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Click here for BeneFIX® (nonacog alfa) Prescribing Information.  Adverse event reporting information can be found at the bottom of the page.

Reliable efficacy when you and your patients need it most1–3

​​​​​​​Prophylaxis

Prophylactic treatment in PTPs

of responses were rated as excellent or effective (n=47)1,* 

Prophylactic treatment in PUPs

of responses were rated as excellent (n=42), indicating that spontaneous musculoskeletal bleeding was prevented2 

Paediatric patients

of patients under 6 years old experienced no spontaneous bleeding episodes whilst on prophylaxis (n=22)4

The response to secondary prophylaxis was assessed once every 3 months by the investigator using a 3-point scale: excellent (no spontaneous bleeding of any kind, no change in dosing regimen necessary); effective (no spontaneous musculoskeletal bleeding, no change in dosing regimen necessary); or inadequate (inadequate prevention of bleeding requiring a change in dosing regimen).1

Rated by the investigator at 3-month intervals on a 3-point scale: excellent (prophylaxis treatment completely prevented spontaneous musculoskeletal bleeding, no change in dosing regimen necessary); effective (adequately prevented spontaneous musculoskeletal bleeding episodes as demonstrated by a lower than expected incidence of spontaneous musculoskeletal bleeding episodes); or inadequate (inadequate prevention of bleeding requiring a change in dosing regimen).2

On-demand treatment

On-demand treatment in PTPs

of 1,796 bleeding episodes were resolved with only 1 infusion (n=55)1

On-demand treatment in PUPs

of 997 bleeding episodes were resolved with only 1 infusion (n=54)2 

Surgery 

of responses were rated excellent or good (n=28)3,§

Haemostasis was rated as excellent or good in 34 out of 35 of the operative procedures. Response ratings are defined as follows: excellent if the response was as satisfactory, with as much and as rapid an improvement as the best responses with other factor IX 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 factor IX products for similar bleeds or procedures; moderate if the response was less than satisfactory and not as good as most responses seen with other factor IX products when used for similar bleeding episodes or similar procedures; or no response if no improvement at all was observed.3

§ 29% (8/28) of patients (9 operative procedures) received postoperative BeneFIX by continuous infusion.3 BeneFIX is not licensed for use by continuous infusion – please refer to the BeneFIX Summary of Product Characteristics for further information.5

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References
  1. Roth DA et al. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood 2001;98(13):3600–3606.
  2. Shapiro AD et al. The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B. Blood 2005;105(2):518–525.
  3. Ragni MV et al. Use of recombinant factor IX in subjects with haemophilia B undergoing surgery. Haemophilia 2002;8(2):91–97.
  4. Monahan PE et al. Safety and efficacy of investigator-prescribed BeneFIX prophylaxis in children less than 6 years of age with severe haemophilia B. Haemophilia 2010;16(3):460–468.
  5. BeneFIX (nonacog alfa) Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/6157/smpc.
PP-BEN-GBR-0390. March 2021

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PP-PFE-GBR-2688. December 2020

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