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Click here for BeneFIX® (nonacog alfa) Prescribing Information.  Adverse event reporting information can be found at the bottom of the page.

BeneFIX has a favourable safety profile

Safety profile 

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

  • Headache, cough, pyrexia – very common (≥10%)

  • Hypersensitivity, dizziness, dysgeusia, phlebitis, flushing, vomiting, nausea, rash, urticaria, chest discomfort, infusion-site reaction, infusion-site pain – common (≥1% to <10%)

Low inhibitor formation

Data from more than 11,000 infusions of BeneFIX demonstrate that inhibitor development and allergic reactions were low 2,3:

  • 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 that there is no difference in the frequency of allergic reactions or inhibitor development in patients receiving BeneFIX versus those receiving plasma-derived factor IX concentrates3

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Find out about the BeneFIX efficacy

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Find out about BeneFIX dosing

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References
  1. BeneFIX (nonacog alfa) Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/6157/smpc.
  2. Rendo P et al. 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.
  3. 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(3):494–499.
PP-BEN-GBR-0391. March 2021

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