Systems and methods for monitoring a medicament dosing schedule

Abstract

A non-transitory computer readable storage medium, user device and method configured to execute a program for managing a user's medical condition or treatment. When the program determines that a time period for taking a scheduled dose has been exceeded by more than a lower threshold time, it causes a late dose notification to be displayed. When a user interacts with the late dose notification, the program provides options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose. When the user indicates that they have taken the scheduled dose after the lower threshold time, the program provides options for the user to (i) reset the current medicament dosing schedule or (ii) maintain the current medicament dosing schedule.

Description

[0001] SYSTEMS AND METHODS FOR MONITORING A MEDICAMENT DOSING SCHEDULE

[0002] Field

[0003] The present specification relates to systems and methods for monitoring a current medicament dosing schedule and, in particular, to a computer implemented system and method for determining when a user is late with a scheduled dose and providing after dose options to maintain or reset the medicament dosing schedule.

[0004] Background

[0005] A significant barrier to high quality therapeutic outcomes is patient engagement and adherence with a prescribed medication regimen as well as patient understanding of the factors affecting their disease progression and overall health.

[0006] In particular, some medications are prescribed for self-dosing and have a prescribed dosing frequency. Patients are required to monitor their medicament dosing schedule and to take their doses as prescribed in order to achieve the best therapeutic outcomes. If a patient is late taking a dose, then they may not know what the best course of action is. Guidance exists for the recommended course of action when a patient is late taking a dose and this guidance may depend on the prescribed dosing frequency and the amount to which the patient is late taking the dose.

[0007] Current systems do not effectively allow patients to access guidance on how to handle missed or late doses in a convenient and timely manner. Current system also do not provide the most effect reminder and notification systems for patients in relation to their prescribed medication regimen, or provide the required adaptability in such systems to accommodate specific missed dose guidance for a medicament. There is therefore a need for systems and methods to provide effective reminders and notifications to patients in relation to a prescribed dosing regimen and convenient and timely guidance to patients when they are late taking a prescribed dose, which can lead to an improvement in patient engagement and adherence, and ultimately to improved therapeutic outcomes for the patient. Summary

[0008] A first aspect of this specification provides a non-transitory computer readable storage medium comprising instructions that, when executed by a computing device, cause the computing device to: execute a program for managing a user’s medical condition or treatment; monitor a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determine that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, provide options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program.

[0009] Determining that a time period for taking a scheduled dose has been exceeded may comprise determining that the program has not received a user input indicating that a dose has been taken when the time period ends.

[0010] The late dose notification may be displayed as a push notification on the lock screen or home screen of the computing device.

[0011] Providing options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose may comprise displaying a first selectable user interface icon and a second selectable user interface icon.

[0012] The options for the user to indicate that they have not taken the scheduled dose may comprise an option to begin a guided dosing process and an option to set a reminder to perform the dosing process at a later time. The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to receiving a user selection of the option to begin the guided dosing process, begin display of a step-by-step selfdosing guide. The instructions may be further configured, when executed by the computing device, to cause the computing device to, when it is detected that the user indicates that they have taken the scheduled dose: provide a user interface for specifying the date and time that the dose was taken; and provide a user interface for specifying a body location into which the dose was injected or infused.

[0013] When it is detected that the user selects the option to re-set the medicament dosing schedule, the instructions may be further configured, when executed by the computing device, to cause the computing device to provide a schedule re-set screen informing the user of the day of the next scheduled dose, the schedule re-set screen configured to allow the user to set a time to be reminded on the day of the next scheduled dose. The schedule re-set screen may be further configured to allow the user to specify whether they want to review a step-by-step dosing guide at the time of the next scheduled dose.

[0014] The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to determining that the time period for taking the scheduled dose has been exceeded by more than an upper threshold time, display the late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the upper threshold time, displaying a dosing re-set information screen informing the user that the medicament dosing schedule will be re-set. The upper threshold time may be equal to the dosing frequency.

[0015] The dosing frequency may be one of 7 days, 14 days or 28 days. The late dose notification may recommend that the user waits until their next scheduled dose. The dosing frequency may be 14 days and the lower threshold time may be 7 days.

[0016] The late dose notification may recommend that the user takes their next scheduled dose. The dosing frequency may be 7 days and lower threshold time may be 1 day.

[0017] The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to determining that the time period for taking the scheduled dose has been exceeded by less than the lower threshold amount, display a missed dose notification alerting the user to a missed dose; in response to detecting user interaction with the missed dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose before the lower threshold time, maintain the current medicament dosing schedule.

[0018] A second aspect of this specification provides a user device comprising processing circuitry configured to: execute a program for managing a user’s medical condition or treatment; monitor a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determine that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, provide options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program.

[0019] A third aspect of this specification provides a computer implemented method, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determining that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, displaying a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, providing options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, providing options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program.

[0020] A fourth aspect of this specification provides non-transitory computer readable storage medium comprising instructions that, when executed by a computing device, cause the computing device to: execute a program for managing a user’s medical condition or treatment; monitor a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determine that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, displaying a dosing re-set information screen informing the user that the medicament dosing schedule will be re-set.

[0021] The late dose notification of the fourth aspect may recommends that the user takes their next scheduled dose. The dosing frequency may be 28 days and lower threshold time may be 7 days.

[0022] Various embodiments described herein may be used to treat a a subject exhibiting at least one symptom of, or determined to be susceptible to, an anti-interleukin-4 receptor alpha (IL-4Ra)- related disorder, wherein the anti-IL-4Ra antibody comprises: a variable heavy chain CDR1 of SEQ ID NO:1 (GFTFRDYA); a variable heavy chain CDR2 of SEQ ID NO:2 (ISGSGGNT); a variable heavy chain CDR3 of SEQ ID NO:3 (AKDRLSITIRPRYYGLDV); a variable light chain CDR1 of SEQ ID NO:4 (QSLLYSIGYNY); a variable light chain CDR2 of SEQ ID NO:5 (LGS); and a variable light chain CDR3 of SEQ ID NO:6 (MQALQTPYT).

[0023] In some instances, the anti-IL-4Ra antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 13 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO:14.

[0024] In some instances, the IL-4Ra-related disorder is asthma. In some instances, the IL-4Ra-related disorder is a nasal-related disorder. In some instances, the nasal-related disorder is nasal polyposis. In some instances, the nasal-related disorder is sinusitis. In some instances, the nasal-related disorder is rhinitis.

[0025] In some instances, the IL-4Ra-related disorder is an esophageal-related disorder. In some instances, the esophageal-related indication is eosinophilic esophagitis.

[0026] In some instances, the IL-4Ra-related disorder is a skin-related indication. In some instances, the skin-related disorder is selected from atopic dermatitis, urticaria, infections of the skin, prurigo nodularis, bullous pemphigoid, or a combination thereof.

[0027] In some instances, the IL-4Ra-related disorder is a gastrointestinal-related disorder.

[0028] Another aspect of the specification provides a computer implemented method of treating a subject with an anti-interleukin-4 receptor alpha (anti-IL-4Ra) antibody, comprising providing guidance on administering a therapeutically effective amount of an anti-IL-4Ra antibody to a subject, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determining that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, displaying a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, providing options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, providing options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program, wherein the anti-IL-4Ra antibody comprises: a variable heavy chain CDR1 of SEQ ID NO:1 (GFTFRDYA); a variable heavy chain CDR2 of SEQ ID NO:2 (ISGSGGNT); a variable heavy chain CDR3 of SEQ ID NO:3 (AKDRLSITIRPRYYGLDV); a variable light chain CDR1 of SEQ ID NO:4 (QSLLYSIGYNY); a variable light chain CDR2 of SEQ ID NO:5 (LGS); and a variable light chain CDR3 of SEQ ID NO:6 (MQALQTPYT). In some aspects, the anti-IL-4Ra antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 13 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO:14.

[0029] In various aspects, the dosing frequency is one of 7 days, 14 days or 28 days.

[0030] In various aspects, the late dose notification recommends that the user waits until their next scheduled dose.

[0031] In various aspects, the dosing frequency is 14 days and the lower threshold time is 7 days.

[0032] In various aspects, the late dose notification recommends that the user takes their next scheduled dose.

[0033] In various aspects, the dosing frequency is 7 days and lower threshold time is 1 day.

[0034] In some aspects the specification provides a computer implemented method of treating a subject with an anti-interleukin-4 receptor alpha (anti-IL-4Ra) antibody, comprising providing guidance on administering a therapeutically effective amount of an anti-IL-4Ra antibody to a subject, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determining that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, displaying a dosing re-set information screen informing the user that the medicament dosing schedule will be re-set, wherein the anti-IL-4Ra antibody comprises: a variable heavy chain CDR1 of SEQ ID NO:1 (GFTFRDYA); a variable heavy chain CDR2 of SEQ ID NO:2 (ISGSGGNT); a variable heavy chain CDR3 of SEQ ID NO:3 (AKDRLSITIRPRYYGLDV); a variable light chain CDR1 of SEQ ID NO:4 (QSLLYSIGYNY); a variable light chain CDR2 of SEQ ID NO:5 (LGS); and a variable light chain CDR3 of SEQ ID NO:6 (MQALQTPYT).

