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

Surgical Efficacy

Management of hemostasis in surgical procedures

In a subset analysis, 95.5% of responses were rated excellent or good in both PTPs and PUPs receiving BeneFIX and undergoing surgery2

  • 1.5% were rated moderate, 3.0% of responses were not provided2

28 PTPs underwent 36 surgeries2,†

  • 23 (63.9%) were major surgeries3
  • 13 (36.1%) were minor surgeries, including 7 minor dental procedures3

23 PUPs underwent 30 surgeries2,‡

  • 28 were minor surgeries2
  • 2 were hernia repairs2

Dental and minor procedures2

  • 92% of responses rated excellent or good in PTPs during dental procedures2
  • 96% of responses rated excellent or good in PUPs during minor procedures2

Surgical management rating scale: Efficacy was graded by subjective assessment of response to surgery by the subject and by the physician, in consultation with the surgeon. The response was rated excellent if the response was as satisfactory, with as much and as rapid an improvement as the best responses with other rFIX products for similar bleeds or procedures; good if the response was as satisfactory, with as much and as rapid an improvement as most responses with other rFIX products for similar bleeds or procedures; moderate if the response was less than satisfactory and not as good as most responses seen with other rFIX products when used for similar bleeding episodes or similar procedures; or no response if no improvement at all was observed.4,5

Study description (PTPs)

A 20-center international trial was conducted in PTPs with severe or moderate (<5 IU/dL FIX activity) hemophilia B. Participants received rFIX for pharmacokinetic studies, treatment of or prophylaxis against hemorrhage, or surgical hemostasis, and were assessed at 3-month intervals for 2 years.5

Study description (PUPs)

A multicenter, international, open-label, single-cohort study consisting of a core phase and an extension phase. In the core phase, patients received rFIX for (1) on-demand treatment in response to any bleeding episode, (2) routine prophylaxis, or (3) surgical prophylaxis. Patients who completed the core phase were allowed to enter the extension phase to receive rFIX for up to 1 additional year, at the discretion of the investigator and after prior written authorization from the sponsor.2,4

   In the PTP surgery subjects, the median increase in circulating FIX activity was 0.7 IU/dL per IU/kg infused (range 0.3-1.2 IU/dL; mean 0.8 ± 0.2 IU/dL per IU/kg).2

   In the PUP surgery subjects, the mean dose per infusion was 89.87 ± 51.95 IU/kg, and mean duration of treatment was 5.09 ± 3.96 days.4

BeneFIX is available in hundreds of institutions nationwide.6


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. Ragni MV, Pasi KJ, White GC, Giangrande PL, Courter SG, Tubridy KL; Recombinant FIX Surgical Study Group. Use of recombinant factor IX in subjects with haemophilia B undergoing surgery. Haemophilia. 2002;8(2):91-97. doi:10.1046/j.1365-2516.2002.00587.x
  4. Shapiro AD, Di Paola J, Cohen A, et al; Recombinant Factor IX Study Group. The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B. Blood. 2005;105(2):518-525. doi:10.1182/blood-2004-06-2283
  5. Roth DA, Kessler CM, Pasi KJ, Rup B, Courter SG, Tubridy KL; Recombinant Factor IX Study Group. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood. 2001;98(13):3600-3606. doi:10.1182/blood.v98.13.3600
  6. Data on file. Pfizer Inc., New York, NY.

Efficacy & Safety

  • Once-Weekly Prophylaxis
  • On-Demand Bleed Control
  • Surgical Efficacy
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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.