Bayer Kogenate FS

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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. Kogenate^® FS also offers a proven patient safety and tolerability profile in clinical trials.

Safety in Manufacturing and Formulation
Kogenate^® FS is the result of an innovative, high-quality manufacturing process. To reduce the risk of virus exposure (such as Hepatitis B virus, Hepatitis C virus, and human immunodeficiency virus (HIV)), Bayer research scientists developed a new formulation for Kogenate^® FS that uses sucrose (sugar) instead of human albumin to stabilize the rFVIII protein.

Proven Safety and Tolerability Profile
Kogenate^® FS has a proven safety profile in patients who have not been previously treated for hemophilia and in those who have been previously treated, with 99.9% of all infusions in clinical trials (nearly 35,000 infusions) administered without any drug-related adverse events.¹

Remember, your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor if you have any questions about your health, your symptoms, or your therapy.

¹ Abshire TC, Brackmann HH, et al. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Results of a multicenter, international, clinical investigation. Thrombo Haemost. 2000;83:811-816.

² Data on File, Bayer HealthCare, MRR 1603.

³ Data on File, Bayer HealthCare, PH 31866.

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.