrange within the cited ranges, including the endpoints.

[0066] The drug and / or the second amount of saline may be infused into the patient at an infusion rate of between about 1 mL / min and about 10 mL / min. The drug and / or the second amount of saline may be infused into the patient at an infusion rate of between about 2 mL / min and about 10 mL / min. The drug and / or the second amount of saline may be infused into the patient at an infusion rate of between about 3 mL / min and about 10 mL / min. The drug and / or the second amount of saline may be infused into the patient at an infusion rate of between about 1 mL / min and about 8 mL / min. The drug and / or the second amount of saline may be infused into the patient at an infusion rate of between about 1 mL / min and about 6 mL / min. The drug and / or the second amount of saline may be infused into the patient at an infusion rate of about 1 mL / min. The drug and / or the second amount of saline may be infused into the patient at an infusion rate of about 2 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 3 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 4 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 5 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 6 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 7 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 8 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 9 mL / min. The agent and / or the second amount of saline may be infused into the patient at an infusion rate of about 10 mL / min. The amounts may be any value or subrange within the cited ranges, including the endpoints. [Example]

[0067] Example 1: Rapid, Ready-to-Infuse (RRTI) Atezolizumab The direct infusion of Tecentriq®, a cancer immunotherapy drug, atezolizumab, can simplify administration preparation and enable rapid infusion (e.g., 10 minutes for intravenous infusion), improving the healthcare professional and patient experience.

[0068] The intravenous RRTI approach simplifies healthcare professionals' workflow by allowing them to administer the medication directly from the primary packaging (e.g., vial). Rapid infusion of the medication (e.g., 10-minute infusion time) can further improve patient outcomes. Therefore, Tecentriq® is a good candidate for RRTI because it is a liquid formulation (no need for reconstitution) and comes in a single-dose dosage.

[0069] The following protocol is an example of how to rapidly infuse a liquid medication, such as atezolizumab, from a vial. First, prime the infusion line with normal saline (e.g., 0.9% NaCl) before insertion. Remove the vial cap and pierce the center of the rubber stopper with the infusion spike. Figure 4 shows the infusion line spike alone (top) and after insertion into the vial (bottom). Ensure that the medication port is resting in the neck area of ​​the vial near the stopper, as shown at the bottom of Figure 4. Open the hanger label and hang the vial upside down on an IV stand. Open the infusion line's air vent cap, set the infusion rate and volume (VTBI) according to Table 1, and begin the infusion. For example, for 1680 mg, set the VTBI to 14.0 mL and begin the infusion. Once the infusion is complete, open another 15 cc vial and repeat the protocol. Set the VTBI to 14.0 mL and begin the infusion. Once the desired dose has been dispensed, move the infusion line to a container containing 0.9% NaCl to flush the line and set the infusion rate and VTBI according to Table 1.

[0070] Atezolizumab is available in three doses (840 mg, 1200 mg, and 1680 mg) depending on the indication and protocol used. Currently, atezolizumab is diluted in a 250 mL infusion bag containing 0.9% Sodium Chloride Injection, USP, prior to administration. The initial infusion of atezolizumab is administered intravenously over 60 minutes. If the initial infusion is tolerated, all subsequent infusions may be administered over 30 minutes or longer. TECENTRIQ® (atezolizumab) Prescribing Information, www.gene.com / download / pdf / tecentriq_prescribing.pdf.

[0071] The rapid and immediate infusion methods for atezolizumab described herein were tested. A total of six infusion scenarios were evaluated. Two infusion times were evaluated: 30 minutes for the initial dose and 10 minutes for subsequent doses. Three infusion times were evaluated: 840 mg, 1200 mg, and 1680 mg. To simplify the process for end users, it is proposed to use the same infusion rate for all three tested doses with the same infusion time. This evaluation tested a rate of 3 mL / min for the initial dose infusion over the first 30 minutes, followed by a rate of 6 mL / min for the subsequent 10 minutes of dose infusion. Table 1 shows the VTBI for the three doses and two infusions.

