ADYNOVATE- antihemophilic factor (recombinant) pegylated

Baxalta US, Inc.

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

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

ADYNOVATE is not indicated for the treatment of von Willebrand disease. (1)

Store ADYNOVATE in powder form at 2°C to 8°C (36°F to 46°F).

Do not freeze.

ADYNOVATE may be stored at room temperature not to exceed 30°C (86°F) for a period of up to 3 months not to exceed the expiration date. If stored at room temperature, write the date on the carton when ADYNOVATE is removed from refrigeration.

After storage at room temperature, do not return the product to the refrigerator.

Do not use beyond expiration date printed on the carton or housing.

Store ADYNOVATE in the original box and protect from extreme exposure to light.