Formula & Concentration

Antihemophilic Factor (Recombinant), PEGylated

Manufacturer

Takeda

Indications

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)

Product Options

Package Size

NDC #

Presentation

401 IU – 800 IU

00944-4623-01

Vial

750 IU

00944-4626-01

Vial

801 IU – 1250 IU

00944-4624-01

Vial

1801 IU – 2500 IU

00944-4625-01

Vial

1500 IU

00944-4627-01

Vial

3000 IU

00944-4628-01

Vial

Shelf Life and Storage

Store ADYNOVATE in powder form at 2°C to 8°C (36°Fto46°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.