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.

Reference

  • 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. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/
    ucm057039.htm. Published February 11, 1997. Accessed November 14, 2016.

Reference

  • 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. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/
    ucm057039.htm. Published February 11, 1997. Accessed November 14, 2016.

Reference

  • 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. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/
    ucm057039.htm. Published February 11, 1997. Accessed November 14, 2016.

Reference

  • 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. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/
    ucm057039.htm. Published February 11, 1997. Accessed November 14, 2016.

Rapid Reconstitution (R2) Kit

The BeneFix R2 Kit offers a fast preparation process2

  • Travel-ready kit with room temperature storage2
Reconstitution Kit
  • Gauze pad, bandage, alcohol swab
  • Needleless rapid reconstitution reduces the risk of punctures
  • 25-guage 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

  • 2°C to 30°C/36°F to 86°F2
  • 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 Medical Corporation.