Frequently Asked Questions
These FAQs provide a quick snapshot of information that can be most helpful to people who want to know the basics. We have provided some basic information here about Kogenate® FS treatment for quick reference.
Questions
- What is Kogenate FS Treatment?
- How does Kogenate FS work?
- What were the results of the clinical studies performed on Kogenate FS recombinant factor VIII?
- How safe is Kogenate FS treatment?
- How is Kogenate FS treatment stored and what is the shelf life?
- How much diluent is used to reconstitute Kogenate FS treatment?
- What if I still have questions about Kogenate FS treatment?
Answers
What is Kogenate FS Treatment?
Kogenate FS, Antihemophilic Factor (Recombinant), 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, state-of-the-art manufacturing process that ensures its quality and safety.
How does Kogenate FS work?
When a patient infuses Kogenate FS treatment, it temporarily replaces the missing clotting factor (factor VIII), that seals a wound site and stops the bleeding.
What were the results of the clinical studies performed on Kogenate FS recombinant factor VIII?
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 treatment and to demonstrate its similarity to Kogenate FS Antihemophilic Factor (Recombinant), a product that has been used safely and effectively since it was licensed in 1993. In these studies Kogenate FS treatment 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 treatment to be safe, effective, and similar to Kogenate FS in controlling bleeding.2
Other studies were also performed to assess the safety and efficacy of Kogenate FS treatment 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
How safe is Kogenate FS treatment?
Bayer HealthCare uses state-of-the-art manufacturing processes including a multistep purification process that ensures Kogenate FS meets the highest possible product safety standards. Kogenate FS treatment has been specially formulated to even further reduce the theoretical risk of virus exposure.
How is Kogenate FS treatment stored and what is the shelf life?
Kogenate FS product should be stored under refrigeration (2°C-8°C; 36°F-46°F). However, storage of lyophilized powder at room temperature (up to 25°C or 77°F) for up to 3 months, such as in home treatment situations, is acceptable. Freezing must be avoided. Protect the vials from bright light by storing them in their carton before use. Do not use Kogenate FS beyond the expiration date indicated on the vial, or 3 months from the time the product was first removed from refrigeration, whichever comes first. This information pertains to Kogenate FS whether supplied as Kogenate FS with BIO-SET® or in conventional vials.
How much diluent is used to reconstitute Kogenate FS treatment?
Kogenate FS uses one of the smallest diluent volumes available. 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. If you need 250, 500, or 1000 International Units (IU) of rFVIII, you use 2.5 mL of diluent (sterile water) to reconstitute the dose. To reconstitute 2000 IU, you use a 5.0 mL diluent. The small volume diluents may help infusions go more quickly.
What if I still have questions about Kogenate FS treatment?
If you still have questions, contact Bayer HealthCare. Bayer HealthCare welcomes your questions, comments and feedback. We have two ways for you to contact us: by having a local Hematology Account Executive contact you directly, or by submitting the feedback form through this site.
Do not use the contact information on this Web site for medical emergencies. In an emergency, please dial 9-1-1. For non-emergency medical information or to report an adverse event involving Kogenate FS, please contact Bayer HealthCare’s Medical Communications at 1-888-84-BAYER (1-888-842-2937). 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.
References:
- Bodekar BG. The manufacturing of recombinant FVIII. Kogenate Med 1992;6(4):256-260.
- 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.
- 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.
