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

Delivering treatment options for hemophilia A patients and their families

Bayer has been a committed presence in the hemophilia A community, developing and distributing products for many years.

Over 4 billion units of Kovaltry and over 500 million units of Jivi have been sold globally.4

Kogenate FS, Kovaltry, and Jivi at a glance

  Kogenate FS1 (to be discontinued) Kovaltry2 Jivi3
FDA Approval 1993 2016 2018
Who It's For (indicated age groups)

 Pediatric, adolescent and adult patients (0 - 65+) 

 Pediatric, adolescent and adult patients (0 - 65+) 

 Adolescent and adult patients (12 - 65+) Not for use in children under 12 years of age or in previously untreated patients
Half-Life

 Standard half-life (SHL) 

 Extended half-life (EHL)
How It's Dosed (prophylaxis highlights) Adults/Adolescents: 3 times weekly Children: Every-other-day Adults/Adolescents: 3 times weekly or twice weekly Children: Every-other-day, 3 times weekly or twice-weekly Twice-weekly starting dose, with the potential (based on bleeding episodes) to step up to every 5 days and fine tune
Recon-stitution System

 Vial Adapter reconstitution device 

 25-gauge butterfly needle and pre-filled diluent syringe 

 25-gauge butterfly needle and pre-filled diluent syringe 
Cell Line

 Same type of cell line 

Bayer offers the hemophilia A community a variety of products, programs and services designed for patients and caregivers. Talk with your doctor about which product might be right for you.

Kovaltry

For children

Learn more

For adults and adolescents

Learn more

Jivi

For adults and adolescents ≥12

Learn more

1. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ. 2. Kovaltry Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2021. 3. Jivi Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2018. 4. Data on file.

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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