Human Coagulation Factor VIII (rDNA) (simoctocog alfa)
Human coagulation factor VIII produced in a human cell line by recombinant DNA technology. No animal or human derived materials are added during the manufacturing process or to the final medicinal product.
Nuwiq® is indicated for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) of all age groups.
Supplied as powder and solvent for solution for injection, with all vial strengths in a 2.5 mL infusion volume and supplied with a pre-filled syringe. Available in vials of: 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU.
83% of patients free from spontaneous bleeds;
57% of patients treated twice-weekly or less;
0 inhibitors or severe treatment related adverse events.
17.6% cumulative incidence of high-titre inhibitors;
27.9% cumulative incidence of all inhibitors;
No inhibitors in patients with non-null F8 mutations.
1. Lissitchkov T et al. Haemophilia 2017; 23:697-704.
2. Liesner R et al. Abstract accepted for presentation at ASH 2019, Orlando, US.
3. Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.
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