SELECTED IMPORTANT SAFETY INFORMATION: You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi. CONTINUE READING BELOW

Get to know Jivi®

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    The main clinical study, and extension study of Jivi® were designed to reflect
    real-world treatment4,6

    Jivi dosing was tailored to patients' bleeding tendencies4

    Diagram of main clinical study and long-term extension study illustrating treatment frequency variations between high and low bleeding tendencies.

    IU, international units; kg, kilograms.
    *112 patients entered prophylactic treatment arms; an additional 20 patients entered a control arm of on-demand treatment. Two patients in the prophylactic arms left the study prematurely during the run-in period.1
    Defined as joint or muscle bleeds and no identified trauma.1,4
    112 patients entered prophylactic treatment arms; an additional 20 patients entered a control arm of on-demand treatment. Two patients in the prophylactic arms left the main study prematurely during the run-in period.1
    §121 of 134 patients included in the main PROTECT VIII trial continued in the extension study, receiving either on demand treatment (n=14) or prophylaxis (n=107).8
    Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate variable frequency group.8
    **As of January 2018 interim analysis.4,8

    Meet Evan, a Jivi patient who participated in the Jivi Protect VIII clinical trial.

    Effective bleed protection with Jivi® in the main clinical study1

    Table of ABR results from the main clinical study.

    88.2% reduction in ABR versus on-demand treatment1
    ABR, annualized bleed rate.
    *n=11; n=13 (twice weekly: low; high).1
    Patients with 0 or 1 spontaneous bleed (defined as a joint or muscle bleed and no identified trauma) during weeks 1-10 of the main study.1,4
    Patients with 2 or more spontaneous bleeds (defined as joint or muscle bleeds and no identified trauma) during weeks 1-10 of the main study.1,4
    §Nine of the 13 subjects in this group were on prior prophylaxis and observed to have a mean number of 17.4 bleeds in the 12 months prior to study entry.1
    n=43 (every 5 days).1

    ABRs assessed with Jivi® in the long-term extension study10

    Table of ABR results from the long-term extension study.

    *As of 1/31/2018 cut off.10
    Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate variable frequency group.6
    ABR, annualized bleed rate.

     

    Jivi provided effective treatment of bleeds1

    Graphic illustrating that 90% of bleeds were resolved with two or fewer infusions per week. Graphic indicating that 83% of prophylaxis patients assessed treatment of bleeds as 'Excellent' or 'Good'

    *n=112 on prophylaxis.1
    Treatment of bleeds from week 0 through week 36.1
    Two patients discontinued after a single dose of Jivi and were not included in the efficacy analysis.1
    §On a scale of: Excellent, Good, Moderate, Poor.1

    Hear Erik, a Jivi patient, share his experience with Jivi's bleed protection.

    Listen to Chama, a Jivi patient, share his perspective on Jivi's bleed protection.

    Target joint resolution with Jivi® 8

    Results from 82 patients who were in the prophylaxis group in the main study and who continued into the extension study. (median time of 1421 days [range: 700-2071]8)

    Image representing historic target joint resolution. Graphic indicating that 95% of historic target joints were resolved. 107 of 113 historic target joints were resolved at of the time of analysis (data cut-off 8/28/2019). The median target joint ABR was 0 at the end of the main study and 0 at the extension study cutoff date (8/28/2019). The mean target joint ABR was 1.28 at the end of the main study and 1.06 at the extension study cutoff date (8/28/2019).

    Analysis consisted of8:

    • Numbers of historic target joints recorded at study entry
    • Numbers of resolved target joints (≤2 spontaneous bleeds during the last 12 months)
    Image representing historic and new target joint resolution. Graphic indicating that 91% of historic or new target joints were resolved. 111 of 122 historic or new target joints were resolved at of the time of analysis (data cut-off 8/28/2019). The median target joint ABR was 0 at the end of the main study and 0 at the extension study cutoff date (8/28/2019). The mean target joint ABR was 1.28 at the end of the main study and 1.06 at the extension study cutoff date (8/28/2019).