[0072] TIFF0007796651000001.tif41170

[0073] 5A and 5B are graphs 500 and 550, respectively, of atezolizumab concentration as a function of time for two scenarios. Scenario 1, shown in FIG. 5A, is an 840 mg dose of atezolizumab infused over 30 minutes. Scenario 1, shown in FIG. 5B, is an 840 mg dose of atezolizumab infused over 10 minutes. The atezolizumab concentrations are measured from the end of the infusion line and are the concentrations a patient would expect to experience.

[0074] 6A and 6B are graphs 600 and 650, respectively, of atezolizumab concentration as a function of time for two scenarios. Scenario 3, shown in FIG. 6A, is a 1200 mg dose of atezolizumab infused over 30 minutes. Scenario 4, shown in FIG. 6B, is a 1200 mg dose of atezolizumab infused over 10 minutes. The atezolizumab concentrations are measured from the end of the infusion line and are the concentrations a patient would expect to experience.

[0075] 7A and 7B are graphs 700 and 750, respectively, of atezolizumab concentration as a function of time for two scenarios. Scenario 5, shown in FIG. 7A, is a 1680 mg dose of atezolizumab infused over 30 minutes. Scenario 6, shown in FIG. 7B, is a 1680 mg dose of atezolizumab infused over 10 minutes. The atezolizumab concentrations are measured from the end of the infusion line and are the concentrations a patient would expect to experience.

[0076] Table 2 below provides an overview of the six simulated infusion and saline flush scenarios that were evaluated. The maximum atezolizumab concentration (Cmax) during the infusion and saline flush ranged from 43.0 mg / mL to 57.1 mg / mL. The residual atezolizumab in the infusion line after infusion (i.e., underdosage) ranged from 0.5 to 4.8%. Underdosage due to atezolizumab remaining in the infusion line also applies to the current infusion bag setup and is not a risk specific to RRTIs.

[0077] TIFF0007796651000002.tif51170

[0078] Example 2: Stress test Hanger label load tests were conducted in accordance with or in accordance with DIN ISO 15137 (Requirements and test methods for self-adhesive hanging devices for infusion bottles and injection vials; available on the ISO website at www.iso.org / standard / 37391.html; incorporated herein by reference in its entirety). Permanent load tests were conducted for 24 hours with a 500g load, similar to DIN ISO 15137. Short-term load tests were conducted in accordance with / similar to DIN ISO 15137 with a 1kg conforming weight for 30 seconds. Hanger labels either meet or fail to meet the requirements based on these tests.

[0079] It should be understood that the disclosures, including the figures, set forth herein may describe and / or illustrate different variations separately, but may also combine all or some or their components.

[0080] Although various exemplary embodiments have been described above, any number of modifications may be made to the various embodiments. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of various device and system embodiments may be included in some embodiments and not in other embodiments. Accordingly, the above description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the claims.

[0081] As used herein, when a feature or element is referred to as "on" another feature or element, it may be directly on the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it will be understood that it may be directly connected, attached, or coupled to the other feature or element, or that intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, features and elements so described or illustrated may also be applicable to other embodiments. A reference to a structure or feature being located "adjacent" to another feature may have overlapping or underlying portions with the adjacent feature.

[0082] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting. For example, as used herein, the singular forms "an," "an," and "the" are intended to include the plural unless the context clearly dictates otherwise. It should be further understood that, as used herein, the terms "comprises" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0083] Spatial relative terms, such as "below," "below," "lower," "above," "above," and the like, may be used herein for ease of description to describe the relationship of one element or feature to another, as shown in the figures. It should be understood that spatial relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures were inverted, an element described as "below" or "below" the other element or feature would then be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an upward and downward orientation. The device may be otherwise oriented (e.g., rotated 90 degrees or at another orientation), and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless otherwise noted.

[0084] In this specification, the terms "first" and "second" may be used to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element described below may be referred to as a second feature / element, and similarly, a second feature / element described below may be referred to as a first feature / element without departing from the teachings provided herein.

[0085] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprises," and variations of "comprises" and "comprising," mean that various components may be employed conjugatively in methods and articles (e.g., compositions and apparatuses that include devices and methods). For example, the term "comprising" should be understood to mean the inclusion of any recited element or step, but not the exclusion of other elements or steps.

