Active Substance: moroctocog alfa
Common Name: moroctocog alfa
ATC Code: B02BD02
Marketing Authorisation Holder: Pfizer Ltd.
Active Substance: moroctocog alfa
Authorisation Date: 1999-04-13
Therapeutic Area: Hemophilia A
Pharmacotherapeutic Group: Antihaemorrhagics
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.
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 injection depend on whether ReFacto AF is used to treat or prevent bleeding, or to reduce bleeding during surgery. The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery. Full details on how to calculate the dose are included in the package leaflet.
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 is involved in blood clotting. The lack of factor VIII causes blood clotting problems, such as bleeding in the joints, muscles and internal organs. ReFacto AF is used to replace the missing factor VIII. It corrects the factor-VIII deficiency and gives temporary control of the bleeding disorder.
Moroctocog alfa 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?
Haemophilia A patients may develop antibodies (inhibitors) to factor VIII. If this happens, ReFacto AF will not work effectively, which may result in a loss of bleeding control. The most common side effect with ReFacto AF (seen in more than 1 patient in 10) is vomiting. For the full list of all side effects reported with ReFacto AF, see the package leaflet.
ReFacto AF should not be used in people who may be 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?
The company that makes the medicine will provide educational packs for healthcare workers who will prescribe or use ReFacto AF, for all associations of haemophilia patients in the European Union (EU), for patients receiving ReFacto AF and for laboratories that will monitor such patients. These packs will include information on the differences between the vial product and the prefilled syringe, how to use ReFacto AF safely, how to report side effects, information on similar medicines available outside the EU, and a reminder that patients should carry enough ReFacto AF with them if they are travelling.
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.
Source: European Medicines Agency
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