Rapilysin is a vial containing a white powder to be dissolved in a solution for injection. Rapilysin contains the active substance reteplase.
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Rapilysin is used in patients who have had a heart attack (suspected acute myocardial infarction) to help dissolve the blood clots (thrombolysis) that have caused the heart attack. It is given within the 12 hours following the attack.
The medicine can only be obtained with a prescription.
Doctors who are experienced in using medicines that affect blood clotting should be prescribing Rapilysin. Treatment with Rapilysin should be started as soon as possible after the start of heart attack symptoms. Rapilysin is given as two injections, 30 minutes apart. Each injection is given intravenously (into a vein) slowly but within 2 minutes. Rapilysin is given with other medicines that prevent clotting (aspirin, heparin), to stop any reclotting taking place. But Raplilysin and heparin must not be given in the same syringe, as this causes the injection solution to becoming cloudy.
Rapilysin is a thrombolytic (dissolves blood clots). The active substance in Rapilysin, reteplase, is a copy of a natural enzyme, t-PA, but modified to give it faster onset and longer duration of action. It is made by a method known as ?recombinant DNA technology?: it is made by a bacterium that has received a gene (DNA), which makes it able to produce it. Reteplase activates the production of an enzyme, plasmin, that breaks up clots. In myocardial infarction, clots have formed in the arteries to the heart. Rapilysin dissolves the blood clots and helps restore the normal blood flow to the heart.
The effectiveness of Rapilysin has been studied in more than 21,000 patients in 4 studies. Rapilysin has been compared with other medicines used in thrombolysis: streptokinase (6,000 patients) or alteplase (about 15,000 patients). The studies examined the rate of death 35 days after treatment (30 in one study), heart failure, and strokes.
Rapilysin reduced the incidence of heart failure better than streptokinase and was equally effective in reducing death, and as effective as alteplase at preventing death and strokes.
The main side effect of Rapilysin is bleeding (such as a bruise at the site of injection). If bleeding occurs in the brain, this can lead to a stroke, which can be life-threatening. Other less common side effects are chest pains, low blood pressure and shortness of breath. For the full list of all side effects reported with Rapilysin, please see the Package Leaflet.
Rapilysin should not be used in people who may be hypersensitive (allergic) to reteplase or any of the other ingredients, who are at risk of bleeding because of high blood pressure, previous bleeding, etc., who have severe liver or kidney disease or who are taking oral anticoagulants. For the full list of restrictions, see the Package Leaflet.
The Committee for Medicinal Products for Human Use (CHMP) decided that Rapilysin?s benefits are greater than its risks for patients requiring thrombolytic therapy of acute myocardial infarction. They recommended that Rapilysin be given marketing authorisation (made available to doctors).