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
Explore more
Clinical efficacy
Access data on the clinical efficacy of BeneFIX® for on-demand treatment and prophylaxis.
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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- BeneFIX® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
- Rendo P et al. Blood Coagul Fibrinolysis 2015;26(8):912–918.
- Recht M. Haemophilia. 2011 May;17(3):494-499.
- Rendo et al. Blood Coagul Fibrinolysis 2018;29:81–86.
- Chhabra A et al. Blood Coagul Fibrinolysis 2020;31(3):186–192.
Adverse events should also be reported to Pfizer Medical Information on 01304 616161.
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