Nuwiq



Nuwiq

Product Specs Nuwiq
Manufacturer Name Octapharma
Indications NUWIQ – antihemophilic rFVIII. Produced in a human cell line. B-Domain deleted. Without chemical modifications.
Indications for Adults:

Control and Prevention of Bleeding Episodes

 Yes

Perioperative Management

 Yes

Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes

 Yes
Indications for Children:

Control and Prevention of Bleeding Episodes

 Yes

Perioperative Management

 Yes

Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes

 Yes
Contraindications Nutrient in Cell Culture Patients who have manifested lifethreatening hypersensitivity reactions, including anaphylaxis, to the product or its components.
Stabilizer in Final Formulation 18 mg sodium chloride, 5.4 mg sucrose, 5.4 mg L-arginine hydrochloride, 0.3 mg calcium chloride dihydrate, 1.2mg poloxamer 188, and 1.2 mg sodium citrate dihydrate
Viral Safety Process Chromatography, 20 nm nanofiltration; solvent/detergent
Product Half-Life Terminal* Half-life (± SD) in hours
>12yrs: 17.1 ± 11.2
6-12 yrs: 13.1 ± 2.6
2-5 yrs: 11.9 ± 5.4
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) 2.1 ± 0.3
Storage Requirements
  • Refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature up to 25°C or 77°F for a single period not to exceed 3 months.
  • Do not freeze.
    		•
    Shelf Life 24 months from manufactured date
    6 months at room temperature
    Nominal Vial Size & Diluent Volume 250, 500, 1000, 1500, 2000, 2500, 3000, or 4000 IU/2.5 mL for all vial strengths

    *Note: Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. (Toutain PL, et al. J Vet Pharmacoll Ther. 2004.)


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