Formula & Concentration
antihemophilic factor (recombinant)
XYNTHA is a recombinant antihemophilic factor indicated in adults and children with hemophilia A for control and prevention of bleeding episodes and for perioperative management. (1)
XYNTHA is not indicated in patients with von Willebrand’s disease. (1)
Shelf Life and Storage
Store XYNTHA under refrigeration at a temperature of 2° to 8°C (36° to 46°F) for up to 36 months from the date of manufacture until the expiration date stated on the label. Within the expiration date, XYNTHA also may be stored at room temperature not to exceed 25°C (77°F) for up to 3 months. After room temperature storage, XYNTHA can be returned to the refrigerator until the expiration date. Do not store XYNTHA at room temperature and return it to the refrigerator more than once. Clearly record the starting date at room temperature storage in the space provided on the outer carton. At the end of the 3-month period, immediately use, discard, or return the product to refrigerated storage. The diluent syringe may be stored at 2° to 25°C (36° to 77°F). Do not use XYNTHA after the expiration date. Do not freeze. (Freezing may damage the prefilled diluent syringe.) During storage, avoid prolonged exposure of XYNTHA vial to light. Store the reconstituted solution at room temperature prior to administration. Administer XYNTHA within 3 hours after reconstitution.