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

Kovaltry®: An unmodified, full length recombinant Factor VIII treatment with a cell bank derived from the Kogenate® FS cell line1

Information for adolescent and adult patients.

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

Kovaltry Prophylaxis Treatment

    Prophylaxis clinical study data

    Kovaltry Clinical Study (62 patients)

    Study Design
    The multinational, open-label, prospective study of previously treated patients aged 12-65 years with severe hemophilia A evaluated efficacy and safety of Kovaltry 2x/week (n=18) or 3x/week (n=44) prophylaxis. The primary efficacy endpoint was annualized bleed rate (ABR) at 12 months.1

    1

    bleed per year
    (median ABR)

    (n=62)4

    Blue zero.

    inhibitors

    in 62 previously treated patients1

    in the completed study of 62 previously treated patients1

    People with hemophilia A may develop inhibitors to rFVIII.1*

    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.

    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.

    ABR, annualized bleed rate.
    FVIII=factor VIII; IU=international units.
    *People with a history of inhibitors were excluded from LEOPOLD.5

    Kogenate FS prophylaxis patients who transitioned to Kovaltry

    22 Kogenate FS patients transitioned to Kovaltry prophylaxis as part of the Kovaltry clinical study.

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

    Green arrow pointing down.

    A reduction in
    bleeds per year    5*

    Blue zero.

    inhibitors5

    in the subgroup analysis of 22 previously treated patients1

    People with hemophilia A may develop inhibitors to rFVIII.1†

      MEDIAN ABR5
    Kogenate FS ABR prior to study enrollment 2.5
    Kovaltry ABR during study 1

    There were no drug-related adverse events in this sub-group during the 12 months of the main trial.

    ABR, annualized bleed rate.
    FVIII=factor VIII; IU=international units.
    *Self-reported bleeds in prior 12 months.5
    †People with a history of inhibitors were excluded from LEOPOLD.5

    Prophylaxis dosing

    Kovaltry offers Kogenate FS patients the opportunity to stay on the same dose and frequency1,3

    Adolescents and Adults
      Kogenate FS Kovaltry  
    Dose 
      25 IU/kg  
    		20 IU/kg   40 IU/kgPotential to stay on the same dose
    Frequency 
    3x per week  
    3x per week 2x per week
    		Potential to stay on the same infusion frequency or reduce frequency

    Adolescents and Adults

    Kogenate FS  Kovaltry 
    Dose  
     
    25 IU/kg
     
    		 20 IU/kg  40 IU/kg

    Potential to stay on the same dose

       
    Frequency  
     
    3x per week
     
    3x per week
    2x per week

    Potential to stay on the same infusion frequency or reduce frequency

    Prophylaxis summary

    Kovaltry offers prophylaxis patients currently on Kogenate FS…

    • A cell bank derived from the Kogenate FS cell line2
    • Advancements to the Kogenate FS manufacturing process, including:1
      • Removal of human and animal derived raw materials from the cell culture
      • Addition of 20nm filtration step
    • The potential to stay on the same dose and frequency1

    In a study analysis, prophylaxis patients who transitioned to Kovaltry from Kogenate FS experienced:5

    Green arrow pointing down.

    A reduction in bleeds per year (ABR)*

    Blue zero.

    inhibitors

    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.

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

    Alt tag

    Click here to download Kovaltry prophylaxis data

    Kovaltry On-Demand Treatment

      On-demand clinical study data

      Kovaltry Clinical Study (21 patients)

      The safety and efficacy of Kovaltry for on-demand treatment in adolescent and adult (12 to 65 years of age) previously treated patients (PTPs) was evaluated for 12 months1,6

      Circular chart.

      95.2%
      of bleeds were treated
      with ≤2 infusions6

      21.6% of total bleeds were trauma bleeds.6

      75.5%
      1 infusion6

      19.7%
      2 infusions6

      4.8%
      3+ infusions6

      21.6% of total bleeds were trauma bleeds.15

      Blue zero.

      inhibitors

      in the main study analysis of 21 previously treated patients.6

      One patient in the on-demand group (n=21) experienced a mild drug-related adverse event (infusion site pruritus).6

      The on-demand arm in the Kovaltry clinical study and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.6

      Kogenate FS on-demand patients who transitioned to Kovaltry

      10 Kogenate FS on-demand patients transitioned to Kovaltry on-demand as part of the clinical study.6

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

      Circular chart.

      96.7%
      of bleeds were treated
      with ≤2 infusions6

      15.9% of total bleeds were trauma bleeds.6

      85.9%
      1 infusion6

      10.8%
      2 infusions6

      3.3%
      3+ infusions6

      15.9% of total bleeds were trauma bleeds.6

      Blue zero.

      inhibitors

      in the subgroup analysis of 10 previously treated patients.6

      There were no drug-related adverse events in the subgroup.7

      The on-demand arm in the Kovaltry clinical study and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.6

      On-demand summary

      Kovaltry offers on-demand patients currently on Kogenate FS…

      • A cell bank derived from the Kogenate FS cell line2
      • Advancements to the Kogenate FS manufacturing process1
        • Removal of human and animal derived raw materials from the cell culture
        • Addition of 20nm filtration step

      In a study analysis, on-demand patients who transitioned to Kovaltry from Kogenate FS experienced:5

      96.7%

      of bleeds treated with ≤2 infusions

      Blue zero.

      inhibitors

      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.

      Alt tag

      Click here to download Kovaltry on-demand data

      For more information about Kovaltry, visit www.Kovaltry.com.

      1. Kovaltry Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2021. 2. Data on file. Kovaltry Summary Basis for Regulatory Action. Bayer HealthCare LLC, Whippany, NJ; 2016. 3. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ. 4. Saxena K, Lalezari S, Oldenburg J, et al. Efficacy and safety of BAY 81-8973, a full-length recombinant factor VIII: results from the LEOPOLD I trial. Haemophilia. 2016;22(5):706-712. 5. Data on file. Leopold I (12954) prior Kogenate FS/Helixate FS cohort. Bayer HealthCare LLC, Whippany, NJ. 6. Data on file. Leopold II (14319) prior OD Kogenate FS/Helixate FS Cohort - Descriptive analysis. Bayer Healthcare LLC, Whippany, NJ. 7. Data on file. Leopold II (14319) prior OD Kogenate FS/Helixate FS Cohort. Bayer Healthcare LLC, Whippany, NJ.

      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.
       

      Kogenate<sup®</sup> FS Antihemophilic Factor (Recombinant) graphic logo. Kogenate<sup®</sup> FS Antihemophilic Factor (Recombinant) graphic logo.
      Kovaltry<sup®</sup> Antihemophilic Factor (Recombinant) graphic logo. Kovaltry<sup®</sup> Antihemophilic Factor (Recombinant) graphic logo.
      Jivi<sup®</sup> Antihemophilic Factor (Recombinant) PEGylated-aucl graphic logo. Jivi<sup®</sup> Antihemophilic Factor (Recombinant) PEGylated-aucl graphic logo.

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      You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

      Site last modified 08/2024

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