[0035] In some aspects, the late dose notification recommends that the user takes their next scheduled dose.

[0036] In some aspects, the dosing frequency is 28 days and lower threshold time is 7 days.

[0037] In some aspects, the administering is via a pre-filled syringe.

[0038] In some aspects, the administering is via a pre-filled pen.

[0039] In some aspects, the administering is via an autoinjector.

[0040] In some aspects, the anti-IL-4Ra antibody is administered to the subject as an initial dose followed by one or more secondary doses.

[0041] In some aspects, the initial dose is about 600 mg and each secondary dose is about 300 mg.

[0042] In some aspects, the initial dose is about 400 mg and each secondary dose is about 200 mg.

[0043] In some aspects, each secondary dose is administered every 2 weeks.

[0044] In some aspects, the anti-IL-4Ra antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 13 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO:14.

[0045] In some aspects, in response to the late dose notification, the user self-administers a therapeutically effective amount of an anti-IL-4Ra antibody.

[0046] Brief Description of the Figures

[0047] So that the general concepts set out in the foregoing sections can be more fully understood, embodiments thereof will be described with reference to the accompanying drawings, in which:

[0048] Figure 1 shows an overall architecture of a system in which an application operates;

[0049] Figure 2 shows a flow chart illustrating steps performed by the application for monitoring a medicament dosing schedule; Figures 3a to 3g show exemplary screenshots displayed by the application relating to notifications displayed to the user and post-dosing actions;

[0050] Figures 4a to 4f show exemplary screenshots displayed by the application relating to further notifications and options for subsequent actions;

[0051] Figures 5a and 5b show exemplary screenshots displayed by the application relating to postdosing notifications;

[0052] Figure 6 shows an exemplary screenshot displayed by the application relating to a late dose notification;

[0053] Figure 7 shows a flow chart illustrating steps performed by the application for monitoring a medicament dosing schedule in a first exemplary mode;

[0054] Figure 8 shows a flow chart illustrating steps performed by the application for monitoring a medicament dosing schedule in a second exemplary mode;

[0055] Figure 9 shows a flow chart illustrating steps performed by the application for monitoring a medicament dosing schedule in a third exemplary mode; and

[0056] Figure 10 illustrates schematically a user device according to some embodiments.

[0057] Detailed description

[0058] The present disclosure relates to an application which can be run on a user device and which assists a user by notifying them of missed or late doses, providing a proactive version of guidelines for handling late doses of medicament, and allowing the user some control over their dosing schedule when a dose is taken late. The application also assists a user in adhering to their prescribed medication regimen, by providing timely encouragement and warning notifications and clearly communicating subsequent options after a dose is missed or taken late.

[0059] The application can be used to manage a broad range of diseases which are treated by a range of different medicaments. Although some of the specific embodiments below are described in relation to the treatment of atopic dermatitis and / or asthma using a single medicament, the application is not so limited. Various other immunology-related or other indications may also be managed by the application, where one or more of these indications may be treated by using a single medicament approved for use in treating the one or more indications. Such a single medicament can include, for example, different dosages containing the same API, different volumes or concentrations of the same API, or different formulations containing the same API. In some embodiments, a single medicament can include an anti IL-4R mAb (e.g., Dupilumab). Further, a broad range of immunological or other conditions may be managed by the application. The user may be prescribed one or more drugs and the application provides personalized support for users depending on their particular drug prescription(s) and health profile. For example, the application may be configured to provide support for a number of diseases caused by Type 2 inflammation. In the context of dermatology this may include Atopic Dermatitis, Prurigo Nodularis, Bullous Pemphigoid, an Urticaria (e.g., chronic spontaneous urticaria, or cold inducible urticaria), Hand and Foot Disease, or Pruritis, each of which may be treated by injections of Dupixent® or other injectable drugs, but also by some oral and topical medications. In the context of respiratory diseases, this may include Asthma, Nasal Polyps, Sinusitis (e.g., chronic sinusitis with or without nasal polyps), Allergic Bronchopulmonary Aspergillosis (ABPA), or Allergic Fungal Rhinosinusitis (AFRS) (which may be treated by injections of Dupixent® or other injectable drugs but also by some oral medications and Chronic Obstructive Pulmonary Disease (COPD, which may be treated by injections of Dupixent® or other injectable drugs). In the context of Gastroenterology this may include Inflammatory Bowel Disease (IBD) and Eosinophilic Esophagitis (EoE), Eosinophilic Gastroenteritis (EGE), or Ulcerative Colitis, which may be treated by injections of Dupixent® or other injectable drugs but also by some oral medications.

[0060] TABLE 1

[0061] Anti-IL-4Ra antibody (e.g., dupilumab) CDR amino acid sequences.

[0062] SEQ ID NO: Description Sequence

[0063] SEQ ID NO:1 HC CDR1 GFTFRDYA SEQ ID NO:2 HC CDR2 ISGSGGNT SEQ ID NO: 3 HC CDR3 AKDRLSITIRPRYYGLDV SEQ ID NOT LC CDR1 QSLLYSIGYNY SEQ ID NO:5 LC CDR2 LGS

[0064] SEQ ID NO: 6 LC CDR3 MQALQTPYT

[0065] TABLE 2

[0066] Anti-IL-4Ra antibody (e.g., dupilumab) CDR nucleotide sequences.

[0067] SEQ ID NO: Description Sequence

[0068] SEQ ID NO:7 HC CDR1 ggattcacct ttagagacta tgcc

[0069] SEQ ID NO: 8 HC CDR2 attagtggtt ccggtggtaa caca

[0070] SEQ ID NO: 9 HC CDR3 gcgaaagatc gactctctat aacaattcgc ccacgctatt atggtttgga cgtc

[0071] SEQ ID NOTO LC CDR1 cagagcctcc tgtatagtat tggatacaac tat

[0072] SEQ ID NO: 11 LC CDR2 ttgggttct TABLE 1

[0073] SEQ ID NO: 12 LC CDR3 atgcaagctc tacaaactcc gtacact

[0074] TABLE 3

[0075] Anti-IL-4Ra antibody (e.g., dupilumab) heavy and light chain variable region amino acid sequences.

[0076] SEQ ID NO: Description Sequence

[0077] SEQ ID NO: 13 Heavy chain EVQLVESGGGLEQPGGSLRLSCAGS variable GFTFRDYAMTWVRQAPGKGLEWV region SSISGSGGNTYYADSVKGRFTISRDN

[0078] SKNTLYLQMNSLRAEDTAVYYCAK

[0079] DRLSITIRPRYYGLDVWGQGTTVTV

[0080] S

[0081] SEQ ID NO: 14 Light chain DIVMTQSPLSLPVTPGEPASISCRSSQ variable SLLYSIGYNYLDWYLQKSGQSPQLLI region YLGSNRASGVPDRFSGSGSGTDFTLK

[0082] ISRVEAEDVGFYYCMQALQTPYTFG

[0083] QGTKLEIK

[0084] TABLE 4

[0085] Anti-IL-4Ra antibody (e.g., dupilumab) heavy and light chain variable region nucleotide sequences.

[0086] SEQ ID NO: Description Sequence

[0087] SEQ ID NO: Heavy gaggtgcagc tggtggagtc tgggggaggc ttggaacagc 15 chain cgggggggtc cctgagactc tcctgtgcag gctctggatt variable cacctttaga gactatgcca tgacctgggt ccgccaggct region ccagggaagg gactggagtg ggtctcatct attagtggtt ccggtggtaa cacatactac gcagactccg tgaagggccg gttcaccatc tccagagaca attccaagaa cacgctgtat ctgcaaatga acagcctgag agccgaggac acggccgtat attactgtgc gaaagatcga ctctctataa caattcgccc acgctattat ggtttggacg tctggggcca agggaccacg gtcaccgtct cc

[0088] SEQ ID NO: Light gacatcgtga tgacccagtc tccactctcc ctgcccgtca

[0089] 16 chain cccctggaga gccggcctcc atctcctgca ggtctagtca variable gagcctcctg tatagtattg gatacaacta tttggattgg region tacctgcaga agtcagggca gtctccacag ctccttatct atttgggttc taatcgggcc tccggggtcc ctgacaggtt TABLE 4 cagtggcagt ggatcaggca cagattttac actgaaaatc agcagagtgg aggctgagga tgttgggttt tattactgca tgcaagctct acaaactccg tacacttttg gccaggggac caagctggag atcaaa

[0090] TABLE 5

[0091] Anti-IL-4Ra antibody (e.g., dupilumab) heavy and light chain constant amino acid sequences.

