BeneFIX Dosage/Direction for Use

Treatment with BeneFIX should be initiated under the supervision of a physician experienced in the treatment of hemophilia B. Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Dosing of BeneFIX may differ from that of plasma-derived factor IX products. Patients ≥ 15 years: on average, one IU of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.8 ± 0.2 (range 0.4 to 1.4) IU/dL. Patients < 15 years: on average, one IU of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.7 ± 0.3 (range 0.2 to 2.1 IU/dL; median of 0.6 IU/dL per IU/kg). Dosing for bleeding and surgery: Minor: 20-30 IU/dL, repeat infusion every 12-24 hours for 1-2 days; Moderate: 25-50 IU/dL, repeat infusion every 12-24 hours until bleeding stops and healing begins, about 2-7 days; Major: 50-100 IU/dL, repeat infusion every 12-24 hours for 7-10 days. Dosage for prophylaxis: In a clinical study for routine secondary prophylaxis the average dose for previously treated adult patients (PTP) was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 or 4 days. In younger patients, shorter dosage intervals or higher doses may be necessary. Elderly population: Dose selection for an elderly patient should be individualized.
Administration: BeneFIX is administered intravenously after reconstitution of the lyophilized powder for solution for injection with the supplied diluent. BeneFIX should be administered using the infusion set provided in the kit, and the pre-filled diluent syringe provided or a single, sterile, disposable plastic syringe. In addition, the solution should be withdrawn from the vial using the vial adapter. The reconstituted solution may be stored at room temperature prior to administration. BeneFIX should be administered within 3 hours after reconstitution.