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

We’re here to support you during this transition.

Bayer recently announced that Kogenate FS will be discontinued. We want patients and their caregivers to know that we are here to support you during this transition. However, it's important to work with your healthcare provider as you consider transitioning products.

More Information

Read the Kogenate FS Discontinuation Announcement from Bayer.

View Announcement

Transition Guide

Use this guide to assist in your discussion with your doctor about treatment options.

Download guide

Questions

Review questions about the Kogenate FS discontinuation, as well as information about Kovaltry® and Jivi®.

View FAQs

Kovaltry and Jivi are available to meet the needs of patients currently taking Kogenate FS. Talk to your healthcare provider about which product might be right for you.

Kovaltry

All children, adolescent, and adult patients currently taking Kogenate FS who would like a rFVIII product with similarities to Kogenate FS should talk to their healthcare provider about transitioning to Kovaltry.

For children

Learn more

For adults and adolescents

Learn more

Jivi

All adult and adolescent patients (12 and older) currently taking Kogenate FS who are interested in an extended half-life (EHL) product should talk to their healthcare provider about transitioning to Jivi.

For adults and adolescents ≥12

Learn more
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Patient Stories

Hear from patients who have already transitioned from Kogenate FS to Kovaltry or Jivi.

Click here to hear patient stories.

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Your Bayer Rep

Find your Bayer Rep, who can answer any questions you may have about the transition and steps you can take to find your next treatment.

Click here to locate the Bayer Rep nearest to you. 

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Insurance Support

Most Kogenate FS patients who transition to Kovaltry or Jivi can receive either product at little to no out-of-pocket cost, through the Access Services by Bayer program.*†

Click here to learn more about our Patient Support options.

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Call Bayer

Call our dedicated Kogenate FS Hotline. Live helpline support is available 8:30 AM - 8:00 PM ET Monday-Friday.

Call 833-40-BAYER

Kovaltry and Jivi are 100% covered under the Medicare medical benefit nationally¶#

*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.
†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.
‡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. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.
§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.
¶Formulary status is believed to be accurate as of March 14, 2024 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 and Kovaltry 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.

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.

© 2024 Bayer. All rights reserved. Bayer, the Bayer Cross, Kogenate, 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 08/2024

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