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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

Terminal half-lives in haemophilia A  

Not all half-lives are the same in haemophilia A, resulting in 1 in 3 patients not receiving their desired improvement.2  

Each patient with haemophilia A has an individual pharmacokinetic profile that must be taken into consideration when making a decision regarding their treatment.2    

A recent analysis of 649 patients (1298 infusions) with severe haemophilia (89% haemophilia A) revealed2:    

  • At a group level, terminal half-life* (THL) extension for haemophilia A was observed when switching from a standard half-life (SHL) to an extended half-life (EHL) factor VIII (FVIII) for both children and adults with the median increasing by 4.1 hours (interquartile range (IQR): 2.0–6.7)  
  • ​​​​​​​However, 27% of the patients saw less than 20% improvement and 10% of the patients had a shorter THL while taking an EHL compared to the THL of SHL FVIII​​​​​​  

Additional analysis of 4832 (2222 children, 2610 adults) patients with severe haemophilia (89% haemophilia A) confirmed3:    

  • Median THL was longer in EHL at 15.1 hours (IQR: 12.0–19.0) vs. 11.1 hours (8.8–14.2) in SHL FVIII for both children and adults, resulting in a median increase of 4.0 hours.    

It also showed that for patients with severe haemophilia A3:    

  • The THL was 2.2 hours shorter in patients with blood group O, independent of concentrate type (48% of UK population has blood group O4).  
  • ​​​​​​​In people with a positive inhibitor history, the THL was decreased by 1.3 hours.  

*  Terminal half‐life (THL) is the time required for the plasma concentration of medicine to fall by 50% during the terminal phase, and not the time required to eliminate half the administered dose.5  

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ReFacto AF® in the real-world setting

rFVIII products like ReFacto AF® are effective at preventing bleeds in everyday settings.6

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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.

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.


References
  1. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Versloot O et al. Blood 2020;136(Suppl.1):21–22.  
  3. Versloot O et al. Oral session 322 at the 62nd ASH Annual Meeting and Exposition 2020. Available at: https://ash.confex.com/ash/2020/webprogram/Paper141801.html [Accessed September 2021].  
  4. NHS. Blood groups. Available at: https://www.nhs.uk/conditions/blood-groups/ [Accessed September 2021].  
  5. Toutain P, Bousquet-Mélou A. J Vet Pharmacol Ther. 2004;27(6):427–439.  
  6. Chhabra A et al. Blood Coagul Fibrinolysis 2020;31:186–192.  
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-0277. September 2021.

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PP-PFE-GBR-3863. November 2021

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