Bayer Kogenate FS
Bayer HealthCare, Biological Products Division

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Safety

History of Proven Safety

Kogenate® FS has a proven safety profile with one of the lowest diluent volumes available. In nearly 18 years of clinical experience, Kogenate® has demonstrated a remarkable history of virus safety with more than 5 billion units infused without a single confirmed case of virus transmission.

With the advent of biotechnology, new standards of virus safety were developed. Because products such as rFVIII are derived from mammalian cell cultures, they fit well within these new standards.

These high standards in virus safety are adhered to during the manufacturing process of Kogenate FS to minimize theoretical risk of virus transmission. The Bayer HealthCare concept behind the manufacturing of Kogenate FS is to achieve a high level of safety without sacrificing tolerability and efficacy.




 
  

Kogenate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the treatment of hemophilia A. The most frequently reported adverse events were local injection site reactions, dizziness, and rash. Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Kogenate® FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate® FS. For important safety and use information, please see the full prescribing information.

Please consult your health care provider prior to making any lifestyle changes. The images used on this site do not necessarily represent actual Hemophilia patients.