General Information

Rixubis (Coagulation Factor IX (Recombinant)] is a recombinant factor IX (rFIX) protein.

Rixubis is specifically indicated for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis to prevent or prevent or reduce the frequency of bleeding episodes in adults with hemophilia B.

Rixubis is supplied as a powder for reconstitution into a solution for intravenous infusion. The initial recommended dose is based on the following formula: Initial Dose = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg). The dose for previously treated patients is 40 to 60 international units per kg twice weekly. Titration of dose may be necessary depending upon the individual patient’s age, bleeding pattern, and physical activity.

Clinical Results

FDA Approval
The FDA approval of Rixubis was based on a phase I/III prospective, open-label, uncontrolled, multicenter study that investigated the pharmacokinetics, efficacy and safety of Rixubis in 73 previously-treated patients (between 12 and 65 years of age) with severe (factor IX level <1 percent) or moderately severe (factor IX level =2 percent) hemophilia B. Subjects received Rixubis either for prophylaxis and/or for the treatment of bleeding episodes on an on-demand basis, and were exposed to a factor IX-containing product on >50 days. Fifty-nine subjects received Rixubis for prophylaxis twice-weekly, and 56 of them received treatment for a minimum of three months. An additional 14 psubjects received Rixubis for the treatment of bleeding episodes only, and had to have at least 12 documented bleeding episodes requiring treatment within 12 months prior to enrollment. Twice-weekly prophylactic treatment with Rixubis for six months achieved a median annualized bleed rate (ABR) of 2.0 with 43% of subjects experiencing no bleeds. In this study, no subjectss developed an inhibitory antibody to FIX and no cases of anaphylaxis were reported.