This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Efient?

Efient is a medicine that contains the active substance prasugrel. It is available as double-arrow-shaped tablets (yellow: 5 mg; beige: 10 mg).

What is Efient used for?

Efient is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention. Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack. Percutaneous coronary intervention is an operation used to unblock narrowed coronary arteries (blood vessels in the heart).

The medicine can only be obtained with a prescription.

How is Efient used?

Efient treatment starts with one 60-mg dose. This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day. The medicine can be taken with or without food. Patients taking Efient should also take aspirin at a dose prescribed by their doctors. It is recommended that treatment with Efient and aspirin continue for up to a year.

The use of Efient in patients below 18 years of age is not recommended because of a lack of information on safety and effectiveness in this age group. Its use is also not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary. In this case, the 5-mg daily dose should be used following a 60-mg starting dose.

How does Efient work?

The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating). Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.

How has Efient been studied?

The effects of Efient were first tested in experimental models before being studied in humans.

In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘maintenance’ doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin. The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention. The main measure of effectiveness was the reduction in the total number of cardiovascular deaths (deaths due to problems in the heart or blood vessels), heart attacks or strokes. The patients were followed up for an average of 14.5 months.

What benefit has Efient shown during the studies?

Efient was more effective than clopidogrel at reducing the total number of cardiovascular deaths, heart attacks or strokes. At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).

What is the risk associated with Efient?

The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising. For the full list of all side effects reported with Efient, see the Package Leaflet.

Efient should not be used in people who may be hypersensitive (allergic) to prasugrel or any of the other ingredients. It must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.

Why has Efient been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Efient’s benefits are greater than its risks, when co-administered with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention. The Committee recommended that Efient be given marketing authorisation.

Which measures are being taken to ensure the safe use of Efient?

The company that makes Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine. The materials will include information on how to prescribe the medicine safely and to remind doctors that the medicine is not recommended for patients over the age of 75 years.

Other information about Efient:

The European Commission granted a marketing authorisation valid throughout the European Union for Efient to Eli Lilly Nederland BV on 25 February 2009.

This EPAR was last updated on 06/06/2011 .

More detail is available in the Summary of Product Characteristics

Product details

Publication details

Product information

20/04/2011  Efient -EMEA/H/C/000984 -II/0006

Contents

• Annex I - Summary of product Characteristics
• Annex IIA - Manufacturing Authorisation Holder responsible for Batch Release
• Annex IIB - Conditions of the Marketing Authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package Leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmaco-therapeutic Group

Antithrombotic agents

Therapeutic Indication

Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
For further information please refer to section 5.1.

Changes since initial authorisation of medicine

Initial Marketing authorisation documents