What is Kengrexal - Cangrelor used for and what is it used for?
Kengrexal is an anticoagulant medicine indicated for reducing the frequency of problems due to blood clots, including myocardial infarction. It is used in combination with aspirin in adult patients with coronary heart disease (heart disease caused by obstruction of the blood vessels supplying the heart), undergoing percutaneous coronary intervention (PCI, a surgical procedure used to dilate narrowed blood vessels that carry blood to the heart). Kengrexal is given to patients who have not been treated before the procedure with other anticoagulant medicines, called "P2Y12 receptor inhibitors" (clopidrogrel, ticagrelor or prasugrel) taken by mouth, and in which therapy with these medicines is not possible or desirable. Kengrexal contains the active ingredient cangrelor.
How is Kengrexal - Cangrelor used?
Kengrexal should be administered by a physician experienced in acute coronary therapy or PCI procedures. The medicine can only be obtained with a prescription and is intended for use only in a hospital setting. Kengrexal is available as a powder to be made up into a solution for injection and infusion (drip) into a vein. Treatment begins with a vein injection at a dose of 30 micrograms per kilogram of body weight, lasting less than one minute, followed immediately by an intravenous infusion of 4 micrograms per kilogram per minute. Treatment should begin before the PCI procedure and the infusion should continue for at least 2 hours or until the end of the procedure, whichever is longer. At the doctor's discretion, the infusion can be continued for a total duration of four hours. At the end of the infusion, patients should be switched to oral maintenance therapy with clopidogrel, ticagrelor or prasugrel.
How does Kengrexal - Cangrelor work?
The active substance in Kengrexal, cangrelor, is an antiplatelet medicine. This means that it helps prevent the aggregation of blood cells called "platelets" and the formation of clots, thus helping to prevent a new myocardial infarction. Cangrelor blocks platelet aggregation by preventing a substance called ADP from binding to their surface. In this way the platelets are less "viscous", which reduces the risk of clot formation.
What benefit has Kengrexal - Cangrelor shown during the studies?
Kengrexal has been compared to clopidogrel taken by mouth in a main study involving over 11, 000 adults with coronary artery disease undergoing PCI. Almost all patients have also taken aspirin and / or other anticoagulant medicines. The main measure of effectiveness was the number of patients reporting an "event", including myocardial infarction or the presence, in vessels supplying the heart, with clots susceptible to intervention, or deceased for any reason within 48 hours after the PCI. Kengrexal has been shown to be more effective than clopidogrel taken orally in reducing the frequency of these events: there was an event or death in 4.7% of patients (257 out of 5 470 subjects) who took Kengrexal compared to 5, 9% (322 of 5 469 subjects) of patients treated with clopidogrel. Kengrexal was also examined in a study in which it was administered before surgery to patients who had previously been treated with anticoagulant medicines taken by mouth. However, the way this study was designed was considered inadequate to demonstrate a clear benefit in these patients, so the company refrained from presenting this use in the authorization application.
What is the risk associated with Kengrexal - Cangrelor?
The most common side effects with Kengrexal (which may affect up to 1 in 10 people) are mild to moderate bleeding and dyspnoea (difficulty breathing). The most serious side effects of Kengrexal include severe and life-threatening bleeding and hypersensitivity (allergic) reactions. For the full list of all side effects reported with Kengrexal, see the package leaflet. Kengrexal should not be used in patients with bleeding in progress or an increased risk of bleeding due to a bleeding disorder, a recent major surgery or a major trauma, or with uncontrolled hypertension. It must not be used in patients who have had a stroke or transient ischemic attack (TIA). For the full list of limitations, see the package leaflet
Why has Kengrexal - Cangrelor been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kengrexal's benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been shown to be effective in reducing problems caused by blood clots in patients undergoing PCI who have not previously received treatment with P2Y12 receptor inhibitors. The fact that the medicine is given into a vein is considered beneficial in patients who cannot swallow and who do not take medicines by mouth. As for the safety profile of Kengrexal, the CHMP noted that the incidence of bleeding is higher for Kengrexal than for clopidogrel. However, this is an expected effect, given the medicinal product's greater efficacy, and counterbalanced by the fact that Kengrexal's activity begins to rapidly diminish once the infusion is stopped.
What measures are being taken to ensure the safe and effective use of Kengrexal - Cangrelor?
A risk management plan has been developed to ensure that Kengrexal 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 Kengrexal, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Kengrexal - Cangrelor
On March 23, 2015, the European Commission issued a marketing authorization for Kengrexal, valid throughout the European Union. For more information on Kengrexal therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015.