[0092] SEQ ID NO: Description Sequence

[0093] SEQ ID NO: 17 Heavy Chain EVQLVESGGGLEQPGGSLRLSCAGSG

[0094] FTFRDYAMTWVRQAPGKGLEWVSSI

[0095] SGSGGNTYYADSVKGRFTISRDNSKN

[0096] TLYLQMNSLRAEDTAVYYCAKDRLS

[0097] ITIRPRYYGLDVWGQGTTVTVSSAST

[0098] KGPSVFPLAPCSRSTSESTAALGCLVK

[0099] DYFPEPVTVSWNSGALTSGVHTFPAV

[0100] LQSSGLYSLSSWTVPSSSLGTKTYTCN

[0101] VDHKPSNTKVDKRVESKYGPPCPPCP

[0102] APEFLGGPSVFLFPPKPKDTLMISRTPE

[0103] VTCVVVDVSQEDPEVQFNWYVDGVE

[0104] VHNAKTKPREEQFNSTYRVVSVLTVL

[0105] HQDWLNGKEYKCKVSNKGLPSSIEKT

[0106] ISKAKGQPREPQVYTLPPSQEEMTKN

[0107] QVSLTCLVKGFYPSDIAVEWESNGQP

[0108] ENNYKTTPPVLDSDGSFFLYSRLTVD

[0109] KSRWQEGNVFSCSVMHEALHNHYTQ

[0110] KSLSLSLG

[0111] SEQ ID NO: 18 Light Chain DIVMTQSPLSLPVTPGEPASISCRSSQSL

[0112] LYSIGYNYLDWYLQKSGQSPQLLIYLG

[0113] SNRASGVPDRFSGSGSGTDFTLKISRVE

[0114] AEDVGFYYCMQALQTPYTFGQGTKLE

[0115] IKRTVAAPSVFIFPPSDEQLKSGTASVV

[0116] CLLNNFYPREAKVQWKVDNALQSGNS

[0117] QESVTEQDSKDSTYSLSSTLTLSKADY

[0118] EKHKVYACEVTHQGLSSPVTKSFNRG

[0119] EC

[0120] TABLE 6

[0121] Human interleukin-4 receptor. TABLE 6

[0122] SEQ ID NO: Description Sequence

[0123] SEQ ID NO: Human MKVLQEPTCVSDYMSISTCEWKMNGP

[0124] 19 IL-4R TNCSTELRLLYQLVFLLSEAHTCIPENN

[0125] GGAGCVCHLLMDDVVSADNYTLDLW AGQQLLWKGSFKPSEHVKPRAPGNLT VHTNVSDTLLLTWSNPYPPDNYLYNH LTYAVNIWSENDPADFRIYNVTYLEPS LRIAASTLKSGISYRARVRAWAQCYNT TWSEWSPSTKWHNSYREPFEQH

[0126] Pharmaceutical Compositions:

[0127] The present disclosure provides methods that include administering an anti-IL-4Ra antibody, such as dupilumab to a subject, wherein the antibody is an ingredient in a pharmaceutical composition. Useful pharmaceutical compositions can be formulated with suitable carriers, excipients, and other agents that provide suitable transfer, delivery, tolerance, and the like.

[0128] Administration:

[0129] Therapeutic compositions can be administered with suitable carriers, excipients, and other agents that are incorporated into formulations to provide improved transfer, delivery, tolerance, and the like.

[0130] Dosage:

[0131] In some instances, one or more (e.g., 1 , 2, 3, 4, or 5) doses are administered at the beginning of the treatment regimen as “loading doses” followed by subsequent doses that are administered on a less frequent basis (e.g., “maintenance doses”). For example, an IL-4R antagonist may be administered to a subject at a loading dose of about 200 mg, 400 mg, or about 600 mg followed by one or more maintenance doses of about 75 mg to about 300 mg. In one embodiment, the initial dose and the one or more secondary doses each include 50 mg to 600 mg of the IL-4R antagonist, e.g., 100 mg, 150 mg, 200 mg, 250 mg, 300 mg, 400 mg, 500 mg, or 600 mg of the IL-4R antagonist. In some embodiments, the initial dose and the one or more secondary doses each contain the same amount of the IL-4R antagonist. In other embodiments, the initial dose comprises a first amount of the IL-4R antagonist, and the one or more secondary doses each comprise a second amount of the IL-4R antagonist. For example, the first amount of the IL-4R antagonist can be 1 .5x, 2x, 2.5x, 3x, 3.5x, 4x or 5x or more than the second amount of the IL-4R antagonist. In one exemplary embodiment, for a subject having a body weight that is <30 kg (e.g., >15 kg to <30 kg), an IL-4R antagonist is administered to a subject at a loading dose of about 200 mg followed by one or more maintenance doses of about 100 mg, or at a loading dose of about 600 mg followed by one or more maintenance doses of about 300 mg. In another exemplary embodiment, for a subject having a body weight that is >30 kg (e.g., >30 kg to <60 kg), an IL-4R antagonist may be administered to a subject at a loading dose of about 400 mg followed by one or more maintenance doses of about 200 mg, or at a loading dose of about 600 mg followed by one or more maintenance doses of about 300 mg. In yet another exemplary embodiment, for a subject having a body weight that is >60 kg, an IL-4R antagonist may be administered to a subject at a loading dose of about 600 mg followed by one or more maintenance doses of about 300 mg.

[0132] In some instances, administration is one initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week. In some instances, administration is via a pre-filled syringe. In some instances, administration is via a pre-filled pen. In some instances, administration is via an autoinjector. In some aspects, administration is via injection of 300 mg diluted in a 2 ml solution in a single-dose pre-filled syringe with needle shield. In some aspects, administration is one initial dose of 400 mg (two 200 mg injections in different injection sites), followed by 200 mg given every other week. In some aspects, administration is via injection of 200 mg diluted in a 1.14 ml solution in a single-dose pre-filled syringe with needle shield. In some aspects, administration is via injection of 300 mg diluted in a 2 ml solution in a single-dose pre-filled syringe.

[0133] Referring to Figure 1 , schematic overview of an overall architecture 100 for a disease management and medication regimen management system is shown. The system architecture 100 illustrates a number of functional modules and the data links between these. The system architecture 100 comprises a user device 104 running an application with a number of functional modules, illustrated in the central box. The architecture 100 also illustrates how the application run by the user device 104 can interact with other service providers to enhance the information which can be provided to the user through the application. For instance, by communicating with insurance / benefit provider systems and pharmacies.

[0134] One of these functional modules is a journal module 102. The journal module 102 is configured to allow a user to maintain a journal relating to one or more medical conditions of the user. The journal may comprise a plurality of journal entries that detail episodes of the one or more medical conditions, such as symptoms, user specific health data, contextual information or the like. The journal may be used to monitor the one or more medical conditions for patterns, and to identify potential triggers for episodes of the one or more medical conditions. The journal module 102 may communicate with an external service, Adversed Events called. The journal module may transmit patient information associated with episodes of the one or more medical conditions to the adverse events service.

[0135] The journal may further maintain a record of the adherence of the user to a treatment regimen, such a medicament regimen. For instance, the journal entry can include a record logging a dose of medicament (e.g. a scheduled dose) that has been taken by the user, such as an injection log. The record can form a dose record including a variety of information associated with the dose administered by the user. The record can be stored as part of the journal entry or independently from the journal entry.

[0136] The functional module may further comprise a memory module, or database 106. The memory module 106 is configured to store journal entries made by the user via the journal module 102 for later retrieval and / or analysis. The memory module 106 may, in some embodiments, be linked to the cloud, and store journal entries remotely.

[0137] In some embodiments, the functional modules may further comprise a weather module 108. The weather module 108 is configured to determine and / or record weather conditions at the location of the user. The user location can be determined, for example, by a GPS capability of the user device. The weather module 108 may, for example, access an online weather forecasting system to obtain current weather conditions, previous weather conditions and / or predicted future weather conditions. The weather module 108 may provide weather conditions to the journal module 102 for inclusion in journal entries. As well as weather conditions such as general weather condition, temperature, humidity, air pressure and UV index, the weather module may additionally obtain air quality information such as pollen count, pollution index, NO2count and / or an air quality index.

[0138] Another of the functional modules is a user management module 110. The user management module 110 is responsible for obtaining user preferences and for generating notifications for output on the user device 104. Necessary data for the notification scheme may be stored on the memory module 106. The user management module 110 may also update the information held in the memory module 106 as the application is used.

[0139] The user management module 110 may define and help implement a notification scheme which determines when a notification should be generated and how it should be output on the user device 104. The notification scheme may have three main notification types; (i) a silent notification; (ii) a batched summary notification; and (iii) a push notification. In some embodiments, the silent notification may be pushed into the application silently and viewable only within the application. The user may be presented with the silent notification within the application, for example on an application home screen. In some embodiments, the silent notifications are surfaced to the user when certain requirements are met and do not require any action on user’s part. The batched summary notification may relate to several different reminders and other notifications. The user can interact with the batched summary notification to expand and show the individual notifications. The batch summary notification may indicate the number of notifications which are present for the user to review. The push notification may relate to a single notification and is pushed to the lock screen or home screen of the user device 104. In some embodiments, the push notifications are time-sensitive and actionable items that require the user’s immediate attention. They are reserved for actions related to the user’s treatment routine or as a follow up to actions that can impact the user’s access to the treatment / drug.

