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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

Purification

ReFacto AF® (moroctocog alfa) is manufactured and purified to be free from the risk of human blood-borne pathogen transmission.1–3

Albumin-free state-of-the-art manufacturing process

Albumin-free

Synthetic ligand

Nanofiltration

The ReFacto AF® purification process

ReFacto AF® (moroctocog alfa) manufacturing removes large viruses, such as retroviruses.2

Manufacturing changes to ReFacto AF® represent a major step in the progress of haemophilia treatment.4 Any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation has been eliminated,2,3 expanding on the current viral-safety program.4

Albumin-free

The process is completely albumin-free and is completely free of exogenous human and animal proteins.2-4

Synthetic ligand

​​​​​​​ReFacto AF® is purified in several successive chromatographic steps, which further reduce
process-related impurities.2–4

Nanofiltration

​​​​​​​Nanofiltration step to remove viruses.2-4

The ReFacto AF® manufacturing process is completely albumin-free from cell culture to the end product.2  

​​​​​​​All exogenous animal proteins have been eliminated from the manufacturing process.2-4  

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Heritage

ReFacto AF® (and ReFacto®) have more than 20 years’ experience in haemophilia A, building on a proud heritage in haemophilia care.1

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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

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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.

Clinical efficacy

Access data on the clinical efficacy of ReFacto AF® for on-demand treatment and prophylaxis.

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

Flexible dosing

No two days are the same. No two patients are the same. ReFacto AF® offers frequent, flexible dosing so your patients are covered for everyday life.1,5,6

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** 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. Kelley BD et al. Haemophilia 2010;16(5):717–725.
  3. Kelley BD et al. Biotechnol Bioeng. 2004;87(3):400–412.
  4. Marchesini E et al. Clinical Investigation 2011;1(2):305–316.
  5. Shapiro AD et al. Haemophilia 2005;11:571–582.
  6. Berntorp E and Andersson N. Semin Thromb Hemost 2016;42:518–525.
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-0265. September 2021.

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PP-PFE-GBR-3863. November 2021

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