BeneFIX: For once-weekly prophylaxis and on-demand use​​​​​​​2

Dosing Options

BeneFIX provides dosing options to meet the needs of your patients2

FOR ROUTINE PROPHYLAXIS:

  • The recommended regimen is 100 IU/kg once weekly
  • Dosing amount and frequency should be adjusted based on individual needs and clinical response

FOR ON-DEMAND BLEED CONTROL:

  • 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

BeneFIX can be stored at room temperature or refrigerated, from 2°C to 30°C/36°F to 86°F, for up to 2 years until expiration. BeneFIX cannot be frozen.2

Available in a wide range of vial sizes

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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

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

Travel-ready kit with room temperature storage2

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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:
  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.

A BREADTH OF CLINICAL EXPERIENCE—EFFICACY AND SAFETY STUDIED IN MULTIPLE PATIENT TYPES2

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See efficacy data

** This is an optional area where footnotes can live.

  • 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 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.

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.