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U.S. Department of Health and Human Services

Safety

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Lovenox (enoxaparin sodium injection)

Audience: Physicians, pharmacists, and other healthcare providers

FDA and Aventis Pharmaceuticals revised the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of labeling, describing the need for a dosage adjustment for patients with severe renal impairment (creatinine clearance <30mL/min) who have increased exposure to enoxaparin. No specific dosage adjustment is required in patients with mild or moderate renal impairment and in low-weight patients. However, low-weight patients should be observed carefully for signs and symptoms of bleeding.

[March 2004 - Letter - Aventis]
[July 2004 - Label - Aventis]