FAQ's

What is Kogenate^® FS?
Kogenate^® FS, Antihemophilic Factor (Recombinant), Formulated with Sucrose, is a drug used for the treatment of hemophilia A. Kogenate FS is a recombinant factor VIII preparation that has been manufactured using recombinant DNA technology. The human FVIII gene is introduced into baby hamster kidney cells to produce Kogenate FS in a complex manufacturing process that ensures its safety and purity. The way Kogenate FS works is similar to the way FVIII made from human plasma works.

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How does Kogenate^® FS work?
When a patient infuses Kogenate FS, it works by temporarily replacing the clotting factor missing in hemophilia A (Factor VIII), allowing the blood to clot to stop or prevent bleeding episodes.

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What were the results of the clinical studies performed on Kogenate FS?
There were two studies involving 71 patients with severe hemophilia A who had previously been treated with antihemophilic factor; 38 patients were in North America and 33 were in Europe. The studies were designed to determine the safety and efficacy of Kogenate FS and to demonstrate its similarity in pharmacokinetic behavior to Kogenate^® Antihemophilic Factor (Recombinant), a product that has been used safely and effectively since it was licensed in 1993. In these studies Kogenate FS was used as home treatment and also as prophylaxis prior to surgical procedures. Both studies found Kogenate FS to be safe and effective in controlling bleeding and similar to Kogenate in pharmacokinesis.¹

Other studies were also performed to assess the safety and efficacy of Kogenate FS in previously untreated patients and minimally treated patients. Sixty-one infants and young children with severe hemophilia A (with a FVIII level of less than 2%) were enrolled, and they received over 1,700 prophylactic or on-demand infusions over a period of 45 months. Kogenate FS demonstrated excellent hemostatic response in this study and was found to be safe and effective in infants and young children.²

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How safe is Kogenate^® FS?
A high-quality manufacturing process is used to produce Kogenate FS, ensuring its safety and purity. In the 15 years that Kogenate^® has been used in treating hemophilia A, there has not been a single confirmed case of virus transmission. Kogenate FS has been specially formulated to even further reduce the theoretical risk of virus contamination.

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How is Kogenate^® FS stored and what is the shelf life?
Kogenate® FS may be stored at room temperature for up to 3 months.⁴ Do not freeze Kogenate® FS. Protect the vials from bright light by storing them in their carton before use. The expiration date of each vial of Kogenate® FS is indicated on the bottle.

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What if I have more questions about Kogenate^® FS?
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 or medication. To contact Bayer HealthCare Customer Service in the USA during regular business hours, 8 am - 5pm Eastern Standard Time, call: 1.800.243.4153.

Or click here to e-mail Bayer.

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¹ Abshire TC, Brackmann HH, Scharrer I, et al. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Thromb Haemost. 2000;83(6):811-816.

² Kogenate^® FS [package insert]. Elkhart IN: Bayer HealthCare; 2001. Kogenate^® is a registered trademark of Bayer AG, Germany.

³ Data on File, Bayer HealthCare.

⁴ Refrigerate at 36°F- 46°F (2°C- 8°C). Storage of lyophilized powder at room temperature (up to 25°C or 77°F) for 3 months, such as in home treatment situations, may be done. Do not use after expiration date.