ide 180/2.0/180
(n=1040) Hazard Ratio
(95% CI)
Percentages are Kaplan-Meier event rates.
Death, MI, or Target Vessel Revascularization
6 Months 187 (18.5%) 146 (14.3%) 0.744 (0.599, 0.924)
1 Year 222 (22.1%) 178 (17.5%) 0.762 (0.626, 0.929)
Death, MI
6 Months 117 (11.5%) 77 (7.4%) 0.631 (0.473, 0.841)
1 Year 126 (12.4%) 83 (8.0%) 0.630 (0.478, 0.832)
INDICATIONS AND USAGE
INTEGRILIN is indicated:
For the treatment of patients with acute coronary syndrome (unstable angina/non-ST- segment elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction.
For the treatment of patients undergoing PCI, including those undergoing intracoronary stenting. In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention.
In the IMPACT II, PURSUIT, and ESPRIT studies of eptifibatide, most patients received heparin and aspirin (see CLINICAL STUDIES).
CONTRAINDICATIONS
Treatment with eptifibatide is contraindicated in patients with:
A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days.
Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy.
Major surgery within the preceding 6 weeks.
History of stroke within 30 days or any history of hemorrhagic stroke.
Current or planned administration of another parenteral GP IIb/IIIa inhibitor.
Dependency on renal dialysis. (See WARNINGS, Renal Insufficiency.)
Known hypersensitivity to any component of the product.
WARNINGS
Bleeding
Bleeding is the most common complication encountered during eptifibatide therapy. Administration of eptifibatide is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group (TIMI) (see ADVERSE REACTIONS). Most major bleeding associated with eptifibatide has been at the arterial access site for cardiac catheterization or from the gastrointestinal or genitourinary tract.
In patients undergoing percutaneous coronary interventions, patients receiving eptifibatide experience an increased incidence of major bleeding compared to those receiving placebo without a significant increase in transfusion requirement. Special care should be employed to minimize the risk of bleeding among these patients (see PRECAUTIONS). If bleeding cannot be controlled with pressure, infusion of eptifibatide and concomitant heparin should be stopped immediately.
Renal Insufficiency
Approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. Total drug clearance is decreased by approximately 50% and steady-state plasma eptifibatide concentrations are doubled in patients with an estimated creatinine clearance <50 mL/min (using the Cockcroft-Gault equation). Therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients (see DOSAGE AND ADMINISTRATION). The safety and efficacy of eptifibatide in patients dependent on dialysis has not been established.
Thrombocytopenia
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