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Click here for ReFacto AF® (moroctocog alfa) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

ReFacto AF has a favourable safety profile1

Safety profile

The most common adverse reactions reported in pooled clinical trials with 765 subjects2:

  • Factor VIII inhibitors in PUPs, headache, cough, arthralgia and pyrexia – very common (≥10%)
  • Factor VIII inhibitors in PTPs - uncommon (≥ 0.1 to <1%). 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 – common (≥1% to <10%)

Inhibitor formation

PTPs1, 3-6

Inhibitor incidence

De novo inhibitors

ReFacto®

1/113 (0.9%)1,3

0/113 (0%)1,4

ReFacto AF

3/110 (2.7%)5

1/110 (0.9%)5

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

PUPs3, 4

Inhibitor incidence

High-titre (≥5 BU/ml) inhibitors

ReFacto®

32/101 (32%)3, 4

16/32 (50%)3, 4​​​​​​​

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Find out about ReFacto AF efficacy

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Find out about ReFacto AF dosing for On-demand treatment and prophylaxis

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ABR = annualised bleeding rate;
BU = Bethesda units;
PTP = previously treated patient;
​​​​​​​PUP = previously untreated patient.
References
  1. Courter SG and Bedrosian CL. Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients. Semin Hematol 2001;38(2):44–51.
  2. ReFacto AF (moroctocog alfa) Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/6558/smpc
  3. Lusher JM et al. The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia. Haemophilia 2003;9:38–49.
  4. Lusher JM and Roth DA. The safety and efficacy of B-domain deleted recombinant factor VIII concentrates in patients with severe haemophilia A: an update. Haemophilia 2005;11:292–293.
  5. Recht M et al. Clinical evaluation of moroctocog alfa (AF-CC), a new generation of B-domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: demonstration of safety, efficacy, and pharmacokinetic equivalence to full-length recombinant factor VIII. Haemophilia 2009;15(4):869–880.
  6. Hay CR et al. The incidence of factor VIII inhibitors in severe haemophilia A following a major switch from full-length to B-domain-deleted factor VIII: a prospective cohort comparison. Haemophilia 2015;21(2):219–222.
  7. Parra Lopez R et al. Prospective surveillance study of haemophilia A patients switching from moroctocog alfa or other factor VIII products to moroctocog alfa albumin-free cell culture (AF-CC) in usual care settings. Thromb Haemost. 2015;114(4):676–684.
PP-BEN-GBR-0197. March 2021

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Speak to a member of the Pfizer Haemophilia team.

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PP-PFE-GBR-2688. December 2020

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