    Analysis consisted of8:

    • Numbers of historic target joints, as judged by the investigator, recorded at study entry
    • Numbers of new target joints that developed on-study (≥3 spontaneous bleeds within 6 months)
    • Numbers of resolved target joints (≤2 spontaneous bleeds during the last 12 months)

    *Patients remaining on the same prophylaxis regimen during the last 90 days of treatment. Median joint ABRs were 0.00 for twice-weekly and 0.00 for every-5-day dosing interval.9
    As defined by the International Society of Thrombosis and Hemostasis (ISTH).8

     

    Jivi® is an extended-half-life rFVIII with unique step-wise dosing & the potential for fewer infusions1,2

    Start simply. For all prophylaxis patients the recommended starting regimen is Jivi twice weekly (30-40 IU/kg). Step up. Based on bleeding episodes, less frequent dosing of Jivi every 5 days (45-60 IU/kg) can be used. Fine tune. Based on bleeding episodes, the dosing frequency may be further adjusted up or down. 8 of 10 patients reduced their dosing frequency versus the pre-study prophylaxis regimen.

    IU, international units; kg, kilograms; rFVIII, recombinant Factor VIII.
    40/47 patients in the every-5-day and twice-weekly dosing arms for whom prior prophylaxis dosing records were available.5

     

    Hear Ryan share why Jivi's step-wise dosing schedule fits his lifestyle.

    Hear Erik share how he was able to reduce his dosing frequency with Jivi.

    Long-term safety data with Jivi® in adolescents and adults1,2,4

    No confirmed cases of inhibitors against Factor VIII occurred. Allergic reactions occurred in 2 out of 134 patients. In 1 patient, the allergic reaction was related to polyethylene glycol (PEG), a component of Jivi. The four most common side effects are headache, cough, nausea, fever. Serious drug-related adverse events occurred in 2 patients (1.7%). No increasing plasma PEG levels over time. Our bodies have known mechanisms for removing PEG. It is excreted through the kidney (via urine) and liver (via feces). Up to more than 5 years of safety data in previously treated patients 12 years of age and older.

    Jivi is indicated for previously treated adolescents and adults aged 12 years and older with hemophilia A.1
    *A Factor VIII inhibitor (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a Factor VIII inhibitor (BU, Bethesda units; mL, milliliters).>1
    In at least 5% of patients.1
    As of January 2018 interim analysis.4,6

    INDICATIONS

    Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

    Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).

    Jivi is not for use in children below 12 years of age or in previously untreated patients.

    Jivi is not used to treat von Willebrand disease.

    IMPORTANT SAFETY INFORMATION

    You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi.

    Tell your healthcare provider about all of your medical conditions that you have or had.

    Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII.

    Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea.

    Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.

    Your body can also make antibodies, called “inhibitors,” against Jivi, which may stop Jivi from working properly. Consult your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

    If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.

    The common side effects of Jivi are headache, cough, nausea, and fever.

    These are not all the possible side effects with Jivi. Tell your healthcare provider about any side effect that bothers you or that does
    not go away.

    For additional important risk and use information, please see the full Prescribing Information.

    References: 1. Jivi ® Prescribing Information. Whippany, NJ: Bayer LLC; 2018. 2. Data on file. Tx Review 0918. Bayer; 2018. 3. Ratain MJ, Plunkett WK Jr. Principles of pharmacokinetics. In: Kufe DW, Pollock RE, Weichselbaum RR, et al, eds. Holland-Frei Cancer Medicine. 6th ed. Hamilton, Ontario: BC Decker; 2003. 4. Reding MT, Ng HJ, Poulsen LH, et al. Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII. J Thromb Haemost. 2017;15(3):411-419. 5. Kerlin BA, Simpson ML, Reding MT, Linardi C, Schwartz L. Comparison of bleeding rates before and during BAY 94-9027 prophylaxis: data from the PROTECT VIII study and extension. Presented at: 4th Biennial Summit of the Thrombosis & Hemostasis Societies of North America; March 8-10, 2018; San Diego, CA. 6. Lalezari S et al. Haemophilia 2019;25:1011-1019. 7. CSRs [main study, extension study] 8. Reding M et al. Poster PB1450. Presented at the 27th International Society on Thrombosis and Haemostasis (ISTH) Congress. 6–10 July 2019, Melbourne, Australia. 9. Reding M et al. Poster P29. Presented at the Hemostasis and Thrombosis Research Society 2019 Scientific Symposium. 9–11 May 2019, New Orleans, Louisiana. 10. Data on file. Jivi PROTECT VIII Extension JAN 2018 CSR ABR data. 11. Data on file. CSR 2.5. Bayer, 2018.