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Adverse event reporting can be found at the bottom of the page
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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.
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®.
ReFacto AF® is effective for:
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*
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†
ReFacto AF® has a well-documented safety profile in patients
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.
For full details on adverse reactions please refer to the Summary of Product Characteristics
Find out more on how to administer and store ReFacto AF using our R2 and FuseNGo devices.
Contact us for more information on ReFacto AF and download our FAQ for supply and stock related queries.
References
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
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
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PP-UNP-GBR-7812. January 2024