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Adverse event reporting can be found at the bottom of the page

Administration and Storage Choosing ReFacto AFChoosing ReFacto AFChoosing ReFacto AFPersonalised dosing 

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Product InformationProduct InformationLaboratory StandardEfficacy & SafetyAdministration & StorageSupport & ResourcesSupport & ResourcesMaterialsVideosOrdering ReFacto AFContact Us

For ReFacto AF® (moroctocog alfa) Prescribing Information for Great Britain and Northern Ireland click here.

Adverse event reporting information can be found at the bottom of the page.

Clinical Efficacy & Safety

​​​​​​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. It does not contain von Willebrand factor, and hence is not indicated in von Willebrand's disease.1

Data supporting the efficacy and safety profile of ReFacto AF®.

Efficacy

ReFacto AF® is effective for:

Repeated prophylaxis exposure

Prophylactic treatment in previously treated patients (PTPs)


 86%  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.2*
 

ReFacto AF® 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.
On-demand treatment and Surgery

Prophylactic treatment in PTPs


 73%  of 10,594 bleeding episodes of all degrees of severity were treated effectively with only 1 infusion (n=113).3
 

On-demand treatment in previously untreated patients (PUPs)


 65%  of 2,589 bleeding episodes were treated effectively with only 1 infusion (n=101).3
 

Surgery 


 99.6%  of the infusions administered either during or after surgery were rated as excellent or good by the surgeon and treating physician (38 patients; 48 surgical procedures; 496 infusions during or after surgery).3†

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.3
Safety1

ReFacto AF® has a well-documented safety profile in patients

  • Thrombophlebitis is an uncommon adverse event (≥0.1% to 1%)1
  • FVIII inhibition in PUPs is a very common adverse event (≥10%);1
  • FVIII inhibition in PTPs is an uncommon adverse event (≥0.1& to <1%)1*

Adverse reactions cited as very common(≥10%): FVIII inhibition (PUPs)*, headaches, arthralgia, cough and pyrexia

Adverse reactions cited as common (≥1% to <10%): decreased appetite, dizziness, haemorrhage, haemotoma, diarrhoea, vomiting, abdominal pain, nausea, urticaria, rash, pruritus, myalgia, chills, catheter site related reaction, antibody test positive, anti-factor VIII antibody test positive.

Frequency is based on studies with all FVIII products which included patients with severe haemophilia A.1

For full details on adverse reactions please refer to the Summary of Product Characteristics

Explore More Laboratory StandardsFind out more about the use of Laboratory Standards and patient satisfaction with the ReFacto AF FuseNGo device. Find out moreLoading

Find out more on how to administer and store ReFacto AF using our R2 and FuseNGo devices.

Administration & StorageFind out moreLoading
Contact Us

Contact us for more information on ReFacto AF and download our FAQ for supply and stock related queries.

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 References 

ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.Parra Lopez R et al. Thromb Haemost. 2015;114(4):676-684Lusher JM et al. Haemophilia 2003;9:38–49.
PP-REF-GBR-0355 July 2023

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 Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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