This site is intended for U.S. healthcare professionals.

Visit Pfizer Medical

Menu

Close

Sign InLog OutTherapy AreasProductsOrder VaccinesOrder SamplesOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysPfizer Dermatology Patient AccessExplore ContentEventsMaterialsVideosContact
Search

Menu

Close

HomeAboutEfficacy & SafetyEfficacy &
SafetyOnce-Weekly ProphylaxisOn-Demand Bleed ControlSurgical EfficacyDosingSupport & ResourcesSupport & ResourcesEventsMaterialsVideosResources for Patients and CaregiversAdditional Resources
Related: See information on our hemophilia A productPrescribing Information Indication
BeneFIX Coagulation Factor IX (Recombinant): For once-weekly prophylaxis and on-demand use2Dosing OptionsBeneFIX: For once-weekly prophylaxis and on-demand use2Dosing Options Available in a wide range of vial sizes

All doses come with the same 5-mL diluent.2

 How to calculate dosing

Dosing and duration should be individually determined for each patient, taking into account age and duration, severity of the factor IX deficiency, location and extent of bleed, clinical conditions, and recovery of factor IX.2

 The BeneFIX Rapid Reconstitution (R2) Kit offers a fast preparation process2

Travel-ready kit with room temperature storage2
  • Gauze pad, bandage, alcohol swabs
  • Needleless rapid reconstitution reduces the risk of punctures
  • 25-gauge Terumo® safety shield needle
  • Clear vial adapter to confirm a good connection    
  • Prefilled diluent syringe means fewer components and fast preparation
Convenient room temperature storage
  • 2ºC to 30ºC/36ºF to 86ºF2
  • Up to 2 years until expiration
  • Do not use BeneFIX after the expiration date on the label2
  • Do not freeze to prevent damage to the diluent syringe2
  • The product does not contain a preservative and should be used within 3 hours of reconstitution2

Terumo is a registered trademark of Terumo Corporation.

References: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. A BREADTH OF CLINICAL EXPERIENCE—EFFICACY AND SAFETY STUDIED IN MULTIPLE PATIENT TYPES2 See efficacy data Loading

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2025 Pfizer Inc. All rights reserved.

PP-BEN-USA-0773
You are now leaving Pfizer You are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer. 

PP-MCL-USA-0367
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.