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.
INTEGRILIN is a registered trademark of Millennium Pharmaceuticals, Inc.
Copyright © 2007, Schering Corporation, Kenilworth, NJ 07033
All rights reserved. ITW0007 01/07
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