What is Integrilin?
Integrilin is a medicine that contains the active substance eptifibatide. Integrilin is available as a solution for infusion (drip into a vein) and solution for injection.
What is Integrilin used for?
Integrilin is used to prevent myocardial infarction (heart attack) in adults. Integrilin is indicated in the following groups:
- patients with unstable angina (a severe form of chest pain of varying intensity);
- patients who have already had a myocardial infarction without Q wave (a type of heart attack) in the presence of chest pain in the last 24 hours and electrocardiogram (ECG) abnormalities or signs of heart problems detected in the blood.
Integrilin is given with aspirin and unfractionated heparin (other drugs that prevent the formation of blood clots).
Patients who are most likely to benefit from Integrilin treatment are those at high risk of myocardial infarction within three to four days of acute (sudden) angina. Patients undergoing percutaneous transluminal coronary angioplasty (ACTP, a type of surgery aimed at cleaning the arteries that feed the heart) are included.
The medicine can only be obtained with a prescription .
How is Integrilin used?
Integrilin should be administered intravenously by a doctor experienced in treating heart problems.
The recommended dosage is a single injection of 180 micrograms per kilogram of body weight to be administered as soon as possible after diagnosis. This injection should be followed by a continuous infusion of 2.0 micrograms / kg per minute for a maximum of 72 hours, until surgery or discharge from the hospital, whichever occurs first.
Patients suffering from moderate kidney problems should be given a reduced dosage during the infusion. Integrilin should not be given to patients with severe kidney problems. When the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure used to unblock restricted coronary arteries), this treatment can be continued for 24 hours after surgery, up to a maximum of 96 hours.
How does Integrilin work?
Integrilin is an inhibitor of platelet aggregation; this means that it helps prevent the formation of blood clots. Blood coagulation occurs by the action of special blood cells, the platelets, which attach to one another (aggregate). The active ingredient of Integrilin, heptafibatide, interrupts platelet aggregation by blocking a protein, glycoprotein IIb / III, located on their surface that helps them to adhere to each other. Integrilin greatly reduces the risk of blood clot formation and helps prevent a new heart attack.
What studies have been carried out on Integrilin?
Integrilin was compared with placebo (a dummy treatment) in a study involving 11, 000 hospitalized patients with signs that briefly indicated a heart attack, or who had already suffered a mild one.
Another study compared Integrilin with placebo in 2, 000 patients who underwent ACTP to remove a blood clot from the coronary arteries and insert a stent (a short tube that remains in the artery and prevents it from closing).
In both studies, other drugs were also given to patients to counteract the formation of blood clots. The main measure of effectiveness of the medicine was the number of patients who had a heart attack or died within 30 days of treatment.
What benefit has Integrilin shown during the studies?
In the first study, Integrilin was more effective than placebo in preventing death or a heart attack within 30 days after its administration. A similar benefit was observed in the second study. The main benefit observed was the reduction in the number of new heart attacks.
What are the risks associated with Integrilin?
The main side effect of Integrilin (seen in more than one in 10 patients) is bleeding, which could be serious. For the full list of all side effects reported with Integrilin, see the Package Leaflet.
Integrilin should not be used in people who may be hypersensitive (allergic) to eptifibatide or any other substance in the medicine. It must not be used in patients who have bleeding problems or who are suffering from a disease that could cause bleeding (eg stroke or severe hypertension), or in patients with severe liver or kidney problems. For the full list of usage restrictions, see the package leaflet.
Why has Integrilin been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that Integrilin's benefits are greater than its risks for the short-term prevention of myocardial infarction. The committee recommended that Integrilin be given marketing authorization.
More information on Integrilin:
On 1 July 1999, the European Commission issued a marketing authorization for Integrilin, valid throughout the European Union. The marketing authorization was renewed on 1 July 2004 and 1 July 2009. The marketing authorization holder is Glaxo Group Ltd.
For the full EPAR for Integrilin, click here.
Last update of this summary: 07-2009.
