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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  

The Pfizer journey so far: BeneFIX® heritage  

With more than 20 years’ experience treating patients with haemophilia B,1 BeneFIX® is building on Pfizer’s proud heritage in haemophilia care.   

Pfizer milestones in haemophilia

BeneFIX® (nonacog alfa) was approved in 19971 - the first recombinant factor IX product licensed for patients with haemophilia B.2  

​​​​​​​Pfizer continue to invest in the research and development of haemophilia treatment.   

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How BeneFIX® works  

BeneFIX® (nonacog alfa) contains recombinant coagulation factor IX, which has functional characteristics comparable to those of endogenous factor IX.1

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Purification

The process used to manufacture BeneFIX® eliminates the risk of blood-borne pathogens, such as HIV, hepatitis viruses, parvovirus and prions that cause variant Creutzfeldt-Jakob disease.10

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Safety profile

BeneFIX® has a well-documented safety profile in both adults and children.1

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


References
  1. BeneFIX® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Funding Universe. Genetics Institute, Inc. history. Available at: http://www.fundinguniverse.com/company-histories/genetics-institute-inc-history/ [Accessed September 2021].  
  3. CenterWatch. BeneFIX (coagulation Factor IX (recombinant)). Available at: https://www.centerwatch.com/directories/1067-fda-approved-drugs/listing/3222-benefix-coagulation-factor-ix-recombinant [Accessed September 2021].  
  4. BioSpace. 2007. Available at: www.biospace.com/article/releases/wyeth-receives-fda-approval-for-new-benefix-features-that-provide-hemophilia-b-patients-a-simpler-and-more-convenient-preparation-process-for-recombin [Accessed September 2021].  
  5. Lambert T et al. Haemophilia 2007;13:233–243.  
  6. European Medicines Agency. EPAR summary for the public. https://www.ema.europa.eu/en/documents/overview/refacto-af-epar-summary-public_en.pdf [Accessed September 2021].  
  7. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  8. European Medicines Agency. BeneFIX EPAR – procedural steps taken and scientific information after the authorisation. Available at: https://www.ema.europa.eu/en/documents/procedural-steps-after/benefix-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf [Accessed September 2021].  
  9. Pfizer. Pfizer Expands Rare Disease Research with Establishment of Gene Therapy Platform. Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_expands_rare_disease_research_with_establishment_of_gene_therapy_platform [Accessed June 2021]  
  10. Adamson S et al. Semin Hematol. 1998;35(2 Suppl 2):22–27.  
  11. European Medicines Agency. ReFacto AF EPAR – procedural steps taken and scientific information after the authorisation. Available at: https://www.ema.europa.eu/en/documents/procedural-steps-after/refacto-af-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf [Accessed September 2021].   
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-0485. September 2021.

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PP-PFE-GBR-3863. November 2021

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