ReFacto AF - moroctocog alfa (formerly known as ReFacto)
What is ReFacto AF?
ReFacto AF consists of a powder and a solvent which are mixed together to obtain a solution for injection. ReFacto AF contains the active substance moroctocog alfa.
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 administered to patients of any age, including newborns.
The medicine can only be obtained with a prescription.
How is ReFacto AF used?
ReFacto AF therapy should be initiated by a physician experienced in the treatment of haemophilia A.
ReFacto AF is given by injection into a vein over several minutes. The dose and frequency of the injection vary depending on whether ReFacto AF is used to treat, prevent or reduce bleeding during surgery. The dose should be adjusted to suit depending on the severity and site of the bleeding or the type of surgery. For all information on how to calculate doses, see the package leaflet.
Patients or caregivers can give ReFacto AF injections provided they have received the appropriate instructions.
How does ReFacto AF work?
The active substance in ReFacto AF, moroctocog alfa, is a blood clotting factor protein (a substance that promotes blood clotting). Hemophilia A is characterized by a lack of a protein called factor VIII, which is involved in blood clotting. Factor VIII deficiency causes blood coagulation problems, such as bleeding in the joints, muscles and internal organs. ReFacto AF, used to replace the missing factor VIII makes it possible to remedy the deficiency of factor VIII and to temporarily control bleeding disorders.
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 factor VIII di human coagulation.
How has ReFacto AF been studied?
ReFacto AF was first authorized under the name ReFacto in April 1999, for treatment in previously treated and untreated patients with haemophilia A. This authorization was based on the results of three main studies.
In February 2009, several changes were introduced to the way ReFacto is produced, including eliminating the use of a protein called albumin, which is made from human blood, from the manufacturing process. The drug name was also changed from ReFacto to ReFacto AF.
Following these changes, the pharmaceutical company conducted a study to show that the body assimilates ReFacto and ReFacto AF in the same way. It also conducted two main studies on the effectiveness of ReFacto AF: the first looked at prevention and treatment of bleeding episodes in 94 previously treated patients and the second treatment of bleeding in 22 patients undergoing surgery.
What benefit has ReFacto AF shown during the studies?
Studies have shown that ReFacto AF is 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?
Patients with haemophilia A can develop antibodies (inhibitors) against factor VIII. In these cases, ReFacto AF is not effective and bleeding control may fail. The most common side effect with ReFacto AF (seen in more than 1 in 10 patients) is vomiting. For the full list of side effects reported with ReFacto AF, see the package leaflet.
ReFacto AF must not be used in people who may be hypersensitive (allergic) to human coagulation factor VIII, to any of the other substances or to hamster proteins.
Why has ReFacto AF been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that ReFacto AF is comparable to ReFacto, the original form of the medicine. The CHMP therefore decided that ReFacto AF's benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency). The CHMP recommended the granting of the Marketing Authorization for ReFacto AF.
What measures are being taken to ensure the safe use of ReFacto AF?
In view of the gradual replacement of ReFacto with ReFacto AF on the market, the manufacturer of the drug will provide information packs to healthcare professionals who will prescribe or use ReFacto AF, to all haemophilia patient associations in the European Union (EU), to patients who take ReFacto AF and laboratories that will monitor patients treated with ReFacto AF. These packages will include information on the differences between ReFacto and ReFacto AF, on the safe use of ReFacto AF, on how to report side effects, information on similar medicines available outside of the EU, and finally reminds the patient to bring enough ReFacto AF with them in case of travel.
Other information about ReFacto AF:
On 13 April 1999, the European Commission issued a "Marketing Authorization" for ReFacto, valid throughout the European Union. The holder of the "Marketing Authorization" for the medicinal product is Wyeth Europa Ltd. The authorization the marketing was renewed on 13 April 2004 and 13 April 2009. On 18 December 2008 the name of the medicine was changed to ReFacto AF.
For the full version of the ReFacto AF EPAR click here.
Last update of this summary: 04-2009.
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