Prescribing Information

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 hightiter 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 FS are registered trademarks of Bayer HealthCare Pharmaceuticals.
BIO-SET is a trademark of Biodome SAS.

Kogenate FS Antihemophilic Factor (Recombinant) with BIO-SET Needleless Reconstitution System