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

Resources for Your Office

Stay up-to-date with information from Pfizer Hemophilia

CNE nurse educator speaker series

The hemophilia-focused series addresses the challenges of hemophilia and covers a wide range of topics that directly impact patients, caregivers, and health care professionals. Presented by your local Pfizer Nurse Educator or a Pfizer Speakers Bureau representative, the topics covered by the program include:

  • How can you help? Education for caregivers of adults with hemophilia
  • Customized purification processes designed with viral safety in mind
  • Encouraging early independence
  • Healthy lifestyle choice: the role of medication adherence
  • Life stages (multiple presentations)
  • New horizons for older adults
  • Pfizer and you
  • The basics of hemophilia

To learn more about the CNE Nurse Educator Speaker Series
or to arrange for a presentation, contact your Pfizer Hemophilia
representative or e-mail info@hemophilia.com

*BeneFix was approved February 11, 1997.1