Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Indications for NOVOEIGHT:
In patients with Hemophilia A: for control and prevention of bleeding, for perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.
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). Inject slowly over 2–5 mins. Bleeding: Minor: obtain 20–40% FVIII increase; give every 12–24hrs for ≥1 day until resolved. Moderate: obtain 30–60% FVIII increase; give every 12–24hrs for 3–4 days until resolved. Major: obtain 60–100% FVIII increase; give every 8–24hrs for 7–10 days until resolved. Perioperative: Minor: obtain 30–60% FVIII increase; give every 24hrs for ≥1 day until healed. Major (pre- and post-op): obtain 80–100% FVIII increase every 8–24hrs until adequate wound healing, then continue for ≥7 days to maintain FVIII activity of 30–60%. Routine prophylaxis: <12yrs: give 25–60 IU/kg 3 times weekly or 25–50 IU/kg every other day; ≥12yrs: give 20–50 IU/kg 3 times weekly or 20–40 IU/kg every other day. Adjust based on response.
Hamster protein sensitivity.
Not for von Willebrand's disease. Monitor for development of Factor VIII inhibitors. Immediately discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.
Inj site reactions, increased hepatic enzymes, pyrexia; anaphylaxis, antibody formation.
Single-dose vial—1 (w. diluent, supplies)
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