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U.S. Department of Health and Human Services

Safety

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Revlimid (lenalidomide) Capsules February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

Sections Modified

PRECAUTIONS

  • Renal Impairment
    • Since lenalidomide is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID (lenalidomide) are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. See DOSAGE AND