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

Experience

Committed to the hemophilia B community for more than 20 years1,*

  • Over 20 studies, including more than 1500 patients3
  • More than 10 billion IU manufactured4
  • Available in hundreds of institutions nationwide4
  • 99% of commercially insured patients have access to BeneFIX4

Our clinical history1,2,4

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rFIX, recombinant factor IX.

Complex protein production

Established cell line shown to be free of foreign agents and capable of producing large amounts of rFIX in an albumin-free medium5,6,†

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Advanced purification

Customized purification processes designed with viral safety in mind5,6

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Quality validation

Over 150 quality control examinations are performed on each batch of BeneFIX to help ensure a consistent purification process7

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   †Chinese hamster ovary (CHO) cells used to manufacture BeneFIX are grown in media containing no added human or animal components.2


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.
  3. US National Institutes of Health. ClinicalTrials.gov. Accessed September 25, 2020. https://www.clinicaltrials.gov
  4. Data on file. Pfizer Inc., New York, NY.
  5. Adamson S, Charlebois T, O'Connell B, Foster W. Viral safety of recombinant factor IX. Semin Hematol. 1998;35(2 suppl 2):22-27.
  6. Harrison S, Adamson S, Bonam D, et al. The manufacturing process for recombinant factor IX. Semin Hematol. 1998;35(2 suppl 2):4-10.
  7. Edwards J, Kirby N. Recombinant coagulation factor IX (BeneFIX). In: Walsh G, Murphy B, eds. Biopharmaceuticals, an Industrial Perspective. Kluwer Academic Publishers; 1999:73-108.

Dosing options to meet patients' needs

Learn how you can personalize your patients’ dosing.

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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.