[0086] As used herein in the specification and claims, including those used in the examples, unless expressly specified otherwise, all numbers can be read as if they begin with the word "about" or "approximately," even if that term is not explicitly indicated. The phrase "about" or "approximately" is used when describing a size and / or location and may be used to indicate that the described numerical value and / or location is within a reasonably expected range of values ​​and / or locations. For example, a numerical value may have a value of ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. In embodiments, "about" refers to ±10% or less of the stated value (or range of values). Additionally, numerical values ​​described herein should be understood to include values ​​at or about that value unless the context indicates otherwise.

[0087] The examples and illustrations contained herein are for purposes of illustration, not limitation, and show specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. While specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, are possible.

[0088] In the above description and in the claims, phrases such as "at least one" or "one or more" may appear following a conjunction list of elements or features. The term "and / or" may also occur with a list of two or more elements or features. Unless implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to refer to any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A alone, B alone, or A and B together," respectively. A similar interpretation is intended for lists containing more than two items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together," respectively. Use of the term "based on" above and in the claims is intended to mean "based at least in part on," allowing for unrecited features or elements.

[0089] The embodiments set forth in the foregoing description do not represent all embodiments consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. While some variations have been described in detail herein, other modifications or additions are possible. In particular, further features and / or variations may be provided in addition to those described herein. For example, the above-described embodiments may be directed to various combinations and subcombinations of the disclosed features and / or further combinations and subcombinations of one or more of the features disclosed herein. Furthermore, the logical flow depicted in the accompanying figures and / or described herein does not necessarily require the particular order shown, or sequential order, to achieve desirable results. The following claims may encompass other implementations or embodiments.

Claims

1. 1. An apparatus comprising: Equipped with a label, The label is a back surface region; a front region opposite the back region; a portion of the back region of the label and an opposite portion of the front region of the label include a movable hanger, the movable hanger configured to move from a first position to a second position; In the first position, the movable hanger is at least substantially aligned with a remainder of the back area and an opposite remainder of the front area; In the second position, the movable hanger is at least partially separated from the remaining portion of the back area and the remaining portion of the opposite side of the front area, the label is attached to the vial, and the movable hanger in the second position is configured to support a weight of up to 10 kg of the vial from an infusion stand; The portion of the label that constitutes the movable hanger is reinforced with a supporting material that is not present in the portion of the label that does not constitute the movable hanger, or is made of a stronger material than the portion of the label that does not constitute the movable hanger.

2. 10. The device of claim 1, wherein the remaining portion of the back surface area of ​​the label is configured to adhere to an exterior sidewall of the vial.

3. The device of claim 1 or claim 2, wherein the label comprises a flexible material.

4. 4. The device of claim 1, wherein the rear region includes the portion of the rear region and the remaining portion of the rear region, and the front region includes the opposite portion of the front region and the remaining portion of the opposite side of the front region.

5. 5. The apparatus of claim 1, wherein the label further includes perforations extending through the back region and the front region, the perforations further defining at least a portion of a perimeter of the movable hanger.

6. The device of claim 5 , wherein the perforations are configured to at least partially separate the movable hanger from the remainder of the back region and the opposite remainder of the front region.

7. The apparatus of claim 5 , wherein the movable hanger is configured to move from the first position to the second position along the perforation.

8. The apparatus of claim 1 , wherein the movable hanger in the second position is in a loop configuration, the loop configuration including a first fixed end and a second fixed end.

9. 9. The device of claim 8, wherein the movable hanger in the first position includes a portion extending in a first direction from the first fixed end to a first corner, a portion extending in the first direction from the second fixed end to a second corner, and a portion extending in a second direction perpendicular to the first direction to connect the first corner and the second corner.

10. 10. The device of claim 1, wherein the movable hanger in the second position is positioned so that the vial hangs substantially downwardly from the infusion stand.

11. 11. The device of claim 10, wherein the label includes text on the front area, and when the vial is substantially sagged downward, the text is upside down, right side up, or a combination thereof.

12. 12. The apparatus of claim 1, wherein the movable hanger in the second position is configured to support a weight of the vial of up to 500 kg.

13. 13. The device of any one of claims 1 to 12, wherein the length of the label is between 75mm and 100mm.

14. 14. The device of any one of claims 1 to 13, wherein the height of the label is between 30mm and 40mm.

15. 15. The device of any one of claims 1 to 14, wherein the width of the movable hanger is between 5mm and 7mm.

Images