BeneFIX is a recombinant human blood coagulation factor IX indicated for adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:

o

On-demand treatment and control of bleeding episodes. (1)

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Perioperative management of bleeding. (1)

o

Routine prophylaxis to reduce the frequency of bleeding episodes. (1)

Limitations of Use

BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B. (1)

For intravenous use after reconstitution only.

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One international unit (IU) of BeneFIX per kilogram of body weight increased the circulating activity of factor IX as follows:

o

Adolescents/Adults (≥12 years): 0.8 ± 0.2 IU/dL (range 0.4 to 1.2 IU/dL). (2.1)

o

Children (<12 years): 0.7 ± 0.3 IU/dL (range 0.2 to 2.1 IU/dL). (2.1)

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Determine the initial estimated dose using the following formula:

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Dosage and duration of treatment with BeneFIX depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX. (2)

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Routine Prophylaxis:
For long-term prophylaxis against bleeding, the recommended regimen is 100 IU/kg once weekly. Adjust the dosing regimen (dose or frequency) based on the patient's clinical response. (2.1)

BeneFIX is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU. (3)

Do not use in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. (4)

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Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment with the product and seek emergency treatment. Patients may develop hypersensitivity to hamster (CHO) protein as BeneFIX contains trace amounts. (5.1)

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BeneFIX has been associated with the development of thromboembolic complications, including in patients receiving continuous infusion through a central venous catheter. (5.2)

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Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX. (5.3)

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Development of neutralizing antibodies (inhibitors) to BeneFIX may occur. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, perform an assay that measures factor IX inhibitor concentration. (5.4)

The most common adverse reactions (incidence >5%) from clinical trials were fever, cough, nausea, injection site reaction, injection site pain, headache, dizziness and rash. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pediatric Use: Lower recovery, shorter half-life and higher clearance (based on kg body weight) have been observed in children (<12 years). Dose adjustment may be needed. (8.4, 12.3)