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