ESPEROCT

ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] lyophilized powder for solution, for intravenous use.

Novo Nordisk

ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for:

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

Store ESPEROCT in the original package to protect the ESPEROCT vial from light.

Store ESPEROCT in a powder form under refrigeration at 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.

ESPEROCT may be stored at room temperature [not to exceed 86°F(30°C)] for up to 12 months within the 30-month time period. Record the date on the carton when the product was removed from the refrigerator. The total time of storage at room temperature should not exceed 12 months. Do not return the product to the refrigerator after room temperature storage.

Do not use ESPEROCT beyond the expiration date printed on the vial or 12 months after the date it was removed from refrigeration (whichever is earlier).

Do not freeze ESPEROCT.

Use ESPEROCT within 4 hours after reconstitution when stored at room temperature, or within 24 hours when stored in the refrigerator. Store the reconstituted product in the vial.

Reconstituted product must be discarded after 4 hours at room temperature, or 24 hours in the refrigerator.