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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

Flexible dosing

No two days are the same. No two patients are the same. ReFacto AF® offers frequent, flexible dosing so your patients are covered for everyday life.1-3

ReFacto AF® can be administered as on-demand or prophylactic treatment.1

Prophylaxis

For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20–40 IU of factor VIII per kg body weight at intervals of 2–3 days.1

In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.1

​​​​​​​In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma levels (in percentage of normal or in IU/dL) in the corresponding period.1

The following table can be used to guide dosing in bleeding episodes and surgery:  

Degree of haemorrhage/Type of surgical procedure

Factor VIII level required (%) or (IU/dL)

Frequency of doses (hours) / Duration of therapy (days)

​​​​​​​Haemorrhage

 

 

​​​​​​​Early haemarthrosis, muscle bleeding or oral bleeding

20–40

Repeat every 12–24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.

More extensive haemarthrosis, muscle bleeding or haematoma 

30–60

Repeat infusion every 12-24 hours for 3–4 days or more until pain and acute disability are resolved.

Life-threatening haemorrhage

60–100

Repeat infusion every 8–24 hours until threat is resolved.

Surgery

 

 

Minor surgery including tooth extraction

30–60

Every 24 hours, at least 1 day, until healing is achieved.

Major surgery

80–100 (pre- and post- operative)

Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).

Adapted from ReFacto AF® (moroctocog alfa) Summary of Product Characteristics.1

On-demand treatment

ReFacto AF® is available in a wide range of colour-coded doses.

ReFacto AF® powder and solvent for solution for injection is available in 250 IU, 500 IU, 1000 IU, 2000 IU.1

ReFacto AF® powder and solvent for solution for injection in a pre-filled syringe is available in 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU.1

Dose optimisation with ReFacto AF®

Patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.1,2

Shorter dose intervals or higher doses may be necessary to deliver adequate coverage based on the patient’s bleeding phenotype, levels of physical activity, and preference regarding convenience and adherence.1–3  

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Administration and storage

ReFacto AF® is administered in the FuseNGo device, which allows all-in-one reconstitution of factor VIII.1

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Patient satisfaction with the FuseNGo

ReFacto AF® (and ReFacto®) have reliably supported you and your patients for over 20 years.1

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Monitoring

The use of the ReFacto AF® Laboratory Standard allows for consistent results regardless of assay type.

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Pfizer support for patients

Pfizer Ltd. is committed to helping patients manage their day-to-day lives.

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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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Contact us

Contact a member of the Pfizer haemophilia team.

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References
  1. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Shapiro AD et al. Haemophilia 2005;11:571–582.
  3. Berntorp E, Andersson N. Semin Thromb Hemost. 2016;42:518–525.  
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-0267. September 2021.

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PP-PFE-GBR-3863. November 2021

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