Indications for NOVOEIGHT:
In patients with Hemophilia A: for on-demand treatment and control 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 (esp. in previously untreated patients [PUPs]). Discontinue immediately if hypersensitivity reactions occur. Obesity (BMI ≥30kg/m2). Pregnancy. Nursing mothers.
Inj site reactions, pyrexia; anaphylaxis, inhibitors in PUPs.
Generic Drug Availability:
Single-dose vial—1 (w. diluent, supplies)