INTEGRILIN Solution for infusion Ref.[8874] Active ingredients: Eptifibatide

This product is for hospital use only. It should be administered by specialist physicians experienced in the management of acute coronary syndromes.

INTEGRILIN solution for infusion must be used in conjunction with INTEGRILIN solution for injection.

Concurrent administration of heparin is recommended unless this is contraindicated for reasons such as a history of thrombocytopenia associated with use of heparin (see ‘Heparin administration’, section 4.4). INTEGRILIN is also intended for concurrent use with acetylsalicylic acid, as it is part of standard management of patients with acute coronary syndromes, unless its use is contraindicated.

Posology

Adults (≥18 years of age) presenting with unstable angina (UA) or non-Q-wave myocardial infarction (NQMI)

The recommended dosage is an intravenous bolus of 180 microgram/kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2 microgram/kg/min for up to 72 hours, until initiation of coronary artery bypass graft (CABG) surgery, or until discharge from the hospital (whichever occurs first). If Percutaneous Coronary Intervention (PCI) is performed during eptifibatide therapy, continue the infusion for 20-24 hours post-PCI for an overall maximum duration of therapy of 96 hours.

Emergency or semi-elective surgery

If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately. If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.

Hepatic impairment

Experience in patients with hepatic impairment is very limited. Administer with caution to patients with hepatic impairment in whom coagulation could be affected (see section 4.3, prothrombin time). It is contraindicated in patients with clinically significant hepatic impairment.

Renal impairment

In patients with moderate renal impairment (creatinine clearance ≥30 - <50 ml/min), an intravenous bolus of 180 microgram/kg should be administered followed by a continuous infusion dose of 1.0 microgram/kg/min for the duration of therapy. This recommendation is based on pharmacodynamic and pharmacokinetic data. The available clinical evidence cannot however confirm that this dose modification results in a preserved benefit (see section 5.1). Use in patients with more severe renal impairment is contraindicated (see section 4.3).

Paediatric population

It is not recommended for use in children and adolescents below 18 years of age, due to a lack of data on safety and efficacy.

The experience in humans with overdose of eptifibatide is extremely limited. There was no indication of severe adverse reactions associated with administration of accidental large bolus doses, rapid infusion reported as overdose or large cumulative doses. In the PURSUIT trial, there were 9 patients who received bolus and/or infusion doses more than double the recommended dose, or who were identified by the investigator as having received an overdose. There was no excessive bleeding in any of these patients, although one patient undergoing CABG surgery was reported as having had a moderate bleed. Specifically, no patients experienced an intracranial bleed.

Potentially, an overdose of eptifibatide could result in bleeding. Because of its short half-life and rapid clearance, the activity of eptifibatide may be halted readily by discontinuing the infusion. Thus, although eptifibatide can be dialysed, the need for dialysis is unlikely.

3 years.

Store in a refrigerator (2°C-8°C).

Store in the original package in order to protect from light.

One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.

Physical and chemical compatibility testing indicate that INTEGRILIN may be administered through an intravenous line with atropine sulfate, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, tissue plasminogen activator, or verapamil. INTEGRILIN is compatible with 0.9% sodium chloride solution for infusion and with dextrose 5% in Normosol R with or without potassium chloride. Please refer to the Normosol R Summary of Product Characteristics for details on its composition.

Before using, inspect the vial contents. Do not use if particulate matter or discolouration is present. Protection of INTEGRILIN solution from light is not necessary during administration.

Discard any unused medicinal product after opening.