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BeneFIX (nonacog alfa) Prescribing Information for Great Britain click here. BeneFIX (nonacog alfa) Prescribing Information for Northern Ireland click here.
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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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Heritage

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

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BeneFIX® in the real-world setting  

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

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References
  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 www.mhra.gov.uk/yellowcard 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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PP-PFE-GBR-3863. November 2021

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