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Prophylaxis On-Demand Bleed Control Dosing options Clinical History Important Safety Information Abbreviated Prescribing Information
Clinical History

BeneFIX in PTPs

BeneFIX in children < 6 years

BeneFIX in surgery

BeneFIX* experience in PTPs: (Roth DA, et al. 2001)

Aim / overview:

  • Evaluate the safety and efficacy of BeneFIX in PTPs with severe and moderate haemophilia B for the treatment or prevention of bleeding episodes2
  • The study comprised pharmacokinetic assessment, assessment of thrombogenicity and safety and efficacy during home treatment and management of surgical procedures. The PK assessment was repeated every 6 months, with routine clinical and laboratory evaluations at 3-month intervals. The planned study duration for each participant was 2 years2


56 patients from at 20 sites throughout North America and Europe were enrolled and received BeneFIX.2


  • A total of 2758 infusions were administered for on-demand treatment of 1796 hemorrhages2.
  • All bleeding episodes were controlled exclusively with BeneFIX using standard dosing intervals2.
  • Most bleeding episodes (80.9%) were controlled with one infusion2                                                         

BeneFIX is clinically effective in the treatment and prevention of bleeding in individuals with hemophilia B.2

Reformulated BeneFIX* experience in PTPs: (Lambert T, et al. 2007)

Aim / overview:

  • To evaluate the safety and efficacy of reformulated BeneFIX for treatment and prevention of       haemorrhages in PTPs with moderately severe to severe haemophilia B3  
  • To evaluate bioequivalence between BeneFIX and reformulated BeneFIX3  
  • Double-blind, randomised, PK crossover study3                                                                                                                                                                           


34 subjects were randomised to receive a single 75 IU/ kg dosage of BeneFIX or reformulated BeneFIX3


  • 77/95 bleeds (81.1%) were resolved with a single infusion of reformulated BeneFIX3 
  • Treatment response to the first reformulated BeneFIX infusion was rated “excellent” or “good  85.3% of haemorrhages        
  • More than half of subjects using reformulated BeneFIX for routine prophylaxis (11 of 17, 64.7%)    had no spontaneous bleeding episodes during their 6–12 month-course of prophylactic treatment3.

BeneFIX has been reformulated and the reformulated product is effective for treatment of haemophilia B.3

BeneFIX* experience in PTPs: (Korth-Bradley JM, et al. 2016)

Aim / overview:

  • To better characterize PK parameters, both initially and after repeated BeneFIX exposure with   usual hemophilia B care (including on-demand treatment, routine prophylaxis, and surgical prophylaxis) and collect additional efficacy and safety data4                                                                                                                                                                                                                                                                                                                                                                                  
  • To collect additional efficacy and safety data4                                                                                                                                                                                                                                                                                                                                                                                                                
  • To examine the relationship between patient body weight and BMI and Cmax of FIX activity4                                                                                                                                                                                                                                   
  • Prospective, open-label, non-randomised, multinational, multicentre study4               


  • 23 patients were enrolled; 21 of those had ≥30 exposure days to BeneFIX and were evaluable for   efficacy4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
  • Eligible participants were aged at least 12 years, had moderately severe to severe hemophilia B     (FIX activity [FIX:C] ≤ 2%)4


  • A total of 103 bleeding events were reported for patients receiving on-demand treatment; 54      were  spontaneous events and 49 were injury related4      
  • 73 bleeding events (71%) occurred in 9 patients while following the on-demand treatment                regimen (monthly bleeding rate, 1.2)4      
  • 30 bleeding events (13 spontaneous and 17 due to injury) were reported in 13 patients while using   routine prophylaxis (mean monthly bleeding rate, 0.4) 
  • Regardless of location, 54 of the103 bleeding events (52%) resolved with a single infusion4      
  • Ratings of response‡ to the initial infusion for on-demand treatment were “excellent” or “good” for 87(84%) of the 103 bleeding events4

BeneFIX was effective for on-demand treatment, routine prophylaxis, and surgical prophylaxis in previously treated patients with moderately severe to severe hemophilia B.4

*On demand dose: The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dL (range from 0.4 to 1.4 IU/ dL) in patients ≥ 12 years. 

The required dosage is determined using the following formula: Number of factor IX IU required = body weight (in kg) X desired factor IX increase (%) or (IU/dL) X reciprocal of observed recovery

Prophylaxis dose: BeneFIX may be administered for long term prophylaxis against bleeding in patients with severe haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for PTP was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days.1

Excellent: dramatic response with abrupt pain relief and clear reduction in joint or haemorrhage site size; Good: pain relief or reduction in haemorrhage site size which was delayed or required additional infusion for resolution.3

Response was evaluated by the patient or caregiver or by the investigator using a 4-point scale.4     

BMI: body mass index; Cmax: peak plasma concentration; FIX: factor IX; IU: international unit; PK: pharmacokinetic; PTP: previously treated patient

References:Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020Roth 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.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.Korth-Bradley JM, Rendo P, Smith L, Altisent C. Pharmacokinetics, Efficacy, and Safety of Nonacog Alfa in Previously Treated Patients with Moderately Severe to Severe Hemophilia B. Clin Ther. 2016;38(4):936-944.

BeneFIX experience in children <6 years (PUPs and PTPs): (Monahan PE, et al. 2010)

Aim / overview:

  • Evaluate safety and efficacy of rFIX for usual haemophilia B care in children <6 years old, incluse    in the setting of routine prophylaxis2                                                                                                                                                               
  • International, open-label, multi-centre, prospective study2                                                                                                                                        


  • Eligible patients had severe haemophilia B (FIX activity ≤1%)2                                                                                
  • 25 patients received at least one dose of BeneFIX2                                                                                                                                                                                                                                              


  • 77% of children on routine prophylaxis* with BeneFIX had no spontaneous hemorrhages and seven patients (32%)                                                                                                                 
  • had no bleeding episodes at all2                                                                                                                                                               
  • 20/22 patients (91%) had ≤1 joint hemorrhage during the course of prophylaxis2                                                                                                                                                                                                                                                                         

Regular BeneFIX infusions effectively controlled and prevented hemorrhages in the 22 efficacy evaluable subjects, all of whom were prescribed routine prophylaxis.2

*Mean dosage in pediatric population (± standard deviation) for prophylaxis was 64.6 (±21.3) IU/kg.Please refer to the local label for approved dosages.                                                                                                  

FIX: factor IX; IU: international unit; PTP: previously treated patient; PUPs: Previously untreated patients.

References:Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.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 experience in surgery: (Ragni MV, et al. 2002)

Aim / overview:

  • Determine the safety and efficacy of BeneFIX in the surgical setting, with acute, short-term higher intensity treatment2


BeneFIX was evaluated in 28 subjects with FIX deficiency (including 26 with mild, moderate or severe haemophilia B and two haemophilia B carriers) undergoing 36 surgical procedures2


  • The clinical responses to rFIX were rated excellent or good by subjective assessment by the           physician/ surgeon or by the subject in 34 of 35 procedures (97%). 
  • Physicians rated the response to BeneFIX as “excellent” or “good” in all pre- and post-operative      cases*2

BeneFIX was found to be effective in achieving haemostasis in subjects with FIX deficiency undergoing surgery2

*Excellent: 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: 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.2

FIX: factor IX; rFIX: recombinant factor IX.

References:Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.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.

Approval No. : BV0098A2259/032022

Invalidation Date: 17/02/2025

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