Formula & Concentration
(Antihemophilic – Factor [Recombinant])
Novoeight® is an Antihemophilic Factor (Recombinant) indicated for use in adults and children with hemophilia A for:
- Control and prevention of bleeding
- Perioperative management
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Novoeight® is not indicated for the treatment of von Willebrand disease. (1)
Shelf Life and Storage
Refrigerated up to thirty (30) months. Room temperature up to twelve (12) months
Store Novoeight® in the original package in order to protect from light. Store Novoeight® under refrigeration at a temperature of 36°F to 46°F (2°C to 8°C) for up to 30 months from the date of manufacture until the expiration date stated on the label. Within the 30-month period, Novoeight® may also be stored at room temperature not to exceed 86°F (30°C) for up to twelve (12) months. If you choose to store Novoeight® at room temperature, clearly record the date when the product was removed from the refrigerator in the space provided on the outer carton. The total time of storage at room temperature should not exceed 12 months. Do not return the product to the refrigerator. Do not use Novoeight® after the end of the 12-month period at room temperature storage, or after the expiration date stated on the vial, whichever occurs earlier. Do not freeze Novoeight®.