BeneFIX: For once-weekly prophylaxis (patients ≥16 years old) and on-demand use​​​​​​​2

Additional Resources

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World Federation of Hemophilia (WFH)

A not-for-profit organization dedicated to improving the lives of those with hemophilia and bleeding disorders worldwide.

Visit www.wfh.org

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The National Hemophilia Foundation (NHF)

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.

Visit www.hemophilia.org

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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.

Visit www.isth.org

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Hemostasis & Thrombosis Research Society (HTRS)

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.

Visit www.htrs.org

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North American Camping Conference for 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.

Visit www.arizonahemophilia.org/naccho

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References:
  1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. February 11, 1997. Accessed May 12, 2021. wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm
  2. BeneFIX. Prescribing information. Pfizer Inc.; 2021.

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  • BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein (CHO).
  • 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 protein as BeneFIX contains trace amounts.
  • BeneFIX has been associated with the development of thromboembolic complications, including in 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 fever, cough, nausea, injection site reaction, injection site pain, headache, dizziness, and rash.

BeneFIX, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated for the treatment of:

  • Adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
    • On-demand treatment and control of bleeding episodes.
    • Perioperative management of bleeding.
  • Patients 16 years of age and older with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
    • Routine prophylaxis to reduce the frequency of bleeding episodes.

Limitation of use:

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

Please see full Prescribing Information for BeneFIX.

Indication

BeneFIX, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated for the treatment of:

  • Adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
    • On-demand treatment and control of bleeding episodes.
    • Perioperative management of bleeding.
  • Patients 16 years of age and older with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
    • Routine prophylaxis to reduce the frequency of bleeding episodes.

Limitation of use:
BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B.

Please see full Prescribing Information for BeneFIX.