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AboutAboutHeritageMechanism Of ActionPatient ProfilesStable SHL PatientsPatient on the MovePatients Currently Taking an EHLPatient Actively Involved in SportAboutPurification ProcessDosingRecommended Dosing SchedulesProphylaxisOn-demandAdministrationDose AdministrationEfficacy and SafetyEfficacy and SafetyClinical EfficacySafety ProfileMonitoringPatient Reported OutcomesReal-world dataSupport & ServicesSupport & ServicesPrescribing InformationMaterialsVideosLatest ArticlesEvents
DosingRecommended dose modificationsDose Administration

Patient-reported Outcomes

Enabling your patients to make the most of their lives1-7

  •  Efficacy that is established for prophylaxis, on-demand and surgery1-4
  • A favourable safety profile with low inhibitor formation5-7,*
  • Dosing flexibility through the broad range of doses (250, 500, 1000, 2000 and 3000 IU) enables FIX coverage for your patients in their everyday life5
  • Convenient storage options: Storage flexibility through room temperature storage (<30 ⁰C). Do not freeze5

Joint bleeds are associated with impairment in day-to-day activities8

  

Patients with hemophilia commonly experience recurrent bleeding into joints that may cause pain and arthropathy that can impact their quality of life.8

Recurrent bleeding into joints (haemarthrosis) is common in individuals with hemophilia and may cause pain and arthropathy.8

Patients reporting pain are more likely to experience anxiety and depression, worse health status and
functional impairments.9

In the prophylaxis of PTPs, 93% of responses were rated as excellent or effective (n=47).1,†

In the prophylaxis of PUPs, 91% of responses were rated as excellent (n=42), indicating that spontaneous
musculoskeletal bleeding was prevented.2

  

Children With Hemophilia and Sport

  

Prophylaxis in paediatric patients supports an active lifestyle, which may reduce the bleed frequency and improve the health-related quality of life.10

A cross-sectional, multisite, study of boys aged 6 to 17 years (n=84) with hemophilia A or B§ that assessed physical performance, sporting activity and health-related quality of life found the following10,¶:

  

Bleeding has a variable impact on the lives of adolescent boys with hemophilia, but is most obvious in those who play sport and who have to reduced or limit their participation because of bleeding. These boys recognized that prophylaxis offered them protection from bleeding, the older and more sporty boys understood the need for tailored prophylaxis around 'risk' activities such as sport or events away from home.10

  


Encouraging haemophilic boys to participate in sport has a direct impact on their overall health-related quality of life.10

  

  

*Results of pooled safety data from 6 prospective studies encompassing more than 11,000 infusions of [BeneFIX®] showed that 1.2% of patients experienced inhibitors on BeneFIX® (5/412). This was considered low by study investigators.7
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
§Of any severity, current or past inhibitor.
Health-related quality of life was assessed using age-appropriate questionnaires including KINDL, Haemo-QoL and HEP-Test-Q.

  

FIX, factor IX; Haemo-QoL, Hemophilia-Specific Quality of Life; HEP-Test-Q, Hemophilia & Exercise Project-Test-Questionnaire; IU, international unit; KINDL, German questionnaire for measuring quality of life in children and adolescents; PTP, previously treated patient; PUP, previously untreated patient.

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.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.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.Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015;26(8):912-918.Buckner TW, Witkop M, Guelcher C, et al. Impact of hemophilia B on quality of life in affected men, women, and caregivers-Assessment of patient-reported outcomes in the B-HERO-S study. Eur J Haematol. 2018;100(6):592-602.Witkop M, Neff A, Buckner TW, et al. Self-reported prevalence, description and management of pain in adults with haemophilia: methods, demographics and results from the Pain, Functional Impairment, and Quality of life (P-FiQ) study. Haemophilia. 2017;23(4):556-565.Khair K, Gibson F, Meerabeau L. The benefits of prophylaxis: views of adolescents with severe haemophilia. Haemophilia. 2012;18(3):e286-e289.

  

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

Real-world Data

See how BeneFIX® performs in real-life settings.

Review real-world data

Efficacy and Safety

  

About

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

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Dosing

BeneFIX® provides dosing options based on individual needs

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Real-world Data

See how BeneFIX® performs in real-life settings.

Review real-world data

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