[0140] Notifications can escalate, i.e. move up the notification types, depending on the user’s action (or lack thereof). For example: a. When the user is 5 days away from their next medicament dose, their next dosing reminder will show up as a silent notification in the application, for example underneath the carousel on the App homepage. b. In the days leading up to the dosing, the application will push batch notifications to the user to either review instructional videos, book a call with a nurse, or review the instructions for self-administration. c. On the day of the dosing and an hour prior to the scheduled time, the application will push a notification to the user to take their dose. If the user’s medication is kept in the fridge, the notification will instruct the user to take their medicament out of the fridge. Interacting with this notification will trigger a warm-up timer, set to their medication dose.

[0141] Another of the functional modules is a Health / Assessment Module 112. The Health / Assessment Module 112 is responsible for onboarding the user and obtaining details regarding the user’s medical conditions and medicaments being used to treat these. The Health / Assessment Module 112 may also gather information about the user’s prescriptions and manage delivery of medicaments. Another of the functional modules is a Health Care Professional (HCP) Services Module. The HCP Services Module is responsible for facilitating contact with a nurse, doctor or other health care professional, including scheduling reminders relating to appointments and calls, prompting the user to create reports or otherwise prepare for an upcoming appointment or call, initiating voice or video calls, providing follow-up notifications after calls or appointments and initiating a journal entry after calls or appointments. The HCP Services Module interacts with an internetbased Patient Support program. Health care professionals may also have access to certain aspects and information held by the Patient Support program, in order to facilitate contact with the user and monitor the user’s treatment and / or disease progression.

[0142] Another of these functional modules is a Consent Module, which, in conjunction with other aspects of the system, is responsible for managing consents and permissions for accessing patient specific information, such as health related data for the user. The Memory Module 106 may be configured to store user ID and role information as well as consent templates for use by the Consent Module. The Memory Module 106 may also store consent and permission information input by the user via the consent Module, including any time limits set on the consents and permissions.

[0143] The Consent Module may communicate with an external service called Consent Management service. The consent and permission information generated by the Consent Module may be stored or copied to the Consent Management service. The Consent Management service may also be responsible for sending the patient specific information to third parties when the associated consents indicate that this is permitted.

[0144] Another of the functions modules is a Content Module. The content module is responsible for receiving and recording personalised content and / or preferences set by the user. The content module may communicate with an external service called Content Management 132. The content management service responsible for providing patient specific content or settings from an external user, such as a healthcare professional. The content module may interact with the memory module 106 to store the personalised content and / or settings.

[0145] Another of the functional modules is a Benefits Module, which, in conjunction with other aspects of the system, is responsible for managing patient access to health care. The Benefits Module may include a pharmacy integration service and / or a benefits integration service. The information generated by the benefits module may be responsible for sending patient specific information to third parties to indicate patient access to health care services. The benefits module may interact with external services, such as benefit provider systems and pharmacy services.

[0146] Another of the functional modules is an Analytics Module. The analytics module 126 is responsible for analysing, in conjunction with information received from the user management module 110 and journal module 102, the patient information associated with the status and / or treatment of the user’s medical conditions.

[0147] Another of the functional modules is a Messaging System. The Messaging System may communicate with the analytics module. For instance, if the analytics module identifies an episode or a trigger to an episode of the one or more medical conditioners of the user, the messaging system outputs a message communicating this result. The messaging system may communicate with an external service called an Information Hub. The information hub may store the data received from the messaging system. The information hub may also interact with other service providers to enhance the information which can be stored in respect of the user through the application. For instance, by communicating with the patient support program, insurance / benefit provider systems and pharmacies, adverse events services, and so on.

[0148] Referring now to Figure 2, a flowchart is shown illustrating steps performed by the application for monitoring a medicament dosing schedule and assisting the user with managing late doses. The application is executed by a computing device, such as a mobile phone, tablet computer, smartwatch or other wearable device. At step 200, the application monitors a current medicament dosing schedule set within the application. The medicament dosing schedule has a prescribed dosing frequency which is the primary metric being monitored.

[0149] At step 202, the application determines that a time period for taking a scheduled dose has been exceeded. The medicament dosing schedule may specify a day on which the user is to take their dose and the “time period” may be the entire 24-hour period of the specified day. A specific time within the day may not be required, and so long as the user takes the prescribed dose before midnight on the specified day, it is considered as being taken on time. The application may therefore determine that the time period for taking the scheduled dose has been exceeded if, by midnight on the specified day, it has not received a user input indicating that the user has taken the prescribed dose. In some other embodiments, a particular time on the specified day may be set as the end of the time period.

[0150] At step 204, the application determines if the time period for taking the scheduled dose has been exceeded by more than a lower threshold time. The lower threshold time is set within the application and may define the minimum time after which certain missed dose actions should be recommended to the user. The lower threshold time may be dependent on the particular medicament being monitored, the dosage of that medicament, the particular disease or diseases for which the medicament has been prescribed and the dosing frequency prescribed to the user. Examples of different dosing frequencies and lower threshold times are discussed below in relation to Figures 3a to 9.

[0151] If at step 204, it is determined that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, then the application continues to step 206, in which the application displays a late dose notification alerting the user to a missed dose. The late dose notification may be displayed as a push notification on the lock screen or home screen of the computing device as shown in Figures 3a and 4a. The late dose notification may alternatively or additionally appear as a notification within the application GUI. Any additional content of the late dose notification may depend on the particular medicament being monitored, the dosage of that medicament, the particular disease or diseases for which the medicament has been prescribed and the dosing frequency prescribed to the user. The late dose notification may advise the user not to take the missed dose now, but instead to wait until their next scheduled dose (as shown in Figure 3a). Alternatively, the late dose notification may advise the user to take the missed dose now, or as soon as possible.

[0152] The late dose notification can be selected or otherwise interacted with by the user. In step 208, in response to detecting a user interaction with the late dose notification, the application provides options for the user to either indicate that they have taken the scheduled dose or that they have not taken the scheduled dose. More than one form of each option may be presented. For example, options to indicate that the user took the scheduled dose that day or on the previous day may both be presented. Options for the user to indicate that they have not taken the scheduled dose may include an option to be reminded at a later time to take the scheduled dose and an option to begin a guided dosing process. If the user indicates that they wish to begin a guided dosing process, the application may then begin display of a step-by-step self dosing guide. The options may be presented on a display of the user device as selectable user interface icons. For example, the icons may be selectable soft buttons with suitable wording thereon. In some other embodiments the options could be presented aurally, either in addition to a visual presentation or as an alternative. The aural options may ask the user to specify with an aural reply whether they have taken the scheduled dose or not.

[0153] After receiving a user input selecting an option to indicate that they have taken the dose, the application may display a further screen asking the user to specify when they took the dose (as shown in Figure 3c). From the answer to this, the application can determine whether the dose was taken after the lower threshold time or not. At step 210, the application receives a user input indicating that the user has taken the scheduled dose after the lower threshold time. In response to this, at step 212, the application provides options for the user to either reset the current medicament dosing schedule or to maintain the current medicament dosing schedule. The options may be presented on a display of the user device as selectable user interface icons. For example, the icons may be selectable soft buttons with suitable wording thereon (as shown in Figures 3f and 5a). In some other embodiments the options could be presented aurally, either in addition to a visual presentation or as an alternative. The aural options may ask the user to specify with an aural reply whether they wish to reset or maintain the current medicament dosing schedule.

[0154] The process may end after the user makes a selection of one of the options presented in step 212. If the user chooses to maintain the current schedule, a suitable information screen may be shown. If the user chooses to reset the current schedule, a screen giving information about the new schedule may be shown. This screen may also allow the user to specify a time at which they wish to be reminded to take the next scheduled dose on the day it is due.

[0155] As discussed above, the application may be programmed to behave differently in relation to missed dose notifications and actions, depending on the particular medicament being monitored, the dosage of that medicament, the particular disease or diseases for which the medicament has been prescribed and the dosing frequency prescribed to the user. The flowcharts in Figures 7-9 detail three different exemplary ways in which the application may function.

[0156] Figure 7 shows a flow chart illustrating steps performed by the application for monitoring a medicament dosing schedule in a first exemplary mode. At step 700, the application is monitoring a current medicament dosing schedule set within the application and determines that a time period for taking a scheduled dose has been exceeded. This may also be termed a “late dose”. The medicament dosing schedule specifies a day on which the user is to take their dose and the “time period” is the entire 24-hour period of the specified day. Step 700 involves the application determining that the user has not made an input indicating that the scheduled dose was taken on the scheduled day. Step 700 may be substantially similar to a combination of steps 200, 202 and 204 described with reference to Figure 2.

[0157] In response to determining that a time period for taking a scheduled dose has been exceeded, at step 702 the application displays a notification to take the scheduled dose. This notification may also be termed a “late dose notification”. Its primary purpose is to alert the user to the fact that they appear to be late taking their scheduled dose, but it may additionally provide guidance as to the recommended next steps, which in this case is to take the scheduled dose as soon as possible. Step 702 may be substantially similar to step 206 described with reference to Figure 2.

[0158] In step 704, the application determines whether the user has taken the scheduled dose or not. The late dose notification can be selected or otherwise interacted with by the user. In response to detecting a user interaction with the late dose notification, the application provides options for the user to either indicate that they have taken the schedule dose or that they have not taken the schedule dose. The display of these options may correspond to step 208 described with reference to Figure 2. The user may indicate that they have taken the scheduled dose (YES in step 704) by selecting a first GUI icon with wording to that effect (see element 340 of Figure 4b). This may correspond to step 210 described with reference to Figure 2.

