Eptifibatide Accord

What is Eptifibatide Accord and what is it used for?

Eptifibatide Accord is a medicine used to prevent a heart attack in adults. It is indicated in the following groups:

patients with unstable angina (chest pain caused by insufficient blood flow to the heart, which can arise at rest or without apparent cause);
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.

Eptifibatide Accord is given with aspirin and unfractionated heparin (other drugs that prevent the formation of blood clots).

Patients who are most likely to benefit from Eptifibatide Accord therapy are those at high risk of heart attack, during the three to four days following the onset of acute (sudden) angina. Patients undergoing percutaneous transluminal coronary angioplasty (ACTP, a type of intervention aimed at clearing the arteries that feed the heart) are included.

The drug contains the active substance eptifibatide.

Eptifibatide Accord is a "generic medicine". This means that Eptifibatide Accord is similar to a "reference medicine" already authorized in the European Union (EU) called Integrilin. For more information on generic medicines, see the questions and answers by clicking here.

How is Eptifibatide Accord used?

Eptifibatide Accord should be given by a doctor who has experience in managing heart attacks and angina and can only be obtained with a prescription. It is available as a solution for infusion (drip into a vein) and intravenous injection.

The recommended dose is 180 micrograms per kilogram of body weight, administered by intravenous injection 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. When the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure used to unblock the narrow coronary arteries), the infusion of Eptifibatide Accord can be continued for a maximum of 24 hours after surgery, up to maximum 96 hours of treatment.

Patients with moderate renal impairment should be given a reduced dose during the infusion. Eptifibatide Accord should not be used in patients with severe kidney problems.

How does Eptifibatide Accord work?

Eptifibatide Accord is an inhibitor of platelet aggregation. This means that it helps to prevent blood cells called platelets from sticking together (aggregation). This aggregation of platelets is an important phase in the formation of a blood clot and, if it occurs in the blood vessels supplying the heart, can cause a heart attack. The active ingredient in Eptifibatide Accord, eptifibatide, interrupts platelet aggregation by blocking a protein, glycoprotein IIb / III, located on their surface that helps them stick together. This reduces the risk of blood clots forming and helps prevent heart attacks.

How has Eptifibatide Accord been studied?

The company presented data on eptifibatide from the scientific literature. No further studies were needed as Eptifibatide Accord is a generic medicine given by injection and infusion into a vein and contains the same active substance as the reference medicine, Integrilin.

What are the benefits and risks of Eptifibatide Accord?

Because Eptifibatide Accord is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.

Why has Eptifibatide Accord been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Eptifibatide Accord has been shown to be comparable to Integrilin. Therefore, the CHMP considered that, as in the case of Integrilin, the benefits outweigh the identified risks. The committee recommended approving the use of Eptifibatide Accord in the EU.

What measures are being taken to ensure the safe and effective use of Eptifibatide Accord?

A risk management plan has been developed to ensure that Eptifibatide Accord 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 Eptifibatide Accord, including the appropriate precautions to be followed by healthcare professionals and patients.