ADYNOVATE
ADYNOVATE- antihemophilic factor (recombinant) pegylated
Baxalta US Inc.
1 INDICATIONS AND USAGE
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:
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- On-demand treatment and control of bleeding episodes
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- Perioperative management
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- Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of UseADYNOVATE is not indicated for the treatment of von Willebrand disease.
3 DOSAGE FORMS AND STRENGTHS
ADYNOVATE is a lyophilized powder in single-use vials containing nominally (approximately) 250, 500, 750, 1000, 1500, 2000, and 3000 International Units (IU, units). The 250-1500 IU strengths come with 2 mL Sterile Water for Injection (sWFI); the 2000 and 3000 IU strengths come with 5 mL of sWFI. The actual factor VIII potency/content is labeled on each ADYNOVATE vial.
The potency assignment employs a factor VIII concentrate standard that is referenced to a WHO (World Health Organization) international standard for factor VIII concentrates and is evaluated by appropriate methodology to ensure accuracy of the results.
4 CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).