This is a summary of the European public assessment report (EPAR) for ReFacto AF. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ReFacto AF.
- What is ReFacto AF?
ReFacto AF is a powder and solvent that are mixed together to make up a solution for injection. ReFacto AF contains the active substance moroctocog alfa. It is available as vials or prefilled syringes.
- What is ReFacto AF used for?
ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder). ReFacto AF can be used in patients of all ages, including newborns.
The medicine can only be obtained with a prescription.
- How is ReFacto AF used?
ReFacto AF should be started by a doctor who has experience in the treatment of haemophilia A.
ReFacto AF is given by injection into a vein lasting several minutes. The dose and the frequency of treatment depend on whether ReFacto AF is used to treat or prevent bleeding. The dose is adjusted depending on the seriousness of the condition, the extent and location of the bleeding, or the type of surgery. Full details on how to calculate the dose are included in the summary of product characteristics (also part of the EPAR).
Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
- How does ReFacto AF work?
The active substance in ReFacto AF, moroctocog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot). Patients with haemophilia A lack a protein called factor VIII, which causes blood clotting problems, such as bleeding in the joints, muscles and internal organs. ReFacto AF is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
The human coagulation factor VIII in ReFacto AF is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
- How has ReFacto AF been studied?
ReFacto AF was first authorised as ReFacto in April 1999, for use in previously treated and untreated patients with haemophilia A, based on the results of three main studies. In February 2009, a number of changes to the way ReFacto is made were introduced. These included removal of the use of a protein called albumin, which is produced from human blood, from the manufacturing process. The name of the medicine was also changed from ReFacto to ReFacto AF.
Following these changes, the company carried out a study to show that ReFacto and ReFacto AF were treated by the body in the same way. It also carried out two main studies looking at the effectiveness of ReFacto AF: the first looked at the prevention and treatment of bleeding episodes in 94 previously treated patients and the second looked at the prevention of bleeding in 22 patients having surgery.
- What benefit has ReFacto AF shown during the studies?
The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
- What is the risk associated with ReFacto AF?
The most common side effects with ReFacto AF (seen in more than 1 patient in 10) are vomiting and the development of antibodies against factor VIII and against the cells used to produce moroctocog alfa which are present in trace amounts in Refacto AF. When antibodies develop, ReFacto AF will not work effectively, which may result in a loss of bleeding control. For the full list of all side effects reported with ReFacto AF, see the package leaflet.
ReFacto AF must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to any of the other ingredients or to hamster proteins.
- Why has ReFacto AF been approved?
The CHMP noted that ReFacto AF was comparable to ReFacto, the original form of the medicine. Therefore, the Committee decided that ReFacto AF’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- What measures are being taken to ensure the safe use of ReFacto AF?
A risk management plan has been developed to ensure that ReFacto AF is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ReFacto AF, including the appropriate precautions to be followed by healthcare professionals and patients.
- Other information about ReFacto AF
The European Commission granted a marketing authorisation valid throughout the European Union for ReFacto AF on 13 April 1999.
For more information about treatment with ReFacto AF, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 28/09/2015 .
25/08/2015 ReFacto AF -EMEA/H/C/000232 -N/0126
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|ReFacto AF : EPAR - Procedural steps taken and scientific information after authorisation||HR = Hrvatski||22/07/2009||28/09/2015|
|ReFacto AF-H-C-232-P46-FUM-0136 : EPAR - Assessment Report||HR = Hrvatski||29/11/2012|
|ReFacto AF-H-C-232-P46-FUM-0132 : EPAR - Assessment Report||HR = Hrvatski||29/11/2012|
|Refacto AF-H-C-232-II-0059-0068 : EPAR - Assessment Report - Variation||HR = Hrvatski||19/03/2009|
|ReFacto AF : EPAR - Steps taken after authorisation when a cutoff date has been used||HR = Hrvatski||08/09/2006|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|ReFacto AF : EPAR - Procedural steps taken before authorisation||HR = Hrvatski||08/09/2006|
|ReFacto AF : EPAR - Scientific Discussion||HR = Hrvatski||08/09/2006|
This medicine is approved for use in the European Union