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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

Clinical efficacy​​​​​​​​​​​​​​

​​​​​​​Reliable efficacy when you and your patients need it most.2,3​​​​​​​

Prophylactic treatment in PTPs

Reduction in annual bleed rate (ABR) vs. on-demand in previously treated patients (PTPs). ReFacto AF® prophylaxis is more effective at preventing bleeds than on-demand treatment, with an 85% reduction of bleeds per year (median ABR: 3.4; n=154) achieved with prophylactic treatment.4*    

* ReFacto AF® is manufactured using the same cell line as ReFacto®5 and is bioequivalent to ReFacto® and pharmacokinetically equivalent to a full-length recombinant factor VIII (FLrFVIII) comparator,1 so it is expected to behave in the same way.  

Prophylaxis

On-demand treatment in PTPs

of 10,882 bleeding episodes were treated effectively with only 1 infusion (n=113).2,3

On-demand treatment in previously untreated patients (PUPs)    

of 2,715 bleeding episodes were treated effectively with only 1 infusion (n=101).2,3  

Surgery    

of infusions administered were rated as excellent or good by the surgeon and treating physician (38 patients; 48 surgical procedures; 496 infusions during or after surgery).2†  

†​​​​​​ Excellent rating: achievement of comparable haemostasis to that expected after similar surgery in a non-haemophilic patient. Good rating: prolonged time to haemostasis with somewhat increased bleeding compared with that expected after similar surgery in a non-haemophilic patient.2  

On-demand treatment

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Safety profile

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

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Contact a member of the Pfizer haemophilia team.

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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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References
  1. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Lusher JM et al. Haemophilia 2003;9:38–49.  
  3. Lusher JM, Roth D. Haemophilia 2005;11:292–293.  
  4. Parra Lopez R et al. Thromb Haemost. 2015;114(4):676–684.  
  5. Kelley B et al. Haemophilia 2010;16(5):717–725.  
  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-0270. September 2021.

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*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021

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