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The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to AHF. Continue Reading Below »
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Kogenate® FS with BIO-SET®
antihemophilic factor (recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called "classic" hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.
Kogenate FS is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. If you have hemophilia A, your healthcare provider may give you Kogenate FS when you have surgery.
Kogenate FS can reduce the number of bleeding episodes when used regularly and reduce the risk of joint damage in children.
Kogenate FS is not used to treat von Willebrand's Disease.
As a recognized leader in specialty pharmaceuticals, Bayer HealthCare understands the vital role that Factor VIII treatment plays in each patient's life. Product choice is an individual decision that should be based on an individual's needs. Please consult with your healthcare provider to determine if Kogenate FS is right for you.
Whether you are a lifelong Kogenate FS patient, or deciding on an appropriate treatment option for you, we have included information here so that you can be well informed.
If you have a specific question concerning Kogenate FS, please contact your healthcare provider.
INDICATIONS & USAGE
Kogenate® FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
IMPORTANT SAFETY INFORMATION
The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Kogenate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information, please see the full prescribing information.
© 2010 Bayer HealthCare Pharmaceuticals Inc. All rights reserved.
BAYER, the Bayer Cross, and KOGENATE are registered trademarks of Bayer.
BIO-SET is a trademark of Biodome SAS.
