Label Changes for:
Entereg (alvimopan) capsules
November 2009
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009
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.
