BETHESDA, MD 31 Mar 2014—FDA and Biogen Idec on March 28 announced the approval of recombinant factor IX Fc fusion protein, or Alprolix, for use in patients with hemophilia B.
The prolonged circulating half-life of the fusion protein allows patients with hemophilia B to go at least one week between routine prophylactic injections, according to the new product's labeling (PDF).
Recombinant factor IX Fc fusion protein, its labeling states, is for use in patients with hemophilia B to manage them during the perioperative period, control and prevent bleeding episodes, and routinely prevent bleeding episodes or reduce their frequency.
For the routine prophylaxis of bleeding episodes, the labeling recommends a dosage of 50 IU/kg once weekly or 100 IU/kg once every 10 days.
The recommended dosage for the biological's other uses depends on the patient's circulating level of coagulation factor IX and the severity of the bleeding episode.
All doses are to be administered by i.v. bolus infusion no later than three hours after reconstitution of the biological and at a rate not exceeding 10 mL/min.
During the clinical studies of the biological, headache and oral paresthesia were the most commonly reported adverse reactions.
Alprolix will be available in single-use vials containing approximately 500, 1000, 2000, or 3000 IU of coagulation factor IX as a lyophilized powder. Each vial will be part of a kit that also contains a syringe prefilled with 5 mL of diluent and sealed with a plunger stopper and cap and a sterile vial adapter for reconstituting the powder.
Vials of the biological should be stored at 2–8 °C. They may be stored at room temperatures not exceeding 30 °C for one six-month period.
Biogen Idec said it plans to make its new product available in early May.