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DosingRecommended dose modificationsDose Administration

Clinical Efficacy 

BeneFIX® offers efficacy when you and your patients need it most.1-3

  

BeneFIX® proven efficacy across a wide range of patients,1,4* including paediatric patients.2-5

  

Prophylaxis

  

BeneFIX® has proven efficacy in prophylaxis1,2

  

  

On-demand Treatment

  

  

On-demand Treatment

  

  

Surgical Efficacy

  


Overall, 96.7% of responses were rated excellent or good in PUPs receiving BeneFIX® and undergoing surgery.2

A total of 30 surgical procedures including 12 permanent venous access placements, 7 circumcisions, 1 dental procedure and 10 other procedures.2

    

Study description (PTPs)

    

A 20-centre international trial was conducted in PTPs with severe or moderate (<5 IU/dL FIX activity) hemophilia B. Participants received rFIX for PK studies, treatment of or prophylaxis against haemorrhage, or surgical hemostasis, and were assessed at 3-month intervals for 2 years.1

   

Study description (PUPs)

    

A multicentre, 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 (2 years, up to a maximum of 5 years or 100 exposure days) 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 authorisation from the sponsor.2

    

BeneFIX® has proven efficacy in surgery3

    

   

Activity and Joint Health

  

  

Higher and more frequent peak factor levels may be needed for some patients.9
The importance of peak and trough levels in hemophilia patients is still not clearly understood. However, studies suggest that higher trough levels and greater area under the curve may correlate to fewer bleeds, especially in joints.8
In patients with more sedentary lifestyles, longer doses may be acceptable.9
In patients with a less than average half-life prolongation, target joints or more on-the move lifestyles, higher and more frequent peak factor levels may be beneficial for sufficient bleed protection.9

 

The role of peak and trough levels in prophylaxis10,11
(For illustrative purposes only)
 

Prophylaxis 2x per week (SHL)

  

  

Adapted from Mahdi AJ, et al. 2015; Powell JS, et al. 2013.

  

Prophylaxis 1x per week (EHL)

  

  

Adapted from Mahdi AJ, et al. 2015; Powell JS, et al. 2013.

  

Known benefits of early prophylaxis

  • Patients who started prophylaxis early (<4 years) is associated with better joint outcomes13

  • Patients who start prophylaxis soon after the first joint bleed show little arthropathy in adulthood13

  • Preventing or reducing the clinical impact of haemophilic arthropathy by prophylaxis means14,15:

    • Enabling normal life and psychosocial development
    • Possibility of physical activities
    • Possibility of regular school attendance

    • Social and work opportunities

  

  

*Patients with moderate or severe hemophilia B (aged 3-69 years), previously untreated patients, previously treated with high-purity, monoclonal antibody-purified factor IX (pdFIX).
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
§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 FIX 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 FIX products for similar bleeds or procedures; moderate if the response was less than satisfactory and not as good as most responses seen with other FIX products when used for similar bleeding episodes or similar procedures; or no response if no improvement at all was observed.3
ǁOverall, 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® LPD for further information.7
A target joint is a joint in which 3 or more spontaneous bleeds have occurred within a consecutive 6-month period.12

  

EHL, extended half-life; FIX, factor IX; LPD, local prescribing document; PK, pharmacokinetic; PTP, previously treated patient; PUP, previously untreated patient; rFIX, recombinant factor IX; SHL, standard half-life.

  

References:

Roth DA, Kessler CM, Pasi KJ, 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.Shapiro AD, Di Paola J, Cohen A, 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.Ragni MV, Pasi KJ, White GC, et al. Use of recombinant factor IX in subjects with haemophilia B undergoing surgery. Haemophilia. 2002;8(2):91-97.Lambert T, Recht M, Valentino LA, et al. Reformulated BeneFix: efficacy and safety in previously treated patients with moderately severe to severe haemophilia B [published correction appears in Haemophilia. 2007 Jul;13(4):450]. Haemophilia. 2007;13(3):233-243. Recht M, Pollmann H, Tagliaferri A, Musso R, Janco R, Neuman WR. A retrospective study to describe the incidence of moderate to severe allergic reactions to factor IX in subjects with haemophilia B. Haemophilia. 2011;17(3):494-499.Monahan PE, Liesner R, Sullivan ST, Ramirez ME, Kelly P, Roth DA. 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.BeneFIX. Local prescribing document. Pfizer India. LPDBEN092021.Dunn A. The long and short of it: using the new factor products. Hematology Am Soc Hematol Educ Program. 2015;2015:26-32.Collins P, Chalmers E, Chowdary P, et al. The use of enhanced half-life coagulation factor concentrates in routine clinical practice: guidance from UKHCDO. Haemophilia. 2016;22(4):487-498.Mahdi AJ, Obaji SG, Collins PW. Role of enhanced half-life factor VIII and IX in the treatment of haemophilia. Br J Haematol. 2015;169(6):768-776.Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323.Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020;26(Suppl 6):1-158.Fischer K, van der Bom JG, Mauser-Bunschoten EP, et al. The effects of postponing prophylactic treatment on long-term outcome in patients with severe hemophilia. Blood. 2002;99(7):2337-2341.Wu R, Luke KH, Poon MC, et al. Low dose secondary prophylaxis reduces joint bleeding in severe and moderate haemophilic children: a pilot study in China. Haemophilia. 2011;17(1):70-74.Chuansumrit A, Isarangkura P, Hathirat P. Prophylactic treatment for hemophilia A patients: a pilot study. Southeast Asian J Trop Med Public Health. 1995;26(2):243-246.

  

PP-BEN-IND-0025 22/07/22

Surgical efficacy

Activity and Joint Health​​​​​​​

Efficacy and Safety

   

About

BeneFIX® is a recombinant coagulation FIX. Find out how BeneFIX® works

Learn more

   

Dosing

BeneFIX® provides dosing options based on individual needs

Learn more

   

Efficacy and Safety

Proven efficacy and protection across dosing regimen

Review efficacy  profile

   

Real-world Data

See how BeneFIX® performs in real-life settings.

Review real-world data

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