FAQ
- What is Kogenate® FS?
- How does Kogenate® FS work?
- What were the results of the clinical studies performed
on Kogenate® FS?
- How safe is Kogenate® FS?
- How is Kogenate® FS stored and what is the shelf life?
- Is it true that you use the same 2.5 mL diluent volume for all doses?
- What if I have more questions about Kogenate® FS?
What is Kogenate® FS?
Kogenate® FS, Antihemophilic Factor (Recombinant), Formulated with Sucrose, is a prescription medicine used for the treatment of hemophilia A. The full-length Kogenate® FS molecule is a large recombinant protein that acts much like naturally occurring FVIII to stop or prevent bleeding.1 The preparation of this recombinant factor VIII treatment involves recombinant DNA technology and a complex manufacturing process that ensures its quality and safety.
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How does Kogenate® FS work?
When a patient infuses Kogenate® FS, it works in a way that is similar to how the FVIII made from human plasma works, temporarily replacing the missing clotting factor (factor VIII), that seals a wound site and stops the bleeding.
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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 intended to determine the safety and efficacy of Kogenate® FS and to demonstrate its similarity 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 for at-home treatment of bleeding episodes and via prophylaxis prior to surgical procedures, for the prevention of bleeds. Both studies found Kogenate® FS to be safe, effective, and similar to Kogenate® in controlling bleeding.2
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 continuous 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.3
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How safe is Kogenate® FS?
A high-quality manufacturing process is used to produce Kogenate® FS, ensuring its safety. 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 exposure.
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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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Is it true that you use the same 2.5 mL diluent volume for all doses?
Following purification, the sterile, filtered solution of Kogenate® FS, containing sucrose, salts, and amino acids is placed in vials in the proper amount according to dose and is then freeze-dried under sterile conditions. Whether you need 250, 500, or 1000 International Units of rFVIII, you use 2.5 mL of diluent (sterile water) to reconstitute the dose. Once reconstituted, the amount of liquid in the vial is the same (2.5 mL), regardless of dose. This directly benefits you, the patient, because with a smaller volume to infuse, infusions go more quickly.
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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 Customer Service in the USA during regular business hours, 8 am - 5pm Eastern Standard Time call: 1.800.243.4153.
Or Contact Customer Service.
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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.
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1 Bodekar BG. The manufacturing of recombinant FVIII. Kogenate Med 1992;6(4):256-260.
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2 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.
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3 Auerswald G, Lusher J, Kreuz W, et al. Outcome of a prospective, multinational clinical trial in children treated with a full-length, sucrose formulated rFVIII product. Ann Hematol 2003; 82: S11.
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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.
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