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About BeneFix

What is BeneFix?

BeneFix is a recombinant clotting factor IX that temporarily
replaces the factor IX that is missing or at low levels in
people with hemophilia B.

Designed with viral safety in mind

  • Not derived from human blood and contains no preservatives or added human or
    animal components
  • Over 150 quality control tests are done on each batch of BeneFix

BeneFix—the recombinant factor IX you've
turned to for more than 20 years

Chinese hamster ovary (CHO) cells used to manufacture BeneFix are grown in media containing
no added human or animal components.

Bleed control and prevention

Demonstrated bleed control and prevention in previously untreated patients

In clinical studies,

BeneFix prevented bleeds:

84.3%of patients

had no spontaneous
bleeds within 48 hours of
receiving an infusion of BeneFix

Includes patients who received routine
infusions to prevent spontaneous bleeding
and intermittent administration prior to
activity or procedure.

BeneFix controlled bleeds:

75%of bleeds

in a clinical trial
were controlled after
1 infusion

  • 14.9% were controlled after 2 infusions
  • 5.4% were controlled after 3 infusions
  • 2.4% were controlled after 4 infusions
  • 2.2% were controlled after >4 infusions


A multicenter, open-label, single-cohort study in which 54 PUPs were administered BeneFix (recombinant factor IX, rFIX) for (1) on-demand treatment in response to any bleeding episode (dose as deemed appropriate by the investigator), (2) routine prophylaxis for prevention of bleeding episodes, or (3) surgical prophylaxis. Patients who completed the core phase of the study 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 by the sponsor. This research was originally published in Blood.

Experience with previously treated patients (PTPs)

In clinical studies,

BeneFix prevented bleeds:

97%of bleeds

In a clinical trial involving 36 surgical procedures,
97% of bleed control ratings were "excellent" or "good"

  • 3% of responses were rated moderate

BeneFix controlled bleeds:

90.9%of responses

The first infusion of BeneFix was rated excellent or good
in 90.9% of responses

  • 7.1% of infusions were rated moderate
  • 0.7% of infusions were rated as no response
  • 1.3% of infusions were not rated


A 20-center international trial was conducted in 56 previously treated patients with severe or moderate (<5 IU/dL factor IX activity) hemophilia B. Participants received recombinant factor IX for pharmacokinetic studies, treatment of or prophylaxis against hemorrhage, or surgical hemostasis (for all interventions the regimen was prescribed by the investigator) for a mean duration of treatment of 23.4 ± 5.3 months and were assessed at 3-month intervals for 2 years. The research was originally published in Blood.


Low levels of inhibitors in BeneFix clinical trials

The body can make antibodies called “inhibitors.” These may stop BeneFix from working properly.
The higher the level of inhibitors, the more they may block effective treatment with BeneFix.

The strength of an inhibitor in a person’s blood is measured in Bethesda units (BU).

  • High titer (more than 5 BU)
  • Low titer (less than 5 BU)

In PUPs in clinical trials:




developed a high-titer

Both patients were
removed from the study.

In PTPs in clinical trials including children and adults:




developed a low-titer

§This patient completed the study and had
normal factor IX recovery (about 15 months
after the inhibitor was detected).

Dosing and R2 kit

Live actively? Talk to your doctor about a BeneFix dosing
regimen that’s right for you

BeneFix offers dosing flexibility with 5 vial sizes

  • 250 IU
  • 500 IU
  • 1000 IU
  • 2000 IU
  • 3000 IU

Flexibility and convenience:

BeneFix Rapid Reconstitution R2 Kit

  • Range of vial sizes
  • Travel-ready pack
  • Single-use vial
  • Sterile infusion set
  • Environmentally friendly
    packaging means less waste

BeneFix can be stored at room temperature or under refrigeration
(2°C to 30°C/36°F to 86°F) for up to 2 years, until expiration.