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U.S. Department of Health and Human Services

Safety

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Entereg (alvimopan) capsules

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

 

Summary View

 

USE IN SPECIFIC POPULATIONS

Race
  • No dosage adjustment is necessary in Black, Hispanic and Japanese patients. However, the exposure of ENTEREG in Japanese male healthy volunteers was approximately 2-fold greater than in Caucasian subjects. Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur.
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