ReFacto AF®
(moroctocog alfa)

What is ReFacto AF and what is it used for?

ReFacto AF contains the active substance moroctocog alfa. It is available either in vials or pre-filled syringes.

ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder). It can be used in adults and children, including newborns.

Patients with haemophilia A lack factor VIII (a protein needed for normal clotting of the blood), and as a result, they bleed more readily. They may also have problems, such as bleeding in the joints, muscles and internal organs. Moroctocog alfa, the active substance in ReFacto AF, works in the body in the same way as human factor VIII. It replaces the absent factor VIII, and therefore assists the blood to clot and gives temporary control of bleeding.

After initiation under the supervision of a physician experienced in the treatment of haemophilia A, patients or their carers can give ReFacto AF injections, provided that they have been trained appropriately.

The medicine can only be obtained with a prescription.

 

Reference Information

The European Medicines Agency (EMA) is an agency of the European Union (EU). The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. See what guidance they offer about ReFacto AF.

Medicines in Northern Ireland fall under the remit of the European Medicines Agency (EMA) whilst medicines in Great Britain (England, Scotland and Wales) fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA) following the UK leaving the European Union. These agencies are responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies.

If you would like to see the Summary of Product Characteristics (SPC) or Patient Information Leaflet (PIL) for BESPONSA please follow these links:

 

Great Britain
ReFacto AF® (moroctocog alfa)

Northern Ireland
ReFacto AF® (moroctocog alfa)

 

Pfizer is unable to provide advice on personal medical matters. Please consult your doctor or other relevant health professional for specific, health-related advice and support.

If you get any side effects when taking this or any other medicine, talk to your doctor or other relevant health professional e.g. pharmacist, nurse. This includes any possible side effects not listed in the packaging leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk or search the Google Play or Apple App Store for MHRA Yellow Card. By reporting side effects, you can help provide more information on the safety of this medicine.

PP-REF-GBR-0326 / October 2021