SELECTED IMPORTANT SAFETY INFORMATION ABOUT JIVI, KOVALTRY, AND KOGENATE FS
You should not use JIVI, KOVALTRY, or KOGENATE FS if you are allergic to rodents (like mice and hamsters) or any ingredients in JIVI, KOVALTRY, or KOGENATE FS. ...Continue reading below

Jivi®: Powerful protection from bleeds with a twice-weekly starting dose and the potential to step up to every 5 days and fine tune2

Jivi is indicated for previously treated patients aged ≥12 years.2

Explore data below on Kogenate® FS patients who transitioned to Jivi as part of a clinical trial.

Jivi Prophylaxis Treatment

    Proven efficacy and safety in adults and adolescents (12 years of age and older) who participated in the Jivi Clinical Study (n=112)#

    Study design
    110 prophylaxis patients completed a 10-week run-in period where they received 25 IU/kg twice weekly. They were then assigned or randomized to a treatment arm based on bleeding tendency (low or high). Among patients with low bleeding tendencies, 11 received 30-40 IU/kg twice weekly and 43 patients received 45-60 IU/kg every 5 days for 26 weeks, 13 patients with high bleeding tendencies received 30-40 IU/kg twice weekly for 26 weeks.

      TOTAL ABRSPONTANEOUS ABR
     Bleeding Tendency2MedianMeanMedianMean
    TWICE WEEKLY2LOW*1.92.201.2
    HIGH†¶4.17.2
    Reduced from 17.4 ABR2
    3.93.9
    EVERY 5 DAYS2LOW*1.93.301.8
    COMBINED (n=67)22.13.9 

    inhibitors2 in the completed study*5

    ‡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.2

    • The common side effects of Jivi are headache, cough, nausea, and fever.
    • Allergic reactions occurred in 2 patients. In 1 patient, the allergic reaction was related to polyethylene glycol (PEG), a component of Jivi.

    ABR, annualized bleed rate.
    *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.3
    †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.3
    ‡June 2014 data cutoff.
    §n=9/13 of these patients were on prior prophylaxis and had a mean number total ABR of 17.4 before entering the main study.3
    ¶n=11; n=13 (twice weekly: low; high).2
    #112 patients entered prophylactic treatment arms. Two patients enrolled in the prophylactic arms left the main study prematurely during the run-in period.

    21 adolescent and adult Kogenate FS patients (12 years of age or older) transitioned to Jivi prophylaxis as part of the 26 week Jivi Clinical study. In an analysis of study data completed after the study ended, it was determined that Kogenate FS patients who transitioned to Jivi experienced:

    Blue and white down arrow: Bayer Products.

    A reduction in ABR*

    Zero.

    inhibitors6

      MEDIAN ABR6 MEAN ABR6
    Kogenate® FS ABR prior to study enrollment 9 10.5
    Jivi® ABR during study 2.1 5.2
    Kogenate® FS patients experienced fewer annual bleeds after transitioning to Jivi

    ~67% of patients previously on Kogenate FS were on an every-5-day Jivi regimen in the study

    A drug-related adverse event was reported in one patient. There were no serious drug related adverse events.

    ABR, annualized bleed rate.
    *Self-reported bleeds in prior 12 months.6
    §June 2014 data cutoff.

      FOR PATIENTS ≥ 12 YEARS
    Start Simply
    TWICE
    WEEKLY
    For all prophylaxis patients: Recommended starting regimen is Jivi twice weekly (30-40 IU/kg)2
    Step Up
    EVERY
    5 DAYS
    Based on bleeding episodes: Less frequent dosing of Jivi every 5 days (45-60 IU/kg) can be used2
    Fine Tune
    Up and down arrows: Jivi antihemophilic factor (recombinant) PEGylated-aucl dosing: Bayer Products.
    Based on bleeding episodes: The dosing frequency may be further adjusted up or down2

    2.2 lbs. = 1 kgs

    Sample Starting Dosing Calendar
    SUN
    MON
    TUE
    WED
    THURS
    FRI
    SAT

    Jivi offers prophylaxis adolescent and adult patients currently on Kogenate FS...

    • Powerful protection from bleeds with a twice-weekly starting dose and the potential to step up to every 5 days and fine tune2
    • A demonstrated safety profile in previously-treated adolescents and adults4,6
    • The potential for fewer infusions5 
      • 8/10 patients in the Jivi clinical study reduced their dosing frequency vs. their pre-study prophylaxis regimen

    In a study analysis, prophylaxis patients who transitioned to Jivi from Kogenate FS experienced:6

    Blue and white down arrow: Bayer Products.

    A reduction in bleeds per year (ABR)*

    Zero.

    inhibitors

    ~67% of patients previously on Kogenate FS were on an every 5-day Jivi regimen in the study

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

    ABR, annualized bleed rate.
    *Self-reported bleeds in prior 12 months.6

    Alt tag

    Click here to download Jivi prophylaxis data

    Jivi On-Demand Treatment

      Jivi Clinical Study (20 patients)

      The safety and efficacy of Jivi for on-demand treatment in adolescent and adult (12 to 65 years of age) previously treated patients (PTPs) was evaluated for 36 weeks.2,7

      On-demand clinical study data Circle

      Circular chart.

