SELECTED IMPORTANT SAFETY INFORMATION ABOUT KOGENATE FS, KOVALTRY, AND JIVI 
KOGENATE FS, KOVALTRY, and JIVI are contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins. JIVI is also contraindicated in patients who have a history of hypersensitivity reactions to polyethylene glycol (PEG). ...Continue reading below

Frequently asked questions about the Kogenate® FS discontinuation.

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

General Questions

    Why is Kogenate FS being discontinued?

    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.

    How long will Kogenate FS patients have until they need to transition to a new product?

    The timing of discontinuation will vary by Kogenate FS vial size. Customer demand may lead to depletion of the larger vial sizes of Kogenate FS during the fall of 2022. Remaining Kogenate FS vial sizes are anticipated to be available into 2023. For more information on Kogenate FS availability, please reach out to your Bayer rep here, or call Customer Service at 1-888-606-3780.

    Who can I call at Bayer if I have questions?

    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.

    Are there similarities between Kogenate FS and Kovaltry?

    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

    Does Bayer have an option for patients interested in an extended half-life (EHL) product?

    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

    What should the next steps be for a Kogenate FS patient or caregiver?

    As a next step, patients should discuss their alternative treatment options with their healthcare provider. As a resource for your patient’s transition, we encourage your patients to download this helpful transition guide. You can also click here to reach out to your Bayer rep for information on our additional hemophilia A treatment options and our patient support services.

    Is data available on patients who transitioned from Kogenate FS to Kovaltry or Jivi?

    Please click here to review clinical trial data from the Kovaltry and Jivi clinical trials, including data on Kogenate FS patients who transitioned to Kovaltry or Jivi. This includes data on patients who treated on-demand and patients who treated with prophylaxis.

    Is patient support available for Kogenate FS patients transitioning to Kovaltry or Jivi?

    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‡§.

    Can Kogenate FS patients try Kovaltry or Jivi before committing to a longer-term switch?

    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. Click here to learn more about how to enroll your patients in the Free Trial Program¶#.

    • Your Bayer rep can also provide Healthcare Providers with in-office trial vials of Kovaltry and Jivi. Please reach out to your Bayer rep here for additional information on this program.
    I need to order Kogenate. How do I find out how much inventory is remaining, by vial size?

    For more information on remaining inventory for Kogenate FS, please reach out to your Bayer rep here, or call Customer Service at 1-888-606-3780.

    Additional FAQs

    Questions about Kovaltry Questions about Jivi Insurance Questions

    *Formulary status is believed to be accurate as of January 1, 2022 but cannot be guaranteed. Formulary status for national plans may not reflect plan variation at the local level. Lower co-pay costs do not necessarily reflect a cost advantage in the outcome of the condition treated because there are other variables that affect relative cost. Formulary status does not imply a comparison of efficacy, safety, or dosing.

    †Jivi coverage includes pharmacy and medical lives across commercial (99%), fee-for-service Medicaid (100%), Managed Medicaid (100%) & Medicare Advantage (100%). Percentage represents the coverage within the book of business. n=1,518, 51, 369, 748. Kovaltry coverage includes pharmacy and medical lives across commercial (99%), fee-for-service Medicaid (100%), Managed Medicaid (100%) & Medicare Advantage (100%). Percentage represents the plan coverage within the book of business: n=1,798; 51; 410; 1,112.

    ‡Patients who are enrolled in any type of government insurance are not eligible. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.

    §Co-pay program support is available for up to 1 year. Can include any out-of-pocket prescription costs, such as co-pay and co-insurance. Up to $20,000 in co-pay assistance available per year. Eligible patients will be auto-enrolled every January.

    ¶The medication provided through this program is at no cost to the patient and is not contingent on future use of this medication. Reselling or billing any third party for free product provided by this program is prohibited by law.

