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Choosing BeneFIXChoosing BeneFIXChoosing BeneFIXPersonalised dosing Product InformationProduct InformationEfficacy & SafetyAdministration & StorageSupport & ResourcesSupport & ResourcesMaterialsVideosOrdering BeneFIXContact Us
For BeneFIX® (nonacog alfa) Prescribing Information for Great Britain and Northern Ireland click here.
Adverse event reporting information can be found at the bottom of the page.
Clinical efficacy & safety profile

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
 

EfficacyRepeated prophylaxis exposure


Prophylactic treatment in PTPs  

 93%  of responses were rated as excellent or effective (n=47).2*

 

Prophylactic treatment in PUPs  

 91%  of responses were rated as excellent (n=42), indicating that spontaneous muscoloskeletal bleeding was prevented.3†
 

Paediatric patients  

 77%  of patients under 6 years old with severe Haemophilia B experienced no spontaneous bleeding episodes while on prophylaxis (n=22).4

image
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).2Rated 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).3
On-demand treatment and surgery

On-demand treatment PTPs  

 81%  of 1796 bleeding episodes were resolved with only 1 infusion (n=55).2

 

On-demand treatment PUPs  

 75%  of 997 bleeding episodes were resolved with only 1 infusion (n=54).3

 

Surgery 

 97%  of responses were rated excellent or good (n=28).

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 factor IX 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 factor IX products for similar bleeds or procedures; moderate if the response was less than satisfactory and not as good as most responses seen with other factor IX products when used for similar bleeding episodes or similar procedures; or no response if no improvement at all was observed.529% (8/28) of patients (9 operative procedures) received postoperative BeneFIX® by continuous infusion.5 BeneFIX® is not licensed for use by continuous infusion – please refer to the BeneFIX® Summary of Product Characteristics for further information.1
image
Safety Profile

Adverse reactions cited as very common (≥10%): headaches, cough and pyrexia1

Adverse reactions cited as common (≥1% to <10%): hypersensitivity, dizziness, dysgeusia, phlebitis, flushing, vomiting, nausea, rash, urticaria, chest discomfort, infusion-site reaction and pain1

Adverse reactions cited as uncommon (≥0.1% to <1%): Infusion-site cellulitis, Factor IX inhibition, somnolence, tremor, visual impairment, tachycardia, hypotension, renal infarct1
 

  • Data collected from 8 interventional studies using on-demand, prophylactic and preventative regimens in patients with Haemophilia B, showed no clinical symptoms of thrombotic events and no clinically relevant changes in coagulation markers were reported (n=221).6†
  • In a retrospective study, only  1.84%  of patients had inhibitor formation when taking BeneFIX® (n=163)7
Between baseline and end-of-study testing in a retrospective, post-hoc, pooled analysis (N=221).6
For more safety data, please refer to the BeneFIX Summary of Product Characteristics before prescribing the treatment to your patients.
Explore More
Personalised dosing 

Access information to help determine adequate dosing for your patient and improve their peak control.

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Administration & Storage

Find out more on how to administer and store BeneFIX using our R2 device.

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Contact us

Contact us for more information on BeneFIX and download our FAQ for supply and stock related queries.

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Abbreviations: 

PTP, previously treated patients; PUP, previously untreated patients. 

References

BeneFIX® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.Roth DA et al. Blood 2001;98(13):3600–3606.Shapiro AD et al. Blood 2005;105(2):518–525.Monahan P et al. Haemophilia 2010;16(3):460–468. Ragni M et al. Haemophilia 2002;8(2):91–97.Rendo P, et al. Thrombogenicity evaluation in 221 patients with haemophilia B treated with nonacog alfa. Blood Coagul Fibrinolysis. 2018;29:81–86.Recht M, et al. A retrospective study to describe the incidence of moderate to severe allergic reactions to factor IX in subjects with haemophilia B. Haemophilia. 2011;17:494–499.
PP-BEN-GBR-0635. August 2023

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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