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BeneFIX Works

BeneFIX Works

BeneFIX has been proven effective in several important 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

An important clinical study showed that BeneFIX prevented bleeds in many
 previously untreated patients (PUPs):

  • 27 of 32 PUPs experienced no spontaneous bleeding (bleeding not caused by injury) within 48 hours of infusion with BeneFIX
  • 84.3% of PUPs experienced no spontaneous bleeds and 15.6% of PUPs experienced spontaneous bleeds
  • BeneFIX received a 97.7% excellent or effective response rating by patients in the study
  • 91.3% of patients rated their infusion response as excellent; 6.4% rated it as effective; 1.7% rated it as inadequate; and 0.6% didn’t rate it
  • Study design: 24 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

A separate study also examined how BeneFIX controlled spontaneous bleeding or bleeding caused by injury in previously treated patients (PTPs):

  • Among 55 PTPs with bleeding episodes, all 1,796 bleeds were controlled
  • — 90.9% of responses to first infusion for bleeding episodes were rated excellent or good
  • — 7.1% were rated moderate
  • — 0.7% were rated no response
  • — 1.3% were not rated
  • 1 infusion of BeneFIX was needed to control most (81%) bleeds
  • Study design: 56 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.