The Food and Drug Administration (FDA) has approved new single-dose vial strengths of Nuwiq, a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in adults and children with hemophilia A. Specifically, Nuwiq is approved for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

In addition to the currently available strengths (250, 500, 1000, 2000 IU), starting in September, Nuwiq will also be supplied in 2500, 3000, and 4000 IU vial strengths. “The variety of vial options will be particularly beneficial to patients who previously may have needed more than one of the lower-strength vials, ” said Octapharma USA President Flemming Nielsen.

The new vial options are also beneficial for patients being treated with Nuwiq using pharmacokinetic (PK)-guided personalized dosing. Data from Octapharma’s clinical study (GENA-21) on PK-guided dosing with Nuwiq showed that 83% of hemophilia A patients were spontaneous bleed-free throughout the 6-month study period; 57% were able to reduce infusions to twice-weekly or less.

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Each package of Nuwiq contains a prefilled syringe of solvent, a vial adapter, a butterfly needle, and alcohol. swabs.  

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