MOA
PK & PD Properties
Efficacy
Efficacy Introduction
Risk Reduction Pre-PCI
Myocardial Perfusion
Long-term Risk Reduction Post-PCI
Dosing Administration
Dosing Guidelines & Cockcroft-Gault Equation
Ease of Administration
Bolus Delivery
Infusion Delivery
Dosing Compatibilities
Safety
Major Bleeding in PCI
Minor Bleeding in PCI
Bleeding Rates in PROTECT
Bleeding in Renally Impaired Patients
Clinical Studies Database
PURSUIT
ESPRIT
PROTECT
CLEAR PLATELETS
Clear Platelets Introduction
Platelet Aggregation Inhibition
Reduction of Troponin-I Release
Full Prescribing Information
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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

ACC/AHA Guidelines recommend use of GP IIb-IIIa inhibitors for treatment of unstable angina or non–ST–segment elevation myocardial infarction (UA/NSTEMI), as well as in patients undergoing percutaneous coronary intervention (PCI).1,3 Over 1.4 million people in the US have UA/NSTEMI and more than 1,000,000 undergo PCI annually.3,4

How INTEGRILIN® Works

INTEGRILIN® prevents the aggregation of blood platelets that, when allowed to form a thrombus, can obstruct blood flow through the coronary arteries.1,4 INTEGRILIN® can be administered upon diagnosis, including in the emergency room setting, regardless of whether the patient ultimately undergoes PCI or drug therapy alone.1

Treatment with INTEGRILIN® has been shown to decrease the rate of a combined endpoint of death or new MI in patients with UA/NSTEMI and the composite of death, MI, or urgent target vessel revascularization in patients undergoing PCI.5–7

 

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

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.
  • 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.
  • The CRUSADE Executive Committee. A Practical Guide to Understanding the 2002 ACC/AHA Guidelines for the Management of Patients With Non–ST-Segment Elevation Acute Coronary Syndromes. Durham, NC: Duke Clinical Research Institute; 2002.
  • 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.
  • INTEGRILIN® (eptifibatide) [prescribing information]. Kenilworth, NJ: Schering Corporation; 2005.
  • 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 is a registered trademark of Millennium Pharmaceuticals, Inc.
Schering Plough
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