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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® has a well-documented safety profile1

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

Safety profile

​​​​​​​The adverse reactions reported in pooled clinical trials with 765 subjects were1:    

  • Very common (≥10%): Factor VIII inhibitors in PUPs, headache, cough, arthralgia and pyrexia.  
  • Common (≥1% to <10%): Decreased appetite, dizziness, haemorrhage, haematoma, diarrhoea, vomiting, abdominal pain, nausea, urticaria, rash, pruritus, myalgia, chills, catheter-site-related reaction, antibody test positive and anti-factor VIII antibody test positive.    
  • ​​​​​​​Uncommon (≥0.1% to <1%): Factor VIII inhibitors in PTPs, anaphylactic reaction, neuropathy peripheral, somnolence, dysgeusia, angina pectoris, tachycardia, palpitations, hypotension, thrombophlebitis, flushing, dyspnoea, hyperhidrosis, asthenia, injection site reaction, injection site pain, injection site inflammation, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood creatinine phosphokinase increased.  

Inhibitor formation

​​​​​​​PTPs3-6

 

Inhibitor incidence

ReFacto®

1/113 (0.9%)3,4


ReFacto AF®

3/110 (2.7%)5*


Switching from recombinant or plasma-derived factor to ReFacto AF® did not significantly increase the risk of inhibitor formation.6,7  

PUPs2-4  

 

Inhibitor incidence

High-titre (≥5 BU/mL) inhibitors

ReFacto®

32/101 (32%)2-4

16/32 (50%)2-4

Thrombophlebitis1

Thrombophlebitis is an uncommon adverse event (≥0.1% to <1%) with ReFacto AF® use.1

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

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


Abbreviations 
​​​​​​​

PTP, previously treated patient; ​​​​​​​PUP, previously untreated patient.  

*In study 2, low titre FVIII inhibitors (<5 BU/mL) were detected in three subjects; only one case was consistent with development of a de novo inhibitor5
​​​​​​​
References
  1. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Courter S, Bedrosian C. Semin Hematol. 2001;38(2):44–51.  
  3. Lusher J et al. Haemophilia 2003;9:38–49.  
  4. Lusher J, Roth D. Haemophilia 2005;11:292–293.  
  5. Recht M et al. Haemophilia 2009;15(4):869–880.  
  6. Hay C et al. Haemophilia 2015;21(2):219–222.  
  7. Parra Lopez R et al. Thromb Haemost. 2015;114(4):676–684.  
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-0271. September 2021.

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PP-PFE-GBR-3863. November 2021

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