Nuwiq

Product Specs	Description
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/Shelf Life	Store in the original package to protect from light. Store in powder form at 2 – 8°C (35 – 46°F) for up to 24 months. Do not freeze. During the shelf life, the product may be kept at room temperature [up to 25°C (77°F)] for a single period not exceeding 3 months. After storage at room temperature, do not return the product to the refrigerator. Do not use after the expiration date. Keep the reconstituted solution at room temperature. Do not refrigerate after reconstitution. Use the reconstituted solution immediately or within 3 hours after reconstitution.
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.)