[0159] The user may indicate at step 706 that they have not taken the dose (NO in step 704) by selecting a second GUI icon with wording indicating that the user is ready to begin the dosing process now (see element 342 of Figure 4b). The user may alternatively indicate at step 706 that they have not taken the dose (alternative NO in step 704) by selecting a third GUI icon with wording indicating that the user wishes to be reminded to take the dose at a later time (see element 344 of Figure 4b).

[0160] When the application receives a user input indicating that the user has taken the scheduled dose late, at step 710 the application determines whether the dose was taken more than x days late or not, where x is a variable integer number of days. If the dose was taken more than x days late (YES at step 710), at step 712 the application automatically resets the dosing schedule. A suitable screen may be displayed informing the user that their dosing schedule will be reset (e.g., as shown in Figure 5b). If the dose was not taken more than x days late (NO at step 710), at step 714 the application provides a first option to reset the dosing schedule and at step 716 provides a second option to maintain the current dosing schedule. These options are provided simultaneously (e.g. as shown in Figure 5a). Steps 714 and 716 together may correspond to step 212 described with reference to Figure 2.

[0161] The process described in the flowchart of Figure 7 may be used for a dosing schedule having any dosing frequency (time between scheduled doses), and with any value of x. In one embodiment, the process in the flowchart of Figure 7 is used for a weekly schedule (a dosing frequency of 7 days) and the value of x is 6 days. In this embodiment, the application will display the options to reset or maintain the dosing schedule if the dose was taken 6 or fewer days after the scheduled day. If the dose was taken 7 or more days after the scheduled day, then the dosing schedule is automatically reset and the user is informed accordingly.

[0162] Figure 8 shows a flow chart illustrating steps performed by the application for monitoring a medicament dosing schedule in a second exemplary mode. At step 800, the application is monitoring a current medicament dosing schedule set within the application and determines that a time period for taking a scheduled dose has been exceeded. This may also be termed a “late dose”. The medicament dosing schedule specifies a day on which the user is to take their dose and the “time period” is the entire 24-hour period of the specified day. Step 800 involves the application determining that the user has not made an input indicating that the scheduled dose was taken on the scheduled day. Step 800 may be substantially similar to a combination of step 200 and 202 described with reference to Figure 2.

[0163] At step 802, the application determines whether the time period for taking a scheduled dose has been exceeded by more than x’ days or not. This step may be substantially similar to step 204 of Figure, where x’ is equivalent to the lower threshold time. If the time period for taking the scheduled dose has not been exceeded by more than x’ days (NO in step 802), at step 804 the application displays a late dose notification alerting the user to a potential late dose (e.g., Figure 4a) and optionally advising them to take the scheduled dose.

[0164] In step 808, the application determines whether the user has taken the scheduled dose or not. The late dose notification from step 804 can be selected or otherwise interacted with by the user. In response to detecting a user interaction with the late dose notification, the application provides options for the user to either indicate that they have taken the schedule dose or that they have not taken the schedule dose.

[0165] The user may indicate at step 810 that they have not taken the dose (NO in step 808) by selecting a second GUI icon with wording indicating that the user is ready to begin the dosing process now (see element 342 of Figure 4b). The user may alternatively indicate at step 812 that they have not taken the dose (alternative NO in step 808) by selecting a third GUI icon with wording indicating that the user wishes to be reminded to take the dose at a later time (see element 344 of Figure 4b).

[0166] The user may indicate that they have taken the scheduled dose (YES in step 808) by selecting a first GUI icon with wording to that effect (see element 340 of Figure 4b). In response, at step 814, the application maintains the current dosing schedule. The application may display a suitable screen informing the user that their dosing schedule will be maintained (e.g., as shown in Figure 4c).

[0167] Returning to step 802, if the time period for taking the scheduled dose has been exceeded by more than x’ days (YES in step 802), at step 806 the application displays a late dose notification alerting the user to a potential late dose and advising them to wait until their next scheduled dose, i.e., not to take the missed dose (e.g., Figure 3a). Answering YES in step 802 may be equivalent to answering YES in step 204 of Figure 2, while step 806 may be substantially similar to step 206 described with reference to Figure 2.

[0168] In step 816, the application determines whether the user has taken the scheduled dose or not. The late dose notification from step 806 can be selected or otherwise interacted with by the user. In response to detecting a user interaction with the late dose notification, the application provides options for the user to either indicate that they have taken the schedule dose or that they have not taken the schedule dose, e.g., as shown in Figure 3b. The display of these options may correspond to step 208 described with reference to Figure 2. The user may indicate that they have not taken the dose (NO in step 816) by selecting a GUI icon with wording to that effect or more general negative wording (see element 306 of Figure 3b). In response, the application proceeds to step 814 in which the application maintains the current dosing schedule. The application may display a suitable screen informing the user that their dosing schedule will be maintained (e.g., as shown in Figure 4c).

[0169] The user may indicate that they have taken the scheduled dose (YES in step 816) by selecting a GUI icon with wording to that effect (see element 308 of Figure 3b). This may correspond to step 210 described with reference to Figure 2. In response, the application determines in step 818 whether the dose was taken more than y’ days late or not, where y’ is a variable integer number of days. If the dose was taken more than y’ days late (YES at step 818), at step 820 the application automatically resets the dosing schedule. A suitable screen may be displayed informing the user that their dosing schedule will be reset (e.g., as shown in Figure 5b). If the dose was not taken more than y’ days late (NO at step 818), at step 822 the application provides a first option to reset the dosing schedule and at step 824 provides a second option to maintain the current dosing schedule. These options are provided simultaneously (e.g., as shown in Figure 5a). Steps 822 and 824 together may correspond to step 212 described with reference to Figure 2.

[0170] The process described in the flowchart of Figure 8 may be used for a dosing schedule having any dosing frequency (time between scheduled doses), and with any value of x’ and any value of y’ greater than x’. In one embodiment, the process in the flowchart of Figure 8 is used for a two-weekly schedule (a dosing frequency of 14 days), the value of x’ is 7 days and the value of y’ is 13 days. In this embodiment, the application will provide the notification to take the scheduled dose if it is 7 or fewer days after the scheduled day. The application will provide the notification to wait for the next scheduled dose if it is 8 or more days after the scheduled day. In this embodiment, the application will also display the options to reset or maintain the dosing schedule if the dose was taken 13 or fewer days after the scheduled day. If the dose was taken 14 or more days after the scheduled day, then the dosing schedule is automatically reset and the user informed accordingly.

[0171] Figure 9 shows a flow chart illustrating steps performed by the application for monitoring a medicament dosing schedule in a third exemplary mode. At step 900, the application is monitoring a current medicament dosing schedule set within the application and determines that a time period for taking a scheduled dose has been exceeded. This may also be termed a “late dose”. The medicament dosing schedule specifies a day on which the user is to take their dose and the “time period” is the entire 24-hour period of the specified day. Step 900 involves the application determining that the user has not made an input indicating that the scheduled dose was taken on the scheduled day.

[0172] At step 902, the application determines whether the time period for taking a scheduled dose has been exceeded by more than x” days or not. In this exemplary mode, x” is the only threshold value used. If the time period for taking the scheduled dose has not been exceeded by more than x” days (NO in step 902), at step 904 the application maintains the current dosing schedule. The application may display a suitable screen informing the user that their dosing schedule will be maintained (e.g., as shown in Figure 4c).

[0173] At step 906, the application determines whether the user has taken the scheduled dose or not. While the scheduled dose is x” or fewer days late, the application does not display any late dose notification. If the application does not receive user input indicating that the does has been taken (NO in step 906), the application continues to monitor the potentially late dose in step 902 If the application does receive user input indicating that the does has been taken fewer than x” days late (YES in step 906), at step 908 the application maintains the current dosing schedule. The application may display a suitable screen informing the user that their dosing schedule will be maintained (e.g., as shown in Figure 4c).

[0174] Returning to step 902, if the time period for taking the scheduled dose has been exceeded by more than x” days (YES in step 902), at step 910 the application displays a late dose notification alerting the user to a potential late dose (see Figure 6) and optionally advising them to take the scheduled dose.

[0175] In step 912, the application again determines whether the user has taken the scheduled dose or not. The late dose notification from step 910 can be selected or otherwise interacted with by the user. In response to detecting a user interaction with the late dose notification, the application provides options for the user to either indicate that they have taken the schedule dose or that they have not taken the schedule dose, e.g., as shown in Figure 4b. The user may indicate that they have taken the scheduled dose (YES in step 912) by selecting a first GUI icon with wording to that effect (see element 340 of Figure 4b). In response, at step 918 the application automatically resets the dosing schedule. A suitable screen may be displayed informing the user that their dosing schedule will be reset (e.g., as shown in Figure 4d or Figure 5b).

[0176] The user may indicate at step 914 that they have not taken the dose (NO in step 912) by selecting a second GUI icon with wording indicating that the user is ready to begin the dosing process now (see element 342 of Figure 4b). The user may alternatively indicate at step 916 that they have not taken the dose (alternative NO in step 912) by selecting a third GUI icon with wording indicating that the user wishes to be reminded to take the dose at a later time (see element 344 of Figure 4b).

