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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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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® has a well-documented safety profile1  

Safety profile

​​​​​​​The most common adverse reactions reported in clinical trials of previously treated patients (PTPs) and identified in post-marketing use were1:      

  • Very common (≥10%): Headache, cough, pyrexia
  • Common (≥1% to <10%): Hypersensitivity, dizziness, dysgeusia, phlebitis, flushing, vomiting, nausea, rash, urticaria, chest discomfort, infusion-site reaction, infusion-site pain      
  • ​​​​​​​Uncommon (≥0.1% to <1%): Infusion-site cellulitis, Factor IX inhibition, somnolence, tremor, visual impairment, tachycardia, hypotension, renal infarct 

Low inhibitor formation  

​​​​​​​Data from more than 11,000 infusions of BeneFIX® demonstrate that inhibitor development and allergic reactions were low2,3:    

  • Results of pooled safety data from 6 prospective studies showed that 1.2% of patients developed inhibitors on BeneFIX® (5/412)2                    
    • 4 of these patients also exhibited an allergic-type manifestation.    
  • Results from a retrospective study suggest there is no difference in the frequency of allergic reactions or inhibitor development in patients receiving BeneFIX® vs. those receiving plasma-derived factor IX concentrates3  ​​​​​​​

Thrombotic events4  

Thrombotic event and coagulation marker data collected from 8 interventional studies utilising on-demand, prophylactic, and preventive regimens in patients with haemophilia B (n=221) showed:    

  • No clinical thrombotic events were reported    
  • ​​​​​​​No patient experienced clinically relevant changes in coagulation markers between baseline and end-of-study testing  

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Clinical efficacy

Access data on the clinical efficacy of BeneFIX® for on-demand treatment and prophylaxis.

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BeneFIX® has more than 20 years’ experience in haemophilia B; building on a proud heritage in haemophilia care.1  

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** This is an optional area where footnotes can live.

BeneFIX® in the real-world setting  

rFIX products like BeneFIX® are effective at preventing bleeds in everyday settings.5

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** This is an optional area where footnotes can live.

  1. BeneFIX® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Rendo P et al. Blood Coagul Fibrinolysis 2015;26(8):912–918.  
  3. Recht M. Haemophilia. 2011 May;17(3):494-499.
  4. Rendo et al. Blood Coagul Fibrinolysis 2018;29:81–86.  
  5. Chhabra A et al. Blood Coagul Fibrinolysis 2020;31(3):186–192.   
Adverse events should be reported. Reporting forms and information can be found at or search for MHRA Yellow Card in the Google Play or Apple App Store.
​​​​​​​Adverse events should also be reported to Pfizer Medical Information on 01304 616161.

PP-BEN-GBR-0493. September 2021

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*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021



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