Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU, 4000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Indications for NUWIQ:
In patients with Hemophilia A: for on-demand treatment and control of bleeding episodes, 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). Give by IV bolus infusion at max rate 4mL/min. Bleeding: Minor: obtain 20–40% FVIII increase; give every 12–24hrs for ≥1 day until resolved. Moderate to Major: obtain 30–60% FVIII increase; give every 12–24hrs for 3–4 days or more until resolved. Life-threatening: obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Perioperative: Minor (pre- and post-op): obtain 30–60% FVIII increase; give every 24hrs for ≥1 day until healed. Major (pre- and post-op): obtain 80–100% FVIII increase; give every 8–24hrs until adequate wound healing, then continue for ≥7 days to maintain FVIII activity of 30–60%. Routine prophylaxis: 2–11yrs: give 30–50 IU/kg every other day or 3 times weekly; ≥12yrs: give 30–40 IU/kg every other day. Adjust based on response.
Not for von Willebrand's disease. Monitor for development of Factor VIII inhibitors. Immediately discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.
Paresthesia, headache, inj site inflammation/pain, non-neutralizing anti-FVIII antibody formation, back pain, vertigo, dry mouth.
Single-dose vial—1 (w. diluent, supplies)