AFSTYLA

Antihemophilic Factor (Recombinant), Single Chain

CSL Behring

AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:

• On-demand treatment and control of bleeding episodes,
• Routine prophylaxis to reduce the frequency of bleeding episodes,
• Perioperative management of bleeding.

Limitation of Use
AFSTYLA is not indicated for the treatment of von Willebrand disease (1).

Store AFSTYLA in the original package to protect the AFSTYLA vials from light. Store AFSTYLA in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the diluent vial. AFSTYLA can be stored at room temperature, not to exceed 25°C (77°F), for a single period of up to 3 months, within the expiration date printed on the carton and vial labels. Record the starting date of room temperature 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 for 3 months, or after the expiration date on the product vial, whichever is earlier. Do not use AFSTYLA after the expiration date indicated on the vial. The reconstituted product (after mixing dry product with diluent) can be stored at 2°C to 8°C (36°F to 46°F), or at room temperature, not to exceed 25°C (77°F), for up to 4 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 4 hours, it must be discarded. Do not use AFSTYLA if the reconstituted solution is cloudy or has particulate matter. Discard any unused AFSTYLA.