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ReFacto AF (moroctocog alfa) Prescribing Information for Great Britain click here. ReFacto AF (moroctocog alfa) Prescribing Information for Northern Ireland click here.
Adverse event reporting information can be found at the bottom of the page.


​​​​​​ReFacto AF® (moroctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ReFacto AF® is appropriate for use in adults and children of all ages, including newborns. ReFacto AF® does not contain von Willebrand factor, and hence is not indicated in von Willebrand's disease.1

The Pfizer journey so far: ReFacto AF® heritage

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

Pfizer milestones in haemophilia

The original ReFacto® (moroctocog alfa) was approved in 1999 - the first recombinant factor VIII product licensed for patients with haemophilia A.1

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

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How ReFacto AF® works

ReFacto AF® (moroctocog alfa) contains recombinant coagulation factor VIII, which has functional characteristics comparable to those of endogenous factor VIII.1

Find out more

Purification

The ReFacto AF® manufacturing process is completely albumin-free from cell culture to the end product.10

Read more

Safety profile

ReFacto AF® has a well-documented safety profile in adult patients. Paediatric safety profile is comparable to that of adults.1

Read more about safety

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


References
  1. ReFacto AF® 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(3):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. BeneFIX® 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 September 2021].
  10. Kelley B et al Haemophilia 2010;16(5):717–725.
  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-REF-GBR-0263. September 2021.

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PP-PFE-GBR-3863. November 2021

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