      91.2%
      of bleeds were treated
      with ≤2 infusions7

      40.4% of total bleeds were trauma bleeds.7

      79.5%
      1 infusion7

      11.7%
      2 infusions7

      8.8%
      3+ infusions7

      40.4% of total bleeds were trauma bleeds.7

      Zero.

      inhibitors

      in the main study analysis of 20 previously treated patients.7

      One patient in the on-demand group (n=20) experienced mild drug-related adverse events (dry mouth, musculoskeletal discomfort).7

      The on-demand arm in the Jivi clinical study and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.8

      10 Kogenate FS on-demand patients transitioned to Jivi on-demand as part of the clinical study.7

      In an analysis of the clinical study data completed after the study ended, it was determined that in Kogenate FS patients who transitioned to Jivi:

      Kogenate FS on-demand patients who transitioned to Jivi

      Circular chart.

      90.6%
      of bleeds were treated
      with ≤2 infusions7

      36.0% of total bleeds were trauma bleeds.7

      73.9%
      1 infusion7

      16.7%
      2 infusions7

      9.4%
      3+ infusions7

      36.0% of total bleeds were trauma bleeds.7

      Zero.

      inhibitors

      in the subgroup analysis of 10 previously treated patients.7

      One patient in the on-demand subgroup (n=10) experienced mild drug-related adverse events (dry mouth, musculoskeletal discomfort).8

      The on-demand arm in the Jivi clinical study and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.8

      Jivi offers on-demand adolescent and adult patients currently on Kogenate FS...

      • Effective treatment of bleeds4,6
      • A proven safety profile4,6

      In a study analysis, on-demand patients who transitioned to Jivi from Kogenate FS experienced:7

      90.6%

      of bleeds treated with ≤2 infusions

      Zero.

      inhibitors

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

      Alt tag

      Click here to download Jivi on-demand data

      For more information about Jivi, including data from the Jivi extension study and details on Jivi's PK coverage, visit www.ExploreJivi.com.

      1. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ. 2. Jivi Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2018. 3. Reding MT et al. J Thromb Haemost 2017; 15:411-419. 4. Lalezari S et al. Haemophilia 2019;25:1011-1019. 14. Data on file. Tx Review 0918, Bayer; 2018. 5. Kerlin BA et al. Poster P153. Presented at the 4th Biennial Summit of the Thrombosis & Haemostasis Societies of North America. March 8-10, 2018, San Diego, California. 6. Data on file. Jivi Protect VIII Subgroup Analysis. Bayer HealthCare LLC, Whippany, NJ. 7. Data on file. Protect VIII (13024) prior OD Kogenate FS/Helixate FS Cohort Descriptive Analysis. Bayer Healthcare LLC, Whippany, NJ. 8. Data on file. Jivi Protect FVIII (13024) Subgroup- prior Kogenate FS/Helixate FS Cohort. Bayer Healthcare LLC, Whippany, NJ.

      ISI v2 - Important Safety Information v3

      Indications and Important Safety Information

      JIVI®, KOVALTRY®, and KOGENATE® FS are injectable medicines used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

      Indication For JIVI®

      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.

      Indication For KOVALTRY®

      KOVALTRY is used to treat and control bleeding in adults and children with hemophilia A. KOVALTRY can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis). Your healthcare provider may give you KOVALTRY when you have surgery.

      Indication For Kogenate® FS

      KOGENATE FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you KOGENATE FS when you have surgery. KOGENATE FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). KOGENATE FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.

      JIVI, KOVALTRY, and KOGENATE FS are not indicated for the treatment of von Willebrand disease.

      Important Safety Information About JIVI, KOVALTRY, and KOGENATE FS

      • You should not use JIVI, KOVALTRY, or KOGENATE FS if you are allergic to rodents (like mice and hamsters) or any ingredients in JIVI, KOVALTRY, or KOGENATE FS.
      • Tell your healthcare provider about all the medical conditions that you have or had or are at risk of such as heart disease. 
      • Allergic reactions may occur with JIVI, KOVALTRY, and KOGENATE FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, dizziness, difficulty breathing, decrease in blood pressure, and nausea.
      • Allergic reactions to polyethylene glycol (PEG), a component of JIVI, are possible.
      • Your body can also make antibodies, called “inhibitors,” against JIVI, KOVALTRY, and KOGENATE FS, which may stop JIVI, KOVALTRY, and KOGENATE FS 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, KOVALTRY, or KOGENATE FS consult your doctor immediately. You may have developed Factor VIII inhibitors to JIVI, KOVALTRY, or KOGENATE FS. If your bleeding is not being controlled with your usual dose of JIVI you may have developed 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.
      • The common side effects of KOVALTRY are fever, headache, and rash, in addition to inhibitors in patients who were not previously treated or minimally treated with Factor VIII products.
      • Other common side effects of KOGENATE FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device.
      • These are not all the possible side effects with JIVI, KOVALTRY, and KOGENATE FS. 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 full Prescribing Information for Jivi, Kovaltry and Kogenate FS.