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Nuwiq
  • Professionals
  • FDA PI

Nuwiq

Generic name:antihemophilic factor (recombinant)
Dosage form: injection
Drug class:Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Jun 1, 2021.


Indications and Usage for Nuwiq

Nuwiq is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in adults and children with Hemophilia A for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Nuwiq is not indicated for the treatment of von Willebrand disease.

Nuwiq Dosage and Administration

For intravenous use after reconstitution

Dose

  • Each vial of Nuwiq is labeled with the actual Factor VIII potency expressed in international units (IU). One IU of Factor VIII activity is defined by the quantity of Factor VIII in one mL of normal human pooled plasma. Calculation of the required dose of Factor VIII is based on the empirical finding that 1 IU Factor VIII per kg body weight raises the plasma Factor VIII activity by approximately 2% of normal activity or 2 IU/dL when assessed using the one stage clotting assay. Use the following formulae to determine the required dose:


  • Dose and duration of therapy depend on the severity of the Factor VIII deficiency, the location and extent of the bleeding, FVIII level, and the patient’s clinical condition.

On-demand Treatment and Control of Bleeding Episodes

A guide for dosing Nuwiq for the on-demand treatment and control of bleeding episodes is provided in Table 1 . Selected dosing regimen should maintain plasma Factor VIII activity levels at or above the plasma levels (in % of normal or in IU/dL) outlined in the table.


Table 1: Dosing for Treatment and Control of...