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 general topics, Kovaltry® and Jivi® below.

Insurance Questions

    Are Kovaltry® and Jivi® covered by my insurance?

    Jivi and Kovaltry are covered by the majority of insurance plans and for 99% of patients nationally.*† Please check with your insurance plan administrator for specific plan details. Access Services by Bayer can also assist your healthcare provider in the process required to get you started on Kovaltry or Jivi. Please have your healthcare provider call Access Services by Bayer at 1-800-288-8374.

    Will my out-of-pocket costs change?

    Bayer offers patients the same $0 Co-Pay Program for Kogenate FS, Kovaltry, and Jivi. By enrolling in the $0 Co-Pay Program, most commercially insured patients can receive Jivi or Kovaltry for as little as $0 per prescription, regardless of income (up to $20,000 in out‑of‑pocket cost assistance is available per year).‡§  Click here to learn more about how to enroll, or call Access Services by Bayer at 1-800-288-8374.

    Can Bayer assist with any costs associated with transitioning to Kovaltry or Jivi?
    • Through the Free Trial Program, patients new to Kovaltry or Jivi can receive 1 month of free therapy, delivered to your home, regardless of insurance type or status.¶#
    • Through the Patient Loyalty Program, Bayer is committed to helping you start and stay on therapy regardless of changes in your commercial health insurance coverage status. Eligible Kogenate FS patients who transition to Jivi or Kovaltry can receive product at no cost if you experience gaps or changes with insurance coverage.‡¶
    • Click here to learn more about how to enroll, or call Access Services by Bayer at 1-800-288-8374.
    What if I already hit my deductible before transitioning products? How does that impact cost?

    Changing products shouldn’t impact your deductible, but please contact your insurance company for additional information related to coverage benefits.

    Will I need a new prior authorization if I transition to Kovaltry or Jivi?

    A new prior authorization is likely needed when a patient transitions to another hemophilia A treatment. However, this is specific to the insurance plan requirements. Access Services by Bayer can assist your healthcare provider in the process required to get you started on Kovaltry or Jivi. Please have your healthcare provider call Access Services by Bayer at 1-800-288-8374.

    Additional FAQs

    General Questions Questions about Kovaltry Questions about Jivi

    *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.

    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 4/23

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