Data from FDA (Food and Drug Administration, USA) - Curated by Toby Galbraith - Last updated 09 June 2017

Indication(s)

NUWIQis 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. (1)

Full Prescribing information

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Advisory information

contraindications

NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components (4)

Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue NUWIQ and administer appropriate treatment. (5.1)
• Development of Factor VIII neutralizing antibodies (inhibitors) may occur. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. (5.2)
• Monitor all patients for Factor VIII activity and development of Factor VIII inhibitor antibodies. (5.3)

Adverse reactions

The most frequently occurring adverse reactions (>0.5%) in clinical trials were paresthesia, headache, injection site inflammation, injection site pain, non-neutralizing anti-Factor VIII antibody formation, back pain, vertigo, and dry mouth. (6)

Usage information

Dosing and administration
For intravenous use after reconstitution
• Each vial of NUWIQ is labeled with the actual amount of Factor VIII potency in international units (IU).
• Determine dose using the following formula for adolescents and adults:
Required IU = body weight (kg) x desired Factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)

• Dosing for routine prophylaxis:
Subjects Dose (IU/kg) Frequency of infusions
Adolescents [12 - 17 yrs]
and adults
30 - 40 Every other day
Children [2 - 11 yrs] 30 - 50 Every other day or
three times per week

• Frequency and duration of therapy depends on severity of the FVIII deficiency, location and extent of bleeding, and patient’s clinical condition.

Use in special populations
Pediatric Use: Lower recovery, shorter half life and faster clearance in children aged 2 - ≤12 years. Higher doses and/or a more frequent dosing schedule for prophylactic treatment should be considered in pediatric patients aged 2 to 5 years. (8.4).

More information

Category Value
Authorisation number BLA125555
Orphan designation No
Product NDC 68982-139; 68982-141; 68982-143; 68982-145
Date First Approved 01-01-2016
Marketing authorisation holder Octapharma USA, Inc.