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Prophylaxis On-Demand Bleed Control Dosing options Clinical History Important Safety Information Abbreviated Prescribing Information
ProphylaxisBeneFIX Prophylactic Treatment in PUPs with hemophilia B
of responses were rated as excellent* (157 of 172) indicating that prophylaxis treatment completely prevented spontaneous musculoskeletal bleeding2
BeneFIX Prophylactic Treatment in PTPs with hemophilia B
Prophylactic Treatment in PTPs
of prophylaxis regimen responses were rated as excellent or effective†3
Paediatric Patients
of patients under 6 years old experienced no spontaneous hemorrhages whilst on prophylaxis (n=17)4

*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
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).3

FIX: factor IX; PTP: previously treated patient; PUP: previously untreated patient.


  1. Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.
  2. 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.
  3. 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.
  4. Monahan PE, Leisner 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.
Approval No. : BV0098A2259/032022

Invalidation Date: 17/02/2025

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