EPAR summary for the public
What is Revasc?
Revasc is a powder and solvent in a vial, which is made up i to a solution for injection. Revasc contains the active substance desirudin.
tummy). A doctor whoproducthas experience in coagulation (clotting) disorders should start treatment with Revasc. The recommended dose of Revasc is 15 mg twice daily. The first injection should be started 5
to 15 minutes before su ge y but after any anaesthesia. Revasc is then given twice daily for 9 and up to a maximum of 12 days, or until the patient is able to walk, whichever occurs first. In patients who have liver or kidney roblems, the doctor will monitor blood clotting to see if the dosages may need to
MedicinalHow does Rev sc work?
Blood clott g can be a problem when blood flow is disturbed in any way. Revasc is an anticoagulant; it prevents the blood from coagulating (clotting). Desirudin, the active substance in Revasc, is nearly ident al to hirudin, the anticoagulant substance produced by leeches. Desirudin is produced by a method known as ’recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce the substance. It specifically blocks one of the substances involved in the clotting process, thrombin. Thrombin is central to the complete process of blood clotting. By using Revasc during and after hip or knee surgery, the risk of a blood clot forming in the blood vessels of the legs (deep vein thrombosis) is greatly reduced.
How has Revasc been studied?
The effectiveness of Revasc as an anticoagulant has been studied in four studies involving 1,621 patients who received Revasc. Revasc was compared with unfractionated heparin or enoxaparin (other anticoagulants). The main measures were the overall rate of thrombotic events (blood clots causing
problems) and the rate of deep vein thrombosis (the formation of a blood clot in one of the deep veins of the body, usually in the leg).
What benefit has Revasc shown during the studies?
The studies showed that desirudin was more effective than both comparator medicines in the prevention of deep vein thrombosis after hip replacement surgery.
What is the risk associated with Revasc?
The most common side effects with Revasc (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), nausea (feeling sick), wound secretion (oozing of fluid from wounds), hypotension (low blood pressure), deep thrombophlebitis (inflammation of deep veins that can be caused by a blood clot), fever, injection site mass (lumps at the site of injection), haematomas (collections of blood), oedema (swelling) in legs, and
Revasc should not be used in people who may be hypersensitive (allergic) to desir din or any of the other ingredients, who are pregnant, who have had recent bleeding, who have severe high blood pressure or severe liver or kidney problems, or who have a heart infection. For the full list of
Why has Revasc been approved?
The Committee for Medicinal products for Human Use (CHMP)longerdecided that Revasc’s benefits are
greater than its risks to prevent deep vein thrombosis in patie ts u dergoing hip or knee replacement. The Committee recommended that Revasc be given marketi g authorisation.