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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.

OFFER TERMS: By using the Pfizer Factor Savings Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare or any other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan, available in Puerto Rico, formerly known as “La Reforma de Salud”). The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs. You may receive a total benefit of $12,000 over 12 months, or the amount of your co-pay over 12 months less a patient financial responsibility of $10 per month, whichever is less. You must deduct the value of this offer from any reimbursement requests submitted to your insurance plan either by you or on your behalf. The Card is not valid where otherwise prohibited by law. The Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. The card will be accepted only at participating pharmacies. This coupon is not health insurance. Offer good only in the U.S. and Puerto Rico. The Card is limited to 1 per person during this offering period and is not transferable. Offer limited to one use per month up to 12 times per patient per year. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. Offer expires 12/31/17. No membership fees.