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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

How ReFacto AF® works

ReFacto AF® (moroctocog alfa AF-CC) contains B-domain deleted recombinant coagulation factor VIII, and has functional characteristics comparable to those of endogenous factor VIII. As factor VIII activity is greatly reduced in patients with haemophilia A, replacement therapy is necessary.1​​​​

How does ReFacto AF® replace factor VIII?

Haemophilia A is a sex-linked hereditary coagulopathy resulting from decreased factor VIII:C, that causes profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of trauma. Replacement therapy increases the plasma factor VIII levels, temporarily correcting the factor deficiency and, consequently, the bleeding tendencies.1

When infused into a patient with haemophilia A, factor VIII binds to the circulating von Willebrand factor. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin, and a clot is formed.1

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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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Purification

The ReFacto AF® manufacturing process is completely albumin-free from cell culture to the end product.3

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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

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** 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.


References
  1. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Bowen D. Mol Pathol. 2002;55(2):127–44.
  3. Kelley BD et al. Haemophilia 2010;16(5):717–725.
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-0264. September 2021.

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PP-PFE-GBR-3863. November 2021

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