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Nuwiq - 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.
Indication
Nuwiq® is indicated for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) of all age groups.
Presentation
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.
Convenient twice-weekly dosing to effectively prevent bleeds in patients on personalised prophylaxis1:
- 83% of patients free from spontaneous bleeds;
- 57% of patients treated twice-weekly or less;
- 0 inhibitors or severe treatment related adverse events.
In 66 adult patients with haemophilia A on personalised prophylaxis with Nuwiq®1 Favourable rate of inhibitors in previously untreated patients (PUPs) demonstrated in NuProtect, the largest prospective study in true PUPs with a single FVIII product2:
- 17.6% cumulative incidence of high-titre inhibitors;
- 27.9% cumulative incidence of all inhibitors;
- No inhibitors in patients with non-null F8 mutations.
In 105 PUPs in the NuProtect Study2. Zero inhibitors in over 190 previously treated patients switching to Nuwiq® in clinical trials3