EPTIFIBATIDE

What it is

Eptifibatide Medsurge is a solution for injection containing eptifibatide as the active ingredient. The medicine is formulated in two dosage administration forms: a bolus injection in a single dose 10 mL vial containing eptifibatide 20 mg (2 mg/mL), and a solution for intravenous infusion in a single dose 100 mL vial containing eptifibatide 75 mg (0.75 mg/mL). Eptifibatide belongs to the class of RGD-mimetics and binds to the platelet receptor glycoprotein (GP) IIb-IIIa, reversibly inhibiting platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to GP IIb-IIIa.

Approved indications

— Patients undergoing nonurgent percutaneous coronary intervention with intracoronary stenting. — Treatment of patients with unstable angina or non-Q-wave myocardial infarction.

Dosing overview

Eptifibatide Medsurge is for hospital use only, by specialist physicians experienced in the management of acute coronary syndromes or PCI.

Key safety warnings

Eptifibatide is an antithrombotic agent that acts by inhibition of platelet aggregation. Women, the elderly and patients with low body weight appear to have an increased risk of bleeding and must be monitored closely with regard to bleeding. The risk of bleeding is most common at the arterial access site in patients undergoing percutaneous arterial procedures. All potential bleeding sites including catheter insertion sites, arterial, venous or needle puncture sites, cutdown sites, gastrointestinal, genitourinary and retroperitoneal sites, and central and peripheral nervous system should be observed carefully. During the marketing of eptifibatide infusion, very rare cases of fatal bleeding have been reported. During treatment with eptifibatide there is a significant increase in bleeding rates from arterial puncture sites. If an arterial procedure is required during therapy, care must be taken to ensure that only the anterior wall of the femoral artery is punctured. If an arterial sheath is used, it should be removed only after coagulation has returned to normal. After removal of the sheath, careful haemostasis must be ensured under close observation for at least 4 hours. Since either repeat exposure with any GP IIb-IIIa ligand-mimetic agent or first-time exposure to a GP IIb-IIIa inhibitor may be associated with immune-mediated thrombocytopenic responses, care should be exercised to observe for possible thrombocytopenia associated with hypotension and/or other signs of hypersensitivity. Administration of eptifibatide by intravenous bolus and infusion causes up to a 5-fold increase in bleeding time. This increase is readily reversible upon discontinuation of the infusion with bleeding times returning towards baseline in approximately 6 hours.

Contraindications

Eptifibatide Medsurge must not be used to treat patients with evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding (except menstrual bleeding) within the previous 30 days of treatment; history of stroke within 30 days or any history of haemorrhagic stroke; known history of intracranial disease (neoplasm, arteriovenous malformation, aneurysm); major surgery or severe trauma within past 6 weeks; a history of bleeding diathesis; thrombocytopenia (<100 × 10⁹/L); prothrombin time >1.2 times control or International Normalised Ratio (INR) ≥ 2.0; severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg on antihypertensive therapy); dependency on renal dialysis; clinically significant hepatic impairment; concomitant or planned administration of a thrombolytic agent; concomitant or planned administration of another parenteral GP IIb-IIIa inhibitor; or hypersensitivity to the active substance or to any of the excipients.

Regulatory history

Eptifibatide Medsurge was first listed on the Australian Register of Therapeutic Goods on 20 June 2025.