Improvement Maintained Long After PCI

Significant event reductions with INTEGRILIN^® were maintained through 1 year. The primary endpoint of ESPRIT was the composite of death, MI, UTVR, and TBO to open-label eptifibatide due to a thrombotic complication of PCI at 48 hours. The primary endpoint was reduced from 10.5% with placebo to 6.6% (37% reduction) with INTEGRILIN^® (P=0.0015).¹

% Cumulative death or MI through 1 year (ESPRIT)

†	180/2/180=180-mcg/kg IV bolus, followed by a 2-mcg/kg/min infusion, with a second 180-mcg/kg IV bolus 10 minutes after the first bolus.

IMPORTANT PRESCRIBING AND SAFETY CONSIDERATIONS

Indications for INTEGRILIN^® (eptifibatide) Injection:

For the treatment of patients with acute coronary syndrome (UA/NSTEMI), including patients who are
to be managed medically and those undergoing percutaneous coronary intervention (PCI)
For the treatment of patients undergoing percutaneous coronary intervention (PCI), including those
undergoing intracoronary stenting

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 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
Known hypersensitivity to any component of the product

Precautions and Warnings:

In patients undergoing PCI, INTEGRILIN^® (eptifibatide) Injection is associated with an increase in major and minor bleeding at the site of arterial sheath placement. Special care should be employed to minimize the risk of bleeding among these patients
If bleeding cannot be controlled with pressure, infusion of INTEGRILIN^® and concomitant heparin should be stopped immediately
Because INTEGRILIN^® inhibits platelet aggregation, caution should be employed when it is used with drugs that affect hemostasis, including thrombolytics, oral anticoagulants, NSAIDs, and dipyridamole
Use with other GP IIb-IIIa inhibitors should be avoided
INTEGRILIN^® is cleared in part by the kidney and its plasma concentrations are doubled in patients with renal disease (creatinine clearance
<50 mL/min). Therefore, the infusion dose of INTEGRILIN^® needs to be reduced to 1 mcg/kg/min in these patients. INTEGRILIN^® is contraindicated in patients who are dependent upon renal dialysis (please see dosing guidelines)
Caution should be exercised when administering eptifibatide to patients with a platelet count <100,000/mm³
Bleeding is the most common complication encountered during INTEGRILIN^® therapy. The majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal, and retroperitoneal bleeding were seen more commonly with INTEGRILIN^® compared with placebo.

For full Prescribing Information, click here. (PDF)(1.04MB)

About Schering-Plough
Schering Corporation, of Kenilworth, NJ, is a research-based company engaged in the discovery, development, manufacturing, and marketing of pharmaceutical products worldwide. For more information, please visit the company's Web site at www.sch-plough.com.

Contact us at 1-800-222-7579

Reference:

O’Shea JC, Buller CE, Cantor WJ, et al. Long-term efficacy of platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention. JAMA. 2002;287:618–621.