    #Participation in the Jivi or Kovaltry Free Trial Program is limited to 1 time only per product (patients currently using Jivi or Kovaltry are not eligible for a Free Trial of their current product). The Free Trial Program includes 1 month supply up to a maximum of 40,000 IU. The Free Trial Program for Jivi is available to patients 12 years of age and older. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.

    1. Kovaltry Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2021. 2. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ. 3. Jivi Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2018.

    Indications and Important Safety Information

    Indication For KOGENATE® FS

    KOGENATE FS is an Antihemophilic Factor (Recombinant) indicated for:

    • On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
    • Perioperative management of bleeding in adults and children with hemophilia A.
    • Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
    • Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.

    Indication For KOVALTRY®

    KOVALTRY Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for:

    • On-demand treatment and control of bleeding episodes
    • Perioperative management of bleeding
    • Routine prophylaxis to reduce the frequency of bleeding episodes

    Indication For JIVI®

    JIVI antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:

    • On-demand treatment and control of bleeding episodes
    • Perioperative management of bleeding
    • Routine prophylaxis to reduce the frequency of bleeding episodes

    Limitations of Use For JIVI:

    • JIVI is not indicated for use in children
      less than 12 years of age due to a greater risk for hypersensitivity reactions.
    • JIVI is not indicated for use in previously untreated patients (PUPs).

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

    Important Safety Information About KOGENATE FS, KOVALTRY, and JIVI

    • KOGENATE FS, KOVALTRY, and JIVI are contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins. JIVI is also contraindicated in patients who have a history of hypersensitivity reactions to polyethylene glycol (PEG).
    • Hypersensitivity reactions, including severe allergic reactions, are possible with KOGENATE FS, KOVALTRY, and JIVI. Monitor patients for hypersensitivity symptoms. 
      Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOGENATE
      FS, KOVALTRY, or JIVI if symptoms occur and seek immediate emergency treatment.
    • KOGENATE FS, KOVALTRY, and JIVI may contain trace amounts of mouse and hamster proteins. Patients treated with KOGENATE FS, KOVALTRY, or JIVI may develop hypersensitivity to these non-human mammalian proteins.
    • Neutralizing antibodies (inhibitors) have occurred following administration of KOGENATE FS, KOVALTRY, and JIVI predominately in previously untreated patients. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, suspect the presence of an inhibitor.
    • For JIVI, a clinical immune response associated with IgM anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed primarily in patients < 6 years of age. The symptoms of the clinical immune response were transient. Anti-PEG IgM titers decreased over time to undetectable levels. No immunoglobulin class switching was observed. In case of clinical suspicion of loss of drug effect, conduct testing for Factor VIII inhibitors and Factor VIII recovery.
    • For JIVI, a low post-infusion Factor VIII level in the absence of detectable Factor VIII inhibitors indicates that loss of drug effect is likely due to anti-PEG antibodies. Discontinue JIVI and switch patients to a previously effective Factor VIII product.
    • Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII.
    • Catheter-related infections may occur when KOVALTRY is administered via central venous access devices (CVADs). These infections have not been associated with the product itself.

    In clinical trials with:

    • KOGENATE FS – the most common adverse reactions (≥4%) observed were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and CVAD-associated infections.
    • KOVALTRY – the most frequently reported adverse reactions in clinical trials (≥5%) were inhibitors in previously untreated patients (PUPs)/minimally treated patients (MTPs), and pyrexia, headache, and rash.
    • JIVI – the most frequently (≥5%) reported adverse reactions in previously treated patients (PTPs) ≥12 years of age were headache, cough, nausea, and fever.

    For additional important risk and use information, please see the full Prescribing Information for KOGENATE FS, KOVALTRY, and JIVI.

    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.

    © 2022 Bayer. All rights reserved. Bayer, the Bayer Cross, Kogenate FS, Kovaltry and Jivi are registered trademarks of Bayer. Access Services by Bayer is a trademark of Bayer.

    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 5/22

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