INTEGRILIN® (eptifibatide) Injection

INTEGRILIN^® is an antithrombotic agent that reversibly inhibits platelet aggregation by preventing binding of fibrinogen to the GP IIb-IIIa receptor. INTEGRILIN^® helps prevent occlusion of the coronary arteries, thus reducing the incidence of ischemic events.^1,2

SIGNIFICANT RISK REDUCTION BEFORE, DURING, AND LONG AFTER PCI

PROTECT — Significantly reduces MI pre-PCI³
PERFUSE — Improves perfusion to the myocardium⁴
PRESERVE — Significant event reduction maintained through 1 year⁵
Well-established safety profile^3,4,6

FOR PATIENTS WITH UA/NSTEMI, INTEGRILIN^® IS AN ACC/AHA GUIDELINES IA RECOMMENDATION²

Recommended across a spectrum of risk—including high-risk clinical and/or angiographic features⁷

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)(149KB)

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

References:

Gibler WB, Cannon CP, Blomkalns AL, et al. Practical implementation of the guidelines for unstable angina/non–ST-segment elevation myocardial infarction in the emergency department: a scientific statement from the American Heart Association Council on Clinical Cardiology (Subcommittee on Acute Cardiac Care), Council on Cardiovascular Nursing, and Quality of Care and Outcomes Research Interdisciplinary Working Group, in Collaboration With the Society of Chest Pain Centers. Circulation. 2005;111:2699–2710.
Braunwald E, Antman EM, Beasley JW, et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non–ST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). Available at: http://www.acc.org/qualityandscience/clinical/guidelines/unstable/incorporated/index.htm. Accessed January 11, 2007.
Fintel DJ, Ledley GS. Management of patients with non–ST-segment elevation acute coronary syndromes: insights from the PURSUIT trial. Clin Cardiol. 2000;23(suppl 5):V-1–V-12.
Gibson CM, Cohen DJ, Cohen EA, et al, for the ESPRIT study group. Effect of eptifibatide on coronary flow reserve following coronary stent implantation (an ESPRIT substudy). Am J Cardiol. 2001;87:1293–1295.
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.
INTEGRILIN^® (eptifibatide) [prescribing information]. Kenilworth, NJ: Schering Corporation; 2005.
Smith SC Jr, Feldman TE, Hirshfeld JW Jr, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Available at: http://www.americanheart.org/presenter.jhtml?identifier=3035436. Accessed January 9, 2007.