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HomeAboutEfficacy & SafetyEfficacy &
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Related: See information on our hemophilia A productPrescribing Information Indication
Experience MattersBeneFIX Coagulation Factor IX (Recombinant): For once-weekly prophylaxis and on-demand use2BeneFIX: Once-weekly prophylactic and on-demand dosing to fit patients’ lifestyles—from the only recombinant factor IX (FIX) supporting individuals with hemophilia B for more than 20 years.1,2,*
See once-weekly prophylaxis data
Loading Proven bleed control

A breadth of clinical experience—efficacy and safety studied in previously untreated patients (PUPs) and in previously treated patients (PTPs).2

See on-demand data
Loading Dosing options to meet patients’ needs

Routine prophylaxis recommended regimen is 100 IU/kg once weekly, and a wide range of vial sizes is available for on-demand bleed control.2

Learn more about dosing options
Loading Experience matters

Learn about the clinical history and manufacturing and purification process of BeneFIX.

 Read more Loading Access Available in hundreds of institutions nationwide399% of commercially insured patients have access to BeneFIX3
See resources and support options
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Pfizer has a number of financial support resources and programs for your eligible patients.

 Learn more  Loading Stay connected with BeneFIX and Pfizer

Sign up to receive important information about BeneFIX, hemophilia B, and more.

 Register now LoadingReferences: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 October 7, 2022. wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htmBeneFIX. Prescribing information. Pfizer Inc.; 2021.Data on file. Pfizer Inc., New York, NY.

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Indication BeneFIX, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for the on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and 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.
Important Safety Information
  • 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.
Indication BeneFIX, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for the on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and 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.