The FDA has approved Alprolix (coagulation Factor IX [recombinant], Fc fusion protein; Biogen Idec) injection to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and to prevent or reduce the frequency of bleeding episodes in patients with Hemophilia B.

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Alprolix is a fully recombinant, fusion protein that temporarily replaces the missing coagulation Factor IX needed for effective hemostasis. It contains the Fc region of human IgG1, which binds to the neonatal Fc receptor, a part of a naturally occurring pathway that delays lysosomal degradation of immunoglobulins by cycling them back into circulation. This prolonged half-life of the drug allows for less frequent injections in patients.

The safety and efficacy of Alprolix were evaluated in a multi-center clinical trial that compared each of 2 prophylactic treatment regimens to on-demand treatment. Patients with severe Hemophilia B (n=123), ages 12–71, were followed for up to a year and a half. Alprolix demonstrated efficacy in the prevention and treatment of bleeding episodes and during perioperative management of patients undergoing a surgical procedure.

Alprolix will be available in 500 IU, 1000 IU, 2000 IU, and 3000 IU kits containing a single-use vial, a prefilled syringe with diluent, and a sterile vial adapter.

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