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
Do you have patients currently on Kogenate® FS? We're here to provide the information you need.
Bayer recently announced that Kogenate FS will be discontinued. During this transition period, Bayer is committed to providing support and resources that ensure healthcare providers feel confident in helping their Kogenate FS patients navigate the next steps in their treatment plan.
Click here for the Kogenate FS Discontinuation Announcement from Bayer.
For more information on the Kogenate FS discontinuation click below.
Treatment options for your patients from Bayer.
Bayer offers additional rFVIII products:
Kovaltry®
For children
Learn moreFor adults and adolescents
Learn moreJivi®
For adults and adolescents ≥12
Learn moreKogenate FS (to be discontinued)
Kovaltry
Jivi
About
Kogenate FS1 is an unmodified, full length recombinant factor VIII treatment
Kovaltry2 is the only unmodified full length recombinant factor VIII treatment offering the potential for as few as 2 infusions per week
Jivi3 is the extended half-life rFVIII with proven protection, safety and unique step-wise dosing
FDA Approval
1993
2016
2018
Indicated Age Groups
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
Extended half-life
Prophylaxis Dosing Highlights
3 times a week dosing in adults and every other day in children
Potential for twice-weekly dosing
Twice-weekly starting dose, with the potential to step up to every 5 days and fine tune
Cell Line
Same type of cell line
Reconstitution System
Same vial adapter reconstitution device
Kogenate FS1
(to be discontinued)
(to be discontinued)
Kovaltry2
Jivi3
About
Unmodified, full length rFVIII
Unmodified, full length rFVIII offering the potential for 2x weekly infusions
EHL rFVIII with unique step-wise dosing
FDA Approval
1993
2016
2018
Indicated Age Groups
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
Not for use in children under 12 years of age or in previously untreated patients
Half-Life
Standard half-life
Extended half-life
Prophy-laxis Dosing Highlights
3 times a week dosing in adults and every other day in children
Potential for twice-weekly dosing
Twice-weekly to start, with potential to step up to every 5 days and fine tune
Cell Line
Same type of cell line
Recon-stitution System
Same vial adapter reconstitution system
Sign up to stay up to date on the latest information regarding the Bayer hemophilia A portfolio, patient support programs and more.
Sign up today1. 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
ISI v2 - Important Safety Information v3
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.