[0177] The process described in the flowchart of Figure 9 may be used for a dosing schedule having any dosing frequency (time between scheduled doses), and with any value of x”. In one embodiment, the process in the flowchart of Figure 9 is used for a four-weekly schedule (a dosing frequency of 28 days) and the value of x” is 7 days. In this embodiment, the application will not adjust the dosing schedule if the user takes a dose 7 or fewer days after the scheduled day. The application will provide the notification to take the scheduled dose if it is 8 or more days after the scheduled day. If the dose was taken 8 or more days after the scheduled day, then the dosing schedule is automatically reset and the user is informed accordingly.

[0178] Referring now to Figures 3a to 3g, screenshots displayed by the application when monitoring the current medicament dosing schedule, and providing guidance and follow up options to the user, are shown according to some embodiments. In the first screen 300 shown in Figure 3a, the application causes a notification 302 to be displayed on the display of the user device 104. The notification 302 may be a push message displayed on the lock screen or home screen of the user device 104. The notification 302 may be displayed in response to the application determining that a time period for taking a scheduled dose has been exceeded by more than a lower threshold time. For example, if the time period for taking a scheduled dose has been exceeded by more than a lower threshold time and the application has not received input from the user confirming that the scheduled dose was taken, then the notification 302 is displayed. The notification 302 may be termed a “late dose notification”. The notification 302 may alert the user to the fact that they appear to be late taking a scheduled dose. Notification 302 states “Looks like you’re more than 7 days late with your last dose”, where in this instance 7 days is the lower threshold time. However, any suitable wording alerting the user may be used. The notification 302 also provides some guidance to the user, in this case by stating “We recommend that you wait until your next scheduled dose on June 15”. The date and wording given are merely examples. In this manner, the application may implement guidelines for missed doses for the particular medicament / disease combination being treated and proactively provides this guidance to the user at the most effective time.

[0179] When the user interacts with the notification 302, the application may run and show the second screen 304 of Figure 3b. This second screen 304 repeats the information that the user is more than 7 days late with their dose and that the recommendation is to wait until their next scheduled dose. The second screen 304 may also explicitly state that this recommendation is based on the guidance for missed doses and / or provide a link to view this guidance in full. The second screen 304 also communicates that if the user has already taken the dose, then they can log it in the application so as to keep an accurate record.

[0180] The second screen 304 also displays two options for the user to indicate that they have taken the scheduled dose or to indicate that they have not taken the scheduled dose. A first user selectable option 306 may be a negative option and may have suitable wording such as “Close” or “I have not taken my last scheduled dose” or similar. A second user selectable option 308 may be a positive option and may have suitable wording such as “I took my last scheduled dose” or similar. If the user selects the first user selectable option 306 the application may close. Alternatively, the application may first display a confirmation screen (not shown) in which it is communicated that the user’s current dosing schedule will be maintained and reminding them of the date of their next scheduled dose.

[0181] If the user selects the second user selectable option 308, the application begins a dose recording process by displaying a third screen 310 as shown in Figure 3c. The third screen has suitable wording asking the user to input when they took their last dose and one or more input boxes 312 for specifying the day and optionally time at which the last dose was taken. The input boxes 312 may be implemented as drop down menus, scrollable or slidable icons, selection wheels, free text entry boxes or any other suitable data entry means. After confirming the day and optionally time at which the last dose was taken, the application may display a fourth screen 316 as shown in Figure 3d, in which a model of the human body (e.g., a mannequin) is shown, with a number of different body regions identified. The body regions relate to common and pre-defined injection areas. This allows both the user and the healthcare professional to track the location of injections over time and ensure that the same region is not overused for injections. If the dose of medicament is not given by injection or infusion, then the fourth screen 316 is not shown.

[0182] As used herein, the term injection or self-injection is intended to encompass intra-venous injection, intra-muscular injection, infusion, or any needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0183] When the user selects to continue from the fourth screen 316, the application displays a fifth screen 318, as shown in Figure 3e. The fifth screen 318 asks the user to indicate how easy or difficult they found administering their dose using a number scale. Any other suitable indication method may be used, such as qualitative description (“hard”, “OK”, “easy” etc.) or pictorial indications, such as emojis. While the application may also provide a full journal function allowing the user to keep track of their treatment and disease progression in detail, the late dose journal entry may be brief, in order to encourage users to complete the journal entry for the late dose, so that the dosing record can be kept up to date.

[0184] After completing the short journal entry shown in Figures 3c to 3e, the application confirms via the information entered in the third screen 310 that the user took their scheduled dose late by more than the lower threshold time, which in this embodiment is 7 days. In response, the application displays a sixth screen 320 as shown in Figure 3f, informing that user that they took their scheduled dose more than 7 days late and recommending that they contact their Healthcare Professional to obtain guidance on their dosing schedule. The sixth screen 320 also provides options for the user to reset the current medicament dosing schedule or to maintain the current medicament dosing schedule. A selectable reset button 322 is provided with suitable wording such as “Reset my injection reminders”. A selectable maintain button 324 is also provided with suitable wording such as “Maintain my current routine”.

[0185] When the user selects the reset button 322, the application displays a seventh screen 326 displaying dosing routine details, as shown in Figure 3g. The seventh screen 326 contains one or more information boxes 328 detailing the day of the next scheduled dose and optionally also the dosing frequency, which in this instance is 2 weeks. The information boxes 328 may not be editable by the user and may have a different appearance (such as being greyed out) in order to indicate this. The seventh screen 326 also displays a reminder entry box 330. The user may interact with the reminder entry box 330 to set a time at which they wish to be reminded about their next scheduled injection, on the day it is due. The reminder entry box 330 may be implemented as a drop-down menu, scrollable or slidable icon, selection wheel, free text entry box or any other suitable data entry means. Lastly, the seventh screen 326 may display a Step- by-step guide toggle 332, which allows the user to select whether or not they wish to view the step-by-step dosing guide at the time of their next scheduled dose.

[0186] Figures 4a to 4f show exemplary screenshots displayed by the application relating to further notifications and options for subsequent actions.

[0187] In the eighth screen 334 shown in Figure 4a, the application causes a notification 336 to be displayed on the display of the user device 104. The notification 336 may be a push message displayed on the lock screen or home screen of the user device 104. The notification 336 may alert the user to the fact that they may be late taking a scheduled dose. Notification 336 states “Did you miss your last dose?” and / or “Looks like you missed you last dose scheduled on June 1”. However, any suitable wording alerting the user may be used. The notification 336 may also provide some guidance to the user, such as recommending that the user take their scheduled dose now or as soon as possible.

[0188] The notification 336 may be displayed in two different situations, depending on the dosing frequency and late dose guidelines for the specific medicament / disease combination being monitored. In a first situation, the notification 336 is displayed in response to the application determining that a time period for taking a scheduled dose has been exceeded by more than a lower threshold time. For example, if the time period for taking a scheduled dose has been exceeded by more than the lower threshold time and the application has not received input from the user confirming that the scheduled dose was taken, then the notification 336 is displayed. The notification 336 may therefore be a form of “late dose notification” which is displayed instead of notification 302 shown in Figure 3a. In some embodiments, the notification 336 is displayed when the dosing frequency is 7 days and the lower threshold time is 1 day, i.e., if the user is 1 or more days late with their dose, then the notification 336 is displayed (see also flowchart of Figure 7).

[0189] In a second situation, the notification 336 is displayed in response to the application determining that a time period for taking a scheduled dose has been exceeded by / ess than a lower threshold time. For example, if the time period for taking a scheduled dose has been exceeded by less than the lower threshold time and the application has not received input from the user confirming that the scheduled dose was taken, then the notification 336 is displayed. In this situation the notification 336 may be displayed in addition to the notification 302 of Figure 3a and may be termed a “missed dose notification” to distinguish it from the “late dose notification” discussed in relation to Figure 3a. As will be appreciated, in the second situation, if the user is late with their dose by more than the lower threshold time, then the first screen 300 of Figure 3a would be shown, while if they are late by less than the lower threshold time, then the eighth screen 334 of Figure 4a would be shown. Thus, the missed dose notification 336 may initially be shown for one or more days and if the user does not interact with the missed dose notification 336 before the lower threshold time is exceeded, then the late dose notification 302 is shown in place of the missed dose notification 336. In some embodiments, the notification 336 is displayed when the dosing frequency is 14 days and the lower threshold time is 7 days, i.e., if the user is 7 or fewer days late with their dose, then the notification 336 is displayed. If the user then becomes 8 or more days late with their dose, then the notification 302 is displayed (see also flowchart of Figure 8).

[0190] In this manner, the application may implement guidelines for missed doses for the particular medicament / disease combination being treated for multiple different dosing schedules and proactively provides this guidance to the user at the most effective time.

