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

Commitment to the Community

Pfizer's commitment to the hemophilia community extends beyond just providing factor—it's about community support and resources too

Scholarship Program

Pfizer awards up to $50,000 in scholarships to students in the hemophilia community.

www.hemophiliavillage.com/hemophilia-scholarship-program

Scholarship Program

Steps for Living

A one-stop resource of information for your patients with bleeding disorders—for kids, adolescents, parents, and health educators to promote healthy living for the whole family.

www.stepsforliving.hemophilia.org/

Steps for Living

Additional Resources

World Federation of Hemophilia (WFH)
A not-for-profit organization dedicated to improving the lives of those with hemophilia and bleeding disorders worldwide.

www.wfh.org

World Federation of Hemophilia

National Hemophilia Foundation (NHF)
The NHF is dedicated to finding better treatments and cures for bleeding disorders and to preventing the complications of these disorders through education, advocacy, and research.

www.hemophilia.org

National Hemophilia Foundation

The International Society on Thrombosis and Haemostasis (ISTH)
ISTH is a global not-for-profit organization advancing the understanding, prevention, diagnosis, and treatment of thrombotic and bleeding disorders.

www.isth.org

Hemostasis & Thrombosis Research Society
HTRS is a North American professional medical society dedicated to advancing care for people with bleeding and thrombotic disorders through investigator-initiated research, mentoring, and continuing medical education.

www.htrs.org

European Association for Haemophilia and Allied Disorders (EAHAD)
A multidisciplinary association of HCPs who care for individuals with hemophilia and other bleeding disorders. The EAHAD promotes clinical care, education, and research for patients with bleeding disorders.

www.eahad.org

European Association for Hemophilia

North American Camping Conference of Hemophilia Organizations (NACCHO)
The only global conference dedicated to sharing best practices for summer camps for children in the bleeding disorders community. The Arizona Hemophilia Association conducts NACCHO yearly.

www.naccho.com

North American Camping Conference

*BeneFix was approved February 11, 1997.1