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BeneFIX Works: 12+ years of Clinical Experience

Plan ahead―it may help you prevent a bleed

  • Consider infusing before any activity that may risk causing a bleed
  • Preventive infusions may help you get on with your busy life

Make a plan―it may help you participate in more activities

  • Contact your health care provider to discuss whether preventive treatment may be right for you
  • Together, you and your health care provider can come up with a treatment plan to help you with your goals
Check out activity risk ratings

BeneFIX Works

BeneFIX has been proven effective in several clinical trials. In some studies, BeneFIX was tested for its ability to prevent bleeds, and in others, for its ability to control bleeds once they started. The results add up to treatment that may work for you. Talk to your doctor about which factor IX product may be right for you.

BeneFIX prevented bleeds

In a clinical trial, 27 of 32 previously untreated patients (PUPs) did not experience spontaneous bleeds (bleeding not caused by injury) within 48 hours of preventive infusions.

Majority of PUPs on a preventive regimen did not have bleeds

BeneFIX prevented bleeds: Majority of previously untreated patients on a preventative regimen did not have bleeds
  • 97.7% excellent or effective response rating by patients in the study
  • Patients rated infusion outcomes as excellent (91.3%), effective (6.4%), or inadequate (1.7%); not rated (0.6%)

Study design: Twenty-four PUPs were administered BeneFIX at least twice weekly. Eight PUPs were administered BeneFIX once weekly. The mean dose per infusion was 73.3 ± 33.1 IU/kg, and the mean duration of treatment was 14.4 ± 8.1 months.

BeneFIX controlled bleeds

In a separate study of 55 previously treated patients (PTPs) with bleeding episodes, all 1,796 bleeds were controlled.

9 out of 10 responses to first infusion for bleeding episodes in PTPs were rated excellent or good*

BeneFIX controlled bleeds: Study of 55 previously treated patients with bleeding episodes, all bleeds were controlled

*Responses were defined by self-assessment or clinical evaluation.

  • 81% of bleeds in PTPs resolved with 1 infusion of BeneFIX
  • Median infusion dose was 42.8 IU/kg

Study design: Fifty-six PTPs were treated for bleeding episodes. The mean duration of treatment was 23.4 ± 5.3 months. The regimen was prescribed by the investigator.

BeneFIX is also approved for the control and prevention of bleeding in patients undergoing surgery

  • Talk to your doctor if you plan to have surgery
 

What Is BeneFIX?

BeneFIX is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease.

BeneFIX is NOT used to treat hemophilia A.

Important Safety Information for BeneFIX

  • BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
  • Call your health care provider right away if your bleeding is not controlled after using BeneFIX.
  • Allergic reactions may occur with BeneFIX. Call your health care provider or get emergency treatment right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, your lips and gums turning blue, fast heartbeat, facial swelling, faintness, rash or hives.
  • Your body can make antibodies, called “inhibitors,” which may interfere with the effectiveness of BeneFIX.
  • If you have risk factors for developing blood clots, such as a venous catheter through which BeneFIX is given by continuous infusion, BeneFIX may increase the risk of abnormal blood clots. The safety and efficacy of BeneFIX administration by continuous infusion have not been established.
  • Some common side effects of BeneFIX are nausea, injection site reaction, injection site pain, headache, dizziness and rash.