Important Safety Information and Indication
  • BeneFix, Coagulation Factor IX (Recombinant), is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
  • Hypersensitivity reactions, including anaphylaxis, have been reported with BeneFix. Closely monitor patients for signs and symptoms of acute anaphylaxis, particularly during the early phases of initial exposure to the product. Immediately discontinue the administration of the product and initiate appropriate treatment if symptoms occur.
  • Patients may develop hypersensitivity to hamster (CHO) protein as BeneFix contains trace amounts.
  • BeneFix has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFix administration by continuous infusion have not been established.
  • Neutralizing antibodies (inhibitors) have been reported following the administration of BeneFix. If expected plasma factor IX activity levels are not attained, or if the patient presents with an allergic reaction, or if bleeding is not controlled following an expected dose of BeneFix, perform an assay that measures factor IX inhibitor concentration.
  • The most common adverse reactions (>5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash.

Indication

BeneFix, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease) for the control and prevention of bleeding episodes and peri-operative management.

Limitations of use:

BeneFix is NOT indicated for:

  • treatment of other factor deficiencies (eg, factors II, VII, VIII and X),
  • treatment of hemophilia A patients with inhibitors to factor VIII,
  • reversal of coumarin-induced anticoagulation,
  • treatment of bleeding due to low levels of liver-dependent coagulation factors.

Please see Full Prescribing Information for BeneFix

Flexible Dosing Options

BeneFix offers flexible, personalized dosing to fit your patients' busy lifestyles

  • Approved for use in pediatric and adult patients3
  • Offered in a wide range of vial sizes to meet individual needs3
  • Approved for preventive or on-demand treatment3
  • Formulated for room temperature storage with no refrigeration required3†

Room temperature storage: 2°C to 30°C/36°F to 86°F3

Available in a wide range of vial sizes

  • May reduce the number of vials needed per infusion
  • May save space at home or on the go
  • May have less waste for disposal
  • All doses come with the same 5-mL diluent to simplify the reconstitution experience

How to calculate dosing

Dosing should be individually determined for each patient, taking into account age, weight, severity of factor IX deficiency, location and extent of bleed, clinical condition, and recovery of factor IX.3

*BeneFix was approved February 11, 1997.1