Formula & Concentration
(Antihemophilic Factor [Recombinant], Formulated with Sucrose)
Kogenate FS is an Antihemophilic Factor (Recombinant) indicated for:
On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
Perioperative management of bleeding in adults and children with hemophilia A.
Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.
Kogenate FS is not indicated for the treatment of von Willebrand disease.
Shelf Life and Storage
Product as Packaged for Sale Store Kogenate FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kogenate FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F. Record the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Do not use Kogenate FS after the expiration date indicated on the vial. Do not freeze. Protect from extreme exposure to light and store the lyophilized powder in the carton prior to use. Product After Reconstitution After reconstitution, store the Kogenate FS solution at room temperature and administer within 3 hours. Use the administration set provided.