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

Frequently asked questions about the Kogenate® FS discontinuation.

See additional questions about Kovaltry®, Jivi® and insurance below.

General Questions

    Bayer has made the decision to discontinue Kogenate FS due to the growing shift in patient use away from older standard half-life products, such as Kogenate FS, towards more recent standard and extended half-life products, such as Kovaltry and Jivi.

    The timing of discontinuation will vary by Kogenate FS vial size. Customer demand may lead to depletion of the larger vial sizes during the fall of 2022. Remaining Kogenate FS vial sizes are anticipated to be available into 2023. Reach out to your factor provider (HTC or Specialty Pharmacy) for more information on Kogenate FS availability.

    The timing of discontinuation will vary by Kogenate FS vial size. Customer demand may lead to depletion of the larger vial sizes during the fall of 2022. Remaining Kogenate FS vial sizes are anticipated to be available into 2023. Reach out to your factor provider (HTC or Specialty Pharmacy) for more information on Kogenate FS availability.

    Our Bayer team is dedicated to ensuring a smooth transition for current Kogenate FS patients, caregivers, and healthcare providers. Call our dedicated Kogenate FS Hotline at 833-40-BAYER to speak to a product specialist for additional information. Your dedicated Bayer rep is also available to answer questions you may have. To get in touch with your Bayer rep, please click here.

    Yes, like Kogenate FS, Kovaltry is an unmodified, full-length, standard half-life (SHL) Factor VIII product from Bayer, and offers patients the opportunity to stay on the same dose and frequency of infusions as well as the potential to reduce their dosing frequency. The Kovaltry manufacturing process starts with a cell bank derived from the Kogenate FS cell line, and incorporates advancements to the Kogenate FS manufacturing process which include the removal of human – and animal – derived raw materials from the cell culture and the addition of the 20nm filtration step. Kovaltry is indicated for adults and children with hemophilia A.1,2 Please speak with your doctor about any changes to your treatment plan.

    Yes, Jivi, is an extended half-life (EHL) product offering adult and adolescent patients a twice-weekly starting dose and, based on bleeding episodes, the potential to step up to every 5 days and fine tune. Jivi is indicated for use in previously treated adult and adolescent patients, 12 years of age or older, with hemophilia A and not for use in patients under 12 years of age or in previously untreated patients.3 Talk to your doctor to see if Jivi might be right for you.

    As a next step, please talk to your healthcare provider about alternative treatment options, including whether Jivi or Kovaltry may be right for you. As a guide for your discussion with your doctor, download the Transition Guide to make sure you’re prepared for the discussion. You can also click here to reach out to your Bayer rep for information on our additional hemophilia A products and our patient support services. 

    Schedule an appointment with your doctor to discuss whether Kovaltry, a standard half-life (SHL) product for pediatric, adolescent and adult patients, or Jivi, an extended half-life (EHL) product for adolescent and adult patients, may be right for you based on your needs. For a helpful guide to use during your visit with your doctor, please download the Transition Guide.

    Like Kogenate FS, both Kovaltry and Jivi can be used to treat on-demand and prophylactically.1,2,3  It’s important to talk to your doctor about which product and treatment may be right for you based on your individual needs. Click here to download a Transition Guide to assist in your discussion with your doctor about alternative treatment options. 

    Yes, patients have transitioned from Kogenate FS to Kovaltry or Jivi. All patient experiences are different, which is why it is important to discuss your individual treatment plan with your doctor.   

    • Click here to watch Ryan Moulton, a hemophilia A patient, tell his story of transitioning from Kogenate FS, to Kovaltry, and then to Jivi.
    • Hear more firsthand stories from Kovaltry patients at KovaltryConversations.com.
    • Hear more firsthand stories from Jivi patients at MyJourneytoJivi.com.
    • Learn more about clinical studies of Kovaltry and Jivi, which included patients who transitioned from Kogenate FS.

    Please click here to explore data from the Kovaltry and Jivi clinical studies, including data on Kogenate FS patients who transitioned to Kovaltry or Jivi. Remember to always work with your doctor on any changes to your treatment plan.

    Bayer realizes that insurance coverage and patient support programs play an important role when transitioning products. Kovaltry and Jivi are currently covered for 99% of patients nationally.* Most Kogenate FS patients who transition to Jivi or Kovaltry can receive either product at little to no out of pocket cost, through the Access Services by Bayer program‡§. Access Services by Bayer provides a Patient Loyalty program‡¶, Free Trial program¶#, $0 Co-Pay program‡§, and reimbursement for lab testing‡§.

    Yes, Kogenate FS patients who would like to try Kovaltry or Jivi can receive 1 month of free therapy delivered right to their home through the Free Trial Program. Any patient new to Kovaltry or Jivi can participate, regardless of insurance type or status. Talk to your doctor and click here to learn more about how to enroll in the Free Trial Program.¶#

    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.