BeneFIX (nonacog alfa) Prescribing Information for Great Britain click here. BeneFIX (nonacog alfa) Prescribing Information for Northern Ireland click here.
Adverse event reporting can be found at the bottom of this page.
BeneFIX® (nonacog alfa) is recombinant coagulation factor IX indicated for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). BeneFIX® can be used for all age groups.1
BeneFIX® in the real-world setting
Real-world data suggest that rFIX products like BeneFIX®* are effective at preventing bleeds in everyday settings.2
rFIX products like BeneFIX® are effective at preventing bleeds in everyday settings2 |
Data derived from a health-record based survey of European and US haematologists (n=150 patients with haemophilia B, 114 of whom were taking SHL rFIX) suggest that rFIX products like BeneFIX® are effective at preventing bleeds in everyday settings.2 |
67% of the overall group were on prophylactic rFIX, the remainder received on-demand treatment. Information is not available on the proportion of patients receiving SHL rFIX who were on on-demand treatment.2
No head-to-head trials comparing the efficacy of EHL vs. SHL factor replacement products have been reported.2 The available real-world data is of small sample size, particularly for the FIX EHL groups.2 Therefore, these data are subject to biases and other limitations.2
Patients with haemophilia B receiving SHL rFIX
rFIX products like BeneFIX® are effective at preventing bleeds in everyday settings2 |
Data derived from a health-record based survey of European and US haematologists (n= 150 patients with haemophilia B, 36 of whom were taking EHL rFIX) suggest that rFIX products like BeneFIX® are effective at preventing bleeds in everyday settings.2 |
67% of the overall group were on prophylactic rFIX, the remainder received on-demand treatment. Information is not available on the proportion of patients receiving EHL rFIX who were on on-demand treatment.2
No head-to-head trials comparing the efficacy of EHL vs. SHL factor replacement products have been reported.2 The available real-world data is of small sample size, particularly for the FIX EHL groups.2 Therefore, these data are subject to biases and other limitations.2
Patients receiving EHL rFIX
The 2019/20 UKHCDO Annual Report demonstrated that the average international units (IUs) dispensed per haemophilia B patient in 2019/20 is greater in EHLs than SHLs.3
Haemophilia statistics
Joint bleeds are associated with impairment in normal activities.4,5
A post-hoc analysis of patient-reported outcomes confirms that during on-demand treatment, joint bleeds are associated with impairment in normal activities, and pain (as measured by the Brief Pain Inventory [BPI]).6 |
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Prophylaxis with BeneFIX® significantly decreases the annualised bleeding rate (ABR) in people with haemophilia B (p<0.0001) according to one randomised study.5 |
Joint bleeds and normal activities
Prophylaxis in paediatric patients supports an active lifestyle, which may reduce bleed frequency and improve health-related quality of life.7
A cross sectional, multi-site, study of boys aged 6–17 years (n=84) with haemophilia A or B† that assessed physical performance, sporting activity and health-related quality of life‡ found7:
Sedentary life styles had a negative impact on the subjective physical performance of children, whilst boys doing sport had a significantly better physical performance and health-related quality of life.7 |
|
Encouraging haemophilic boys to participate in sport has a direct impact on their overall health-related quality of life.7 |
†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.
Children with haemophilia and sport
*Several other FIX products were administered in this study.
Safety profile
BeneFIX® has a well-documented safety profile in both adults and children.1
** This is an optional area where footnotes can live.
Clinical efficacy
Access data on the clinical efficacy of BeneFIX® for on-demand treatment and prophylaxis.
** This is an optional area where footnotes can live.
ABR, annualised bleed rate; EHL, extended half-life; rFIX, recombinant factor IX; SHL, standard half-life.
References
- BeneFIX® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
- Chhabra A et al. Blood Coagul Fibrinolysis 2020;31:186–192.
- UKHCDO. Annual Report 2020 and Bleeding Disorder Statistics for the Financial Year 2019/2020. Available at: http://www.ukhcdo.org/wp-content/uploads/2021/03/UKHCDO-Annual-Report-2020-2019-20-Data_FINAL.pdf [Accessed September 2021].
- Buckner T et al. Eur J Haematol. 2018;100:592–602.
- Valentino L et al. Haemophilia 2014; 20:398–406.
- Shafer F et al. Haemophilia 2014;20:349–353.
- Khair K et al. Haemophilia 2012;18:898–905.
Adverse events should also be reported to Pfizer Medical Information on 01304 616161.
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