Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 750 IU, 1000 IU, 2000 IU; per vial; PEGylated lyophilized pwd for IV inj after reconstitution; preservative-free.
Shire US, Inc.
Indications for ADYNOVATE:
In patients with Hemophilia A: for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations Of use:
Not for treating von Willebrand disease.
Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % of Normal) × 0.5 (IU/kg per IU/dL). Infuse over ≤5 minutes (max infusion rate 10mL/min). Bleeding (Minor): obtain 20–40% FVIII increase; give every 12–24hrs until resolved; (Moderate): obtain 30–60% FVIII increase; give every 12–24hrs until resolved; (Major): obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Perioperative (Minor surgery): obtain 60–100% FVIII increase; give 1hr before surgery; repeat after 24hrs if needed until bleeding resolved; (Major surgery): obtain 80–120% FVIII increase (pre- and post-op); give 1hr before surgery; repeat every 8–24hrs (6–24hrs if <12yrs) until adequate wound healing. Routine prophylaxis: ≥12yrs: give 40–50 IU/kg twice weekly; <12yrs: 55 IU/kg twice weekly; max 70 IU/kg. Adjust based on response.
Prior anaphylactic reaction to Advate. Mouse or hamster protein sensitivity.
Monitor for development of Factor VIII inhibitors. Immediately discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.
Headache, nausea, diarrhea, flushing; antibody formation.
Single-dose vial—1 (w. diluent, Baxject II needleless transfer device)