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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

How to administer and store ReFacto AF®

ReFacto AF® is administered by intravenous infusion over several minutes after reconstitution of the lyophilised powder for injection with sodium chloride 9 mg/mL (0.9%) solution for injection. The reconstituted product has demonstrated in-use chemical and physical stability for 3 hours at temperatures up to 25°C.1

Reconstitution  

ReFacto AF® can be reconstituted and administered using our R2 or FuseNGo devices.    

We’ve created the ‘ReFacto AF® R2 infusion mat’ and ‘ReFacto AF® FuseNGo infusion mat’ as support materials for your patients. They provide a detailed and visual step-by-step guide on how to use each device.    

In addition, we have also produced an informative leaflet for patients using the FuseNGo device.
​​​​​​​
​​​​​​​Download these materials here, or request printed copies, and any other patient and HCP materials, through the Contact Us page, linked on the right hand side. 

How to store ReFacto AF® kits

  • Store and transport refrigerated (2°C - 8°C).1
  • Do not freeze.1
  • Keep the product in the outer carton to protect it from light.1
  • ReFacto AF® has a shelf life of 3 years.1
  • The product may be removed from refrigerated storage for one single period of maximum 3 months at room temperature (up to 25°C).1
  • ​​​​​​​At the end of this period of room temperature storage, the product must not be returned to refrigerated storage, but is to be used or discarded.1​​​​​​​

After reconstitution:

  • ​​​​​​​Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25°C.1
  • Pre-filled syringes do not contain a preservative.1
  • ​​​​​​​The reconstituted product should be used immediately, or within 3 hours after reconstitution or removal of the grey tip cap.1  

FuseNGo

The dual-chamber FuseNGo device provides a fast and flexible patient experience, with a wide range of doses, and a convenient delivery method.1,2

  • All-in-one reconstitution1
  • Immediate reconstitution1
  • Simple preparation
  • Ease of use

​​​ReFacto AF FuseNGo is available in a range of colour-coded doses (250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU)

A cross-sectional survey was conducted in Austria, Germany, Italy, Spain and the United Kingdom among adults (aged 18–65 years) with haemophilia A who used FVIII product for either prophylaxis or on-demand therapy at least once a month.2

​​​​​​​The survey aimed to identify factors associated with adult patient preferences for different FVIII reconstitution systems and to test ease of use and patient preference for a new dual-chamber syringe.2  

ReFacto AF® FuseNGo is ready in less than one minute (median time; IQR 27 seconds) vs. approximately 4 minutes for other factor VIII reconstitution systems (IQR 285 seconds).2  

Over half (57%) of adult patients preferred ReFacto AF® FuseNGo to their current reconstitution system (n/N = 56/98).2  

Patients indicated that they were significantly more likely (p <0.001 vs. FuseNGo) to use ReFacto AF® FuseNGo prophylactically as well as more often compared to their current reconstitution system.2  

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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.1,3,4

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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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Contact us

Contact a member of the Pfizer haemophilia team.

Contact us

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References
  1. ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland, available here.
  2. Cimino E et al. Patient Prefer Adherence 2014;8:1713–1720.
  3. Shapiro AD et al. Haemophilia 2005;11:571–582.
  4. 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-0266. September 2021.

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*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021

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