[0191] In either of the two situations described above, when the user interacts with the notification 336, the application may run and show the ninth screen 338 of Figure 4b. This ninth screen 338 displays an option for the user to indicate that they have taken the last scheduled dose and two options for indicating that they have not yet taken the last scheduled dose. A first selectable option 340 states that the user has taken the last scheduled dose and may comprise suitable wording such as “I’ve taken that dose and would like to record the details”. A second selectable option 342 states that the user has not taken the dose but will do so now and may comprise suitable wording such as “I’m ready to begin the process now”. A third selectable option 344 states that the user has not taken the dose and wishes to be reminded to do so later and may comprise suitable wording such as “Remind me later today”.

[0192] If the user selects the first selectable option 340, the application may display suitable journal entry screens, such as the third to fifth screens 310, 316, 318 as shown in Figures 3c to 3e. If the user selects the second selectable option 342, the application may display an upcoming injection screen, such as the thirteenth screen 354 shown in Figure 4f. The thirteenth screen 354 may display dosing preparation information confirming the date of the next dose and optionally the time at which the user has asked to be reminded to take this dose, as well as the dosing method and dosage. The user can review this information and select a continue button. The application may then display a step-by-step dosing guide. Where the dose is an injection, the preparation information may also include a reminder to take medicament out of a refrigerator a predetermined time before performing the injection. The application may also provide a countdown timer to assist the user with monitoring this warm-up period. If the user selects the third selectable option 344, the application may display a suitable reminder generation screen. The reminder may be limited to being later on the same day (or within the same 24-hour period).

[0193] Figures 4c and 4d show examples of final screens which may be displayed in different situations, depending on the dosing frequency and late dose guidelines for the specific medicament / disease combination being monitored. Figure 4c shows a tenth screen 346 which is shown when the user has taken their dose 7 or fewer days late while on a dosing frequency of 14 days. In this situation, the tenth screen 346 communicates that no change will be made to the user’s dosing schedule and informs them of the date of their next scheduled dose according to the current schedule, i.e., the user does not have an option to change their dosing schedule in this situation.

[0194] In some situations, an upper threshold time is defined above which the user’s dosing schedule is automatically reset by the application. Figure 4d shows an eleventh screen 348 which is shown when the user has taken their dose later than the upper threshold time. The upper threshold time may be equal to the dosing frequency. For example, the eleventh screen 348 may be shown when the user has taken their dose 14 or more days late while on a dosing frequency of 14 days. The eleventh screen 348 communicates that the user is late (in this example they are more than 14 days late while on a dosing frequency of 14 days), although it may not explicitly state that they have exceeded an upper threshold. The eleventh screen 348 informs the user that their dosing schedule will be reset and provides a selectable button 350 for the user to confirm their understanding of this and cause the schedule to be reset. Resetting the dosing schedule generally means that the dosing frequency is reset from the current day.

[0195] Figure 4e shows a twelfth screen 352 which may be shown whenever the dosing schedule is reset. The twelfth screen 352 shows the main GUI of the application. An additional prominent notification is shown in the GUI communicating that the dosing schedule has been reset.

[0196] Figures 5a and 5b show two further examples of final screens which may be displayed in different situations, depending on the dosing frequency and late dose guidelines for the specific medicament / disease combination being monitored. Figure 5a shows a fourteenth screen 500 which is shown when the user has taken their dose more than 1 day late while on a dosing frequency of 7 days. In this situation, the fourteenth screen 500 informs the user that they took their scheduled dose outside of their treatment cycle and recommends that they contact their Healthcare Professional to obtain guidance on their dosing schedule. The fourteenth screen 500 also provides options for the user to reset the current medicament dosing schedule or to maintain the current medicament dosing schedule. A selectable reset button 502 is provided with suitable wording such as “Reset my injection reminders”. A selectable maintain button 504 is also provided with suitable wording such as “Maintain my current routine”. When the user selects the reset button 502, the application displays the seventh screen 326 displaying dosing routine details, as shown in and described above with reference to Figure 3g.

[0197] Figure 5b shows a fifteenth screen 506 which is shown when the user has taken their dose 7 or more days late while on a dosing frequency of 7 days. In this situation, the fifteenth screen 506 informs the user that they took their scheduled dose outside of their treatment cycle and recommends that they contact their Healthcare Professional to obtain guidance on their dosing schedule. The fifteenth screen 506 informs the user that their dosing schedule will be reset and provides a selectable button 508 for the user to confirm their understanding of this and cause the schedule to be reset, i.e., the user does not have an option to maintain their dosing schedule in this situation.

[0198] Figure 6 shows another example of a screen 600 containing a late dose notification 602 which the application causes to be displayed on the display of the user device 104. The notification 602 may be a push message displayed on the lock screen or home screen of the user device 104. The notification 602 is displayed in response to the application determining that a time period for taking a scheduled dose has been exceeded by more than a lower threshold time. For example, if the time period for taking a scheduled dose has been exceeded by more than a lower threshold time and the application has not received input from the user confirming that the scheduled dose was taken, then the notification 602 is displayed. The notification 602 may be termed a “late dose notification”. The notification 602 may alert the user to the fact that they appear to be late taking a scheduled dose. Notification 602 states “Looks like you’re more than 7 days late with your last dose”, where in this instance 7 days is the lower threshold time. However, any suitable wording alerting the user may be used.

[0199] The notification 602 also provides some guidance to the user, in this case by stating “When you take your next dose, we’ll readjust your treatment routine”. In this manner, the application may implement guidelines for missed doses for the particular medicament / disease combination being treated and proactively provides this guidance to the user at the most effective time.

[0200] When the user interacts with the notification 602, the application may run and show the ninth screen 338 of Figure 4b, from which the user can input whether they have taken the dose or not. Once the user indicates that they have taken the dose, the application either displays a screen similar to the tenth screen 346 of Figure 4c, in which the user’s dosing schedule is maintained, i.e. they have no option to reset the dosing schedule, or the application displays a screen similar to the eleventh screen 348 of Figure 4d in which the user’s dosing schedule is reset, i.e. they have no option to maintain the dosing schedule. The example of Figure 6 may apply to a dosing frequency of 28 days with a lower threshold time of 7 days (see also flowchart of Figure 9).

[0201] Figure 10 illustrates schematically a user device 400 according to some embodiments. The user device 400 may be a mobile phone or tablet computer. The user device 400 is an example of a wireless communication device. The user device may alternatively be referred to as a communication device, computer, computing device or mobile device and is not necessarily associated with a single user. The user device 400 is configured to communicate wirelessly with a communications network using a wireless communication protocol, for example but not exclusively 3GPP LTE and / or New Radio (NR) or WiFi (IEEE 802.11). The user device 400 may also be configured to communicate using Bluetooth, NFC, Zigbee, Ultra Wideband, IrDa or similar. The communications network may comprise one or more network nodes. The communications network may further be connected via a core network and / or an intermediate network to a host computer (not shown) which may be embodied in the hardware and / or software of a standalone server, a cloud-implemented server or a distributed server. The user device 400 and the host computer may be configured to communicate data.

[0202] The user device 400 may comprise hardware that includes processing circuitry 401 . The processing circuitry 401 may comprise a processor 402 and a memory 404. The user device 400 may also comprise a wireless transceiver 406, user inputs 408, a display 412, a camera 410, a microphone 416, and RFID reader 418 and a speaker 414. The wireless transceiver 406 may be configured to set up and maintain a wireless connection to a network node. The wireless transceiver 406 may comprise one or more radio transmitters and one or more radio receivers. The display may be a touch sensitive display and may be based on capacitive or resistive sensing technology. The processing circuitry 401 may for instance include a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. The processor 402 may be configured to read and / or write from the memory 404. The memory 404 may comprise a volatile and / or nonvolatile memory, for example a cache, RAM (Random Access Memory) and / or ROM (Read- Only Memory) etc.

[0203] The user device 400 may comprise software which is stored, for example, in memory 404. The software may be executable by the processing circuitry 401 . The software may include an application, for example the application described above. In some embodiments the host computer may communicate with the application. The application may request data from the host computer and / or provide user data to the host computer.

[0204] The processing circuitry 401 may be configured to perform or cause to be performed any of the methods described herein. In some embodiments, the software / program may include instructions that, when executed by the processing circuitry 401 cause the processing circuitry 401 to perform the methods described herein.

[0205] The memory 404 may comprise both a program memory storing program code (e.g. software or firmware) and main memory storing data. The processing circuitry 401 may be configured to execute the program code stored in the program memory and to read, write and delete data from the main memory. In some embodiments, the program code may be an application which can be downloaded and installed on the user device 400. The application may be a disease and treatment management and tracking tool for use by patients. The program memory may for instance be a Read-Only Memory (ROM), and the main memory may for instance be a Random Access Memory (RAM).

[0206] The user device 400 comprises one or more user inputs 408, for example a touchscreen, keypad or keyboard, accelerometer or gyroscope, mouse or microphone 416 for receiving voice commands. User device 400 may also comprise a camera 410 configured to capture images of a user and images of labels, codes and the like visible on the medicament administration devices, packaging or storage solutions. The user device 400 may be configured to scan medicament administration devices (such as an injection device or inhaler) using a scanning device. The scanning device may refer to either the camera 410 or RFID reader 418. The term “scanning” as used in relation to the user device 400 may refer to use of either of these components to read information provided externally or internally on medicament administration devices.

