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Bleeding disorders
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Drug Name:


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.


Therapeutic Use:

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.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Paresthesia, headache, inj site inflammation/pain, non-neutralizing anti-FVIII antibody formation, back pain, vertigo, dry mouth.

Generic Availability:


How Supplied:

Single-dose vial—1 (w. diluent, supplies)

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