Addition of INTEGRILIN(R) (Eptifibatide) to Bivalirudin Plus Standard of Care Inhibits Platelet Aggregation in Patients Undergoing Elective Coronar...(mplication encountered duringINTEGRILIN(...),Health

Date:11/5/2007

mplication encountered during INTEGRILIN(R) therapy. The majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal and retroperitoneal bleeding were also seen more commonly with INTEGRILIN(R) compared to placebo; INTEGRILIN(R) 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(R) and concomitant heparin should be stopped immediately; because INTEGRILIN(R) inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostatic, including thrombolytics, oral anticoagulants, NSAIDs, and dipyridamole; use with other GP IIb-IIIa inhibitors should be avoided; INTEGRILIN(R) is cleared in part by the kidney and its plasma concentrations are doubled in patients with renal disease (CrCl <50 mL/min); therefore, the infusion dose of INTEGRILIN(R) needs to be reduced to 1mcg/kg/min in these patients; INTEGRILIN(R) is contraindicated in patients who are dependent upon renal dialysis (please see dosing guidelines); caution should be exercised when administering INTEGRILIN(R) to patients with a platelet count <100,000/mm3.

Full prescribing information for INTEGRILIN(R) is available at http://www.integrilin.com.

About Schering-Plough

Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 33,500 people around the world. Th
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