PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Possia - ticagrelor?
Possia is a medicine that contains the active substance ticagrelor. It is available as round yellow tablets (90 mg).
What is Possia used for - ticagrelor?
Possia is used in combination with aspirin to prevent atherothrombotic events (problems caused by blood clots and arterial stiffness), such as myocardial infarction or stroke. It is administered in adult patients with previous myocardial infarction or with unstable angina (a type of chest pain caused by problems with the blood supply to the heart).
The medicine can only be obtained with a prescription.
How is Possia - ticagrelor used?
The starting dose of Possia is two tablets taken at the same time, followed by a regular dose of one tablet twice a day. Patients should also take aspirin based on the doctor's indication, except in cases where the doctor himself forbids the patient to be taken for health reasons. Treatment should continue for a maximum period of one year, unless the doctor orders the patient to stop taking the medicine.
How does Possia work - ticagrelor?
The active substance in Possia, ticagrelor, is an inhibitor of platelet aggregation, which means it helps prevent blood clots. When the blood coagulates, this happens due to particular blood cells, the platelets, which adhere to each other (aggregation). Ticagrelor blocks aggregation between platelets by preventing a substance called ADP from binding to a receptor on their surface. In this way, the platelets lose their ability to adhere to each other, thus reducing the risk of clot formation and helping to prevent stroke or myocardial infarction.
What studies have been performed on Possia - ticagrelor?
The effects of Possia were first tested in experimental models before being studied in humans.
In a main study involving over 18, 000 adults with previous myocardial infarction or with unstable angina, Possia was compared with clopidogrel (another platelet aggregation inhibitor). Patients were taking aspirin simultaneously and were treated for up to a year. The main efficacy parameter was the number of patients affected by myocardial reinfarction or stroke or died due to cardiovascular disease.
What benefit has Possia - ticagrelor shown during the studies?
Possia was effective in patients with prior myocardial infarction or unstable angina. In the main study, 9.3% of patients treated with Possia had a myocardial infarction or stroke or died of cardiovascular causes compared to 10.9% of patients treated with clopidogrel.
What are the risks associated with Possia - ticagrelor?
The most common side effects associated with Possia (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal bleeding (bleeding in the stomach or intestines), cutaneous or subcutaneous bleeding, ecchymosis and bleeding at the site of the surgical procedure (at the point where the needle entered the blood vessel). For the full list of all side effects reported with Possia, see the Package Leaflet.
Possia should not be used in patients who may be hypersensitive (allergic) to ticagrelor or any of the other ingredients. It should not be used in patients with moderate to severe liver disease or in patients with ongoing bleeding, or in stroke patients due to intracranial haemorrhage. It must also not be used in patients taking other medicines with a strong blocking effect on one of the liver enzymes (CYP3A4), such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (drugs used in patients with HIV) and nefazodone (used to treat depression).
Why has Possia been approved - ticagrelor?
In the opinion of the Committee for Medicinal Products for Human Use (CHNP), the main study showed that, compared to clopidogrel, Possia reduces the risk of myocardial infarction and death from cardiovascular causes. By contrast, Possia was not more effective than clopidogrel in reducing the risk of stroke.
The CHMP decided that Possia's benefits are greater than its risks and recommended that it be given marketing authorization.
Other information about Possia - ticagrelor
On 03 December 2010, the European Commission granted AstraZeneca a marketing authorization for Possia, valid throughout the European Union. The marketing authorization is valid for five years and is renewable after this period.
For the full version of the EPAR of Possia visit the website of the Agency ema.Europa.eu/Find medicine / Human medicines / European Public Assessment Reports. For more information on treatment with Possia, read the package leaflet (also contained in the EPAR) or consult your doctor or pharmacist.
