Formula & Concentration
Coagulation Factor IX (Recombinant)
ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:
- On-demand treatment and control of bleeding episodes,
- Perioperative management of bleeding,
- Routine prophylaxis to reduce the frequency of bleeding episodes.
Limitation of Use:
ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B. (1)
Shelf Life and Storage
Store ALPROLIX in the original package in order to protect it from light. Store ALPROLIX at 2°C to 8°C (36°F to 46°F). Do not freeze. Freezing will damage the pre-filled diluent syringe. ALPROLIX can be stored at room temperature, not to exceed 30°C (86°F), for a single period of up to 6 months within the expiration date printed on the carton and vial label. If stored at room temperature, record the date on the carton when the product was removed from refrigeration. Use the product before the end of this 6- month period or discard it. Do not place the product back into refrigeration after warming to room temperature. The shelf-life then expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier. Do not use product or diluent after the expiration date printed on the carton, vial or syringe. Reconstituted product may be stored at room temperature, not to exceed 30°C (86°F) for no longer than 3 hours. Protect from direct sunlight. Discard any product not used within 3 hours after reconstitution.