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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

ReFacto AF® in the real-world setting  

Real-world data suggest that rFVIII products like ReFacto AF®* are effective at preventing bleeds in everyday settings.

rFVIII products like ReFacto AF® are effective at preventing bleeds in everyday settings2

Data derived from a health-record based survey of European and US haematologists (n=501 patients with haemophilia A, 435 of whom were taking SHL rFVIII) suggest that rFVIII products like ReFacto AF® are effective at preventing bleeds in everyday settings.2  

66% of the overall group were on prophylactic rFVIII, the remainder received on-demand treatment. Information is not available on the proportion of patients receiving SHL rFVIII who were on on-demand treatment.2

No head-to-head trials comparing the efficacy of EHL vs. SHL factor replacement products have been reported.2 The available real-world data is of small sample size.1 Therefore, these data are subject to biases and other limitations.2  

**patients with bleeding event data

Patients with haemophilia A receiving SHL rFVIII

rFVIII products like ReFacto AF® are effective at preventing bleeds in everyday settings2

Data derived from a health-record based survey of European and US haematologists (n= 501 patients with haemophilia A, 66 of whom were taking EHL rFVIII) suggest that rFVIII products like ReFacto AF® are effective at preventing bleeds in everyday settings.2 

66% of the overall group were on prophylactic rFVIII, the remainder received on-demand treatment. Information is not available on the proportion of patients receiving EHL rFVIII who were on on-demand treatment.2

No head-to-head trials comparing the efficacy of EHL vs. SHL factor replacement products have been reported.2 The available real-world data is of small sample size.2 Therefore, these data are subject to biases and other limitations.2

​​​​​​​**patients with bleeding event data

Patients with haemophilia A receiving EHL rFVIII

The 2019/20 UKHCDO Annual Report demonstrated that the average international units (IUs) dispensed per haemophilia A patient in 2019/20 is greater in efmoroctocog alfa than in ReFacto AF®.3  

 Haemophilia statistics  

Prophylaxis in paediatric patients supports an active lifestyle, which may reduce bleed frequency and improve health-related quality of life.4 

A cross sectional, multi-site, study of boys aged 6–17 years (n=84) with haemophilia A or B*** that assessed physical performance, sporting activity and health-related quality of life found4:

Sedentary life styles had a negative impact on the subjective physical performance of children, while boys doing sport had a significantly better physical performance and health-related quality of life.4

Encouraging haemophilic boys to participate in sport has a direct impact on their overall health-related quality of life.4

***of any severity, current or past inhibitor.
†Health-related quality of life was assessed using age appropriate questionnaires including KINDL, Haemo-QoL and HEP-Test-Q

Children with haemophilia and sport

*Several other FVIII products were administered in this study.  

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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.5

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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.


Abbreviations
​​​​​​​

EHL, extended half-life; SHL, standard half-life.


References
  1. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Chhabra A et al. Blood Coagul Fibrinolysis 2020;31:186–192.  
  3. UKHCDO. Annual Report 2020 and Bleeding Disorder Statistics for the Financial Year 2019/2020. Available at: http://www.ukhcdo.org/wp-content/uploads/2021/03/UKHCDO-Annual-Report-2020-2019-20-Data_FINAL.pdf [Accessed September 2021].  
  4. Khair K et al. Haemophilia 2012;18:898–905.  
  5. Versloot O et al. Blood 2020;136(Suppl.1):21–22.  
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-0275. September 2021.

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PP-PFE-GBR-3863. November 2021

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