Nuwiq

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Nuwiq Generic Name & Formulations

General Description

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.

Pharmacological Class

Clotting factor.

How Supplied

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

Manufacturer

Generic Availability

NO

Nuwiq Indications

Indications

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.

Nuwiq Dosage and Administration

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.

Nuwiq Contraindications

Not Applicable

Nuwiq Boxed Warnings

Not Applicable

Nuwiq Warnings/Precautions

Warnings/Precautions

Not for von Willebrand's disease. Monitor for development of Factor VIII inhibitors. Immediately discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.

Nuwiq Pharmacokinetics

See Literature

Nuwiq Interactions

Not Applicable

Nuwiq Adverse Reactions

Adverse Reactions

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

Nuwiq Clinical Trials

See Literature

Nuwiq Note

Not Applicable

Nuwiq Patient Counseling

See Literature

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