[0207] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0208] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0209] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body. The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, in which one or more organic substituent (e.g., a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0210] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0211] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0212] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0213] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6R mAb (e.g., Sarilumab), and anti IL-4R mAb (e.g., Dupilumab).

[0214] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0215] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0216] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0217] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

Claims

Claims1 . A non-transitory computer readable storage medium comprising instructions that, when executed by a computing device, cause the computing device to: execute a program for managing a user’s medical condition or treatment; monitor a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determine that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, provide options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program.

2. The non-transitory computer readable storage medium of claim 1 , wherein determining that a time period for taking a scheduled dose has been exceeded comprises determining that the program has not received a user input indicating that a dose has been taken when the time period ends.

3. The non-transitory computer readable storage medium of claim 1 or claim 2, wherein the late dose notification is displayed as a push notification on the lock screen or home screen of the computing device.

4. The non-transitory computer readable storage medium of any preceding claim, wherein providing options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose comprises displaying a first selectable user interface icon and a second selectable user interface icon.

5. The non-transitory computer readable storage medium of any preceding claim, wherein the options for the user to indicate that they have not taken the scheduled dose comprise anoption to begin a guided dosing process and an option to set a reminder to perform the dosing process at a later time.

6. The non-transitory computer readable storage medium of claim 5, wherein the instructions are further configured, when executed by the computing device, to cause the computing device to: in response to receiving a user selection of the option to begin the guided dosing process, begin display of a step-by-step self-dosing guide.

7. The non-transitory computer readable storage medium of any preceding claim, wherein the instructions are further configured, when executed by the computing device, to cause the computing device to, when it is detected that the user indicates that they have taken the scheduled dose: provide a user interface for specifying the date and time that the dose was taken; and provide a user interface for specifying a body location into which the dose was injected or infused.

8. The non-transitory computer readable storage medium of any preceding claim, wherein when it is detected that the user selects the option to re-set the medicament dosing schedule, the instructions are further configured, when executed by the computing device, to cause the computing device to provide a schedule re-set screen informing the user of the day of the next scheduled dose, the schedule re-set screen configured to allow the user to set a time to be reminded on the day of the next scheduled dose.

9. The non-transitory computer readable storage medium of claim 8, wherein the schedule re-set screen is further configured to allow the user to specify whether they want to review a step-by-step dosing guide at the time of the next scheduled dose.

10. The non-transitory computer readable storage medium of any preceding claim, wherein the instructions are further configured, when executed by the computing device, to cause the computing device to: in response to determining that the time period for taking the scheduled dose has been exceeded by more than an upper threshold time, display the late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; andwhen it is detected that the user indicates that they have taken the scheduled dose after the upper threshold time, displaying a dosing re-set information screen informing the user that the medicament dosing schedule will be re-set.11 . The non-transitory computer readable storage medium of claim 10, wherein the upper threshold time is equal to the dosing frequency.

12. The non-transitory computer readable storage medium of any preceding claim, wherein the dosing frequency is one of 7 days, 14 days or 28 days.

13. The non-transitory computer readable storage medium of any of claims 1 to 11 , wherein the late dose notification recommends that the user waits until their next scheduled dose.

14. The non-transitory computer readable storage medium of claim 13, wherein the dosing frequency is 14 days and the lower threshold time is 7 days.

15. The non-transitory computer readable storage medium of any of claims 1 to 11 , wherein the late dose notification recommends that the user takes their next scheduled dose.

16. The non-transitory computer readable storage medium of claim 15, wherein the dosing frequency is 7 days and lower threshold time is 1 day.

17. The non-transitory computer readable storage medium of any of claims 1 to 11 , wherein the instructions are further configured, when executed by the computing device, to cause the computing device to: in response to determining that the time period for taking the scheduled dose has been exceeded by less than the lower threshold amount, display a missed dose notification alerting the user to a missed dose; in response to detecting user interaction with the missed dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose before the lower threshold time, maintain the current medicament dosing schedule.

18. A user device comprising processing circuitry configured to: execute a program for managing a user’s medical condition or treatment;monitor a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determine that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, provide options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program.

19. A computer implemented method, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determining that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, displaying a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, providing options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, providing options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program.

20. A non-transitory computer readable storage medium comprising instructions that, when executed by a computing device, cause the computing device to: execute a program for managing a user’s medical condition or treatment; monitor a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determine that a time period for taking a scheduled dose has been exceeded;in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, displaying a dosing re-set information screen informing the user that the medicament dosing schedule will be re-set.21 . The non-transitory computer readable storage medium of claim 20, wherein the late dose notification recommends that the user takes their next scheduled dose.

22. The non-transitory computer readable storage medium of claim 21 , wherein the dosing frequency is 28 days and lower threshold time is 7 days.

23. The non-transitory computer readable storage medium of claim 9, wherein the user further self-administers the next scheduled dose.

24. A computer implemented method of treating a subject with an anti-interleukin-4 receptor alpha (anti-IL-4Ra) antibody, comprising providing guidance on administering a therapeutically effective amount of an anti-IL-4Ra antibody to a subject, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determining that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, displaying a late dose notification alerting the user to a missed dose; in response to detecting user interaction with the late dose notification, providing options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, providing options for the user to (i) reset the current medicament dosing schedule within the program or (ii) maintain the current medicament dosing schedule within the program, wherein the anti-IL-4Ra antibody comprises:a variable heavy chain CDR1 of SEQ ID NO:1 (GFTFRDYA); a variable heavy chain CDR2 of SEQ ID NO:2 (ISGSGGNT); a variable heavy chain CDR3 of SEQ ID NO:3 (AKDRLSITIRPRYYGLDV); a variable light chain CDR1 of SEQ ID NO:4 (QSLLYSIGYNY); a variable light chain CDR2 of SEQ ID NO:5 (LGS); and a variable light chain CDR3 of SEQ ID NO:6 (MQALQTPYT).

25. The computer implemented method of claim 24, wherein the dosing frequency is one of 7 days, 14 days or 28 days.

26. The computer implemented method of claim 24, wherein the late dose notification recommends that the user waits until their next scheduled dose.

27. The computer implemented method of claim 24, wherein the dosing frequency is 14 days and the lower threshold time is 7 days.

28. The computer implemented method of claim 24, wherein the late dose notification recommends that the user takes their next scheduled dose.

29. The computer implemented method of claim 24, wherein the dosing frequency is 7 days and lower threshold time is 1 day.

30. The method of claim 24, wherein the anti-IL-4Ra antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 13 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO:14.31 . A computer implemented method of treating a subject with an anti-interleukin-4 receptor alpha (anti-IL-4Ra) antibody, comprising providing guidance on administering a therapeutically effective amount of an anti-IL-4Ra antibody to a subject, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current medicament dosing schedule set within the program, the medicament dosing schedule having a dosing frequency; determining that a time period for taking a scheduled dose has been exceeded; in response to determining that the time period for taking the scheduled dose has been exceeded by more than a lower threshold time, display a late dose notification alerting the user to a missed dose;in response to detecting user interaction with the late dose notification, provide options for the user to (i) indicate that they have taken the scheduled dose or (ii) indicate that they have not taken the scheduled dose; and when it is detected that the user indicates that they have taken the scheduled dose after the lower threshold time, displaying a dosing re-set information screen informing the user that the medicament dosing schedule will be re-set, wherein the anti-IL-4Ra antibody comprises: a variable heavy chain CDR1 of SEQ ID NO:1 (GFTFRDYA); a variable heavy chain CDR2 of SEQ ID NO:2 (ISGSGGNT); a variable heavy chain CDR3 of SEQ ID NO:3 (AKDRLSITIRPRYYGLDV); a variable light chain CDR1 of SEQ ID NO:4 (QSLLYSIGYNY); a variable light chain CDR2 of SEQ ID NO:5 (LGS); and a variable light chain CDR3 of SEQ ID NO:6 (MQALQTPYT).

32. The computer implemented method of claim 31 , wherein the late dose notification recommends that the user takes their next scheduled dose.

33. The computer implemented method of claim 32, wherein the dosing frequency is 28 days and lower threshold time is 7 days.

34. The computer implemented method of claim 24 or 31 , wherein the administering is via a pre-filled syringe.

35. The computer implemented method of claim 24 or 31 , wherein the administering is via a pre-filled pen.

36. The computer implemented method of claim 24 or 31 , wherein the administering is via an autoinjector.

37. The computer implemented method of claim 24 or 31 , wherein the anti-IL-4Ra antibody is administered to the subject as an initial dose followed by one or more secondary doses.38 . The computer implemented method of claim 37, wherein the initial dose is about 600 mg and each secondary dose is about 300 mg.

39. The computer implemented method of claim 37, wherein the initial dose is about 400 mg and each secondary dose is about 200 mg.

40. The computer implemented method of claim 37, wherein each secondary dose is administered every 2 weeks.41 . The computer implemented method of claim 31 , wherein the anti-IL-4Ra antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 13 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO:14.

42. The computer implemented method of claim 24 or 31 , wherein, in response to the late dose notification, the user self-administers a therapeutically effective amount of an anti-IL-4Ra antibody.

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