Kogenate FS

antihemophilic factor (recombinant) for the treatment of Hemophilia A

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Kogenate® FS with BIO-SET®

(Antihemophilic Factor [Recombinant]) provides real protection for people living with hemophilia A.

As a market leader, Bayer HealthCare recognizes 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.

Kogenate FS with BIO-SET offers real protection for patients with hemophilia A. Whether you are a lifelong Kogenate FS patient, or deciding on the best treatment option for you, we have included information here so that you can be well-informed.

If you have a specific technical or clinical question concerning Kogenate FS, please contact your Hematology Account Executive.

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.

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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

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