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Wyeth
 BeneFIX® Coagulation Factor IX (Recombinant)

Surgical Efficacy

Proven surgical hemostasis in a study of 28 patients undergoing 36 minor and major surgical procedures.8

Response ratings* of BeneFIX in 36 surgical procedures

*Defined by self-assessment or clinical evaluation.

Surgical Procedures
Procedures Number of Major Procedures (%) Number of Minor Procedures (%)
Orthopedic 11 (47.8%) -
General 6 (26.1%) 6 (46.2%)
Dental 6 (26.1%) 7 (53.8%)
Total procedures 23 (63.9%) 13 (36.1%)

Orthopedic procedures included arthroplasty, arthrodesis, arthroscopic synovectomy, decompression, debridement, fusion, removal of bony spicules, contracture repair, and prosthesis placement; general major procedures included inguinal hernia repair, liver transplantation, splenectomy, and skin/muscle debridement. General minor procedures included dental extraction, skin biopsy, toenail removal, and vasectomy.


During the postoperative rFIX treatment, hemostasis was maintained and there were no spontaneous hemorrhages.8

On-demand Efficacy

1,796 hemorrhages controlled in 56 PTPs with BeneFIX.6

Response ratings* of BeneFIX in 1,796 hemorrhages

Adapted from Roth DA, et al. Blood. 2001;98:3600-3606.

  • BeneFIX controlled all bleeds6
  • 91% of responses rated excellent or good
  • 81% of bleeds treated with a single infusion

*Defined by self-assessment or clinical evaluation.

"All bleeding episodes were controlled exclusively with rFIX using standard dosing intervals, with the majority of hemorrhages responding to one rFIX infusion."—Roth et al6




Indication
BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings. BeneFIX is not indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X) nor the treatment of hemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the treatment of bleeding due to low levels of liver-dependent coagulation factors.

Important Safety Information
• As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, or tiredness.
• BeneFIX may be contraindicated in patients with a known history of hypersensitivity to hamster protein.
• Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.

Please see BeneFIX Prescribing Information

The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.


    
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