ELOCTATE

[Antihemophilic factor (recombinant), Fc fusion protein]

Sanofi Genzyme

ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) 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
ELOCTATE is not indicated for the treatment of von Willebrand disease. (1)

30 Months

Prior to reconstitution: Store ELOCTATE in the original package to protect the ELOCTATE vials from light. Store ELOCTATE in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the pre-filled diluent syringe. ELOCTATE may 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 label. If stored at room temperature, record the date that ELOCTATE is removed from refrigeration on the carton in the area provided. After storage at room temperature, do not return the product to the refrigerator. Do not use beyond the expiration date printed on the vial or 6 months after the date that was written on the carton, whichever is earlier. After Reconstitution: The reconstituted product may be stored at room temperature, not to exceed 30°C (86°F), for up to 3 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 3 hours, it must be discarded. Do not use ELOCTATE if the reconstituted solution is cloudy or has particulate matter. Discard any unused ELOCTATE.