BeneFIX

Nonacog α (recombinant coagulation factor IX).

BeneFIX is formulated as a sterile, nonpyrogenic, lyophilized powder preparation. Each single-use vial contains nominally 250, 500, or 1000 international units (IU) of Nonacog alfa (INN) (recombinant coagulation factor IX).

BeneFIX is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

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 In addition, the solution should be withdrawn from the vial using the vial adapter.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.

BeneFIX may be contraindicated in patients with a known history of hypersensitivity to any of the constituents of the preparation or in patients with a known history of hypersensitivity to hamster proteins.

Hypersensitivity; Activity-neutralizing antibodies (inhibitors); Thrombosis; Nephrotic syndrome; Cardiovascular events.

BeneFIX (recombinant coagulation factor IX) should be administered to pregnant & lactating women only if clearly indicated.

Very common: Headache, Cough, Vomiting, Pyrexia.
Common: Factor IX Inhibition, Hypersensitivity, Dizziness, Dysgeusia, Phlebitis, Hypotension, Flushing, Nausea, Rash, Urticaria, Chest discomfort, Infusion-site reaction, Infusion-site pain.

No interactions of recombinant coagulation factor IX products with other medicinal products are known. Temporary correction of abnormal partial thromboplastin time (PTT) was observed; no effect on normal PTT was seen.

BeneFIX has a 36-month expiry period when the product is stored at 2-8°C, with a single short-term period permitted at room temperature not exceeding 30°C for up to 6 months within this expiry period.

Haemostatics

B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

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