Risk Evaluation and Mitigation Strategies (REMS) Summary

Goals of the LOTRONEX (alosetron hydrochloride) Tablets and Authorized Generic (alosetron hydrochloride) Tablets REMS Program

The goals and objectives of the LOTRONEX REMS are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with LOTRONEX and its authorized generic alosetron hydrochloride by:

• Informing prescribers of LOTRONEX/alosetron hydrochloride about:
- the serious risks of IC and serious CoC associated with LOTRONEX/alosetron hydrochloride
- the importance of understanding that LOTRONEX/alosetron hydrochloride should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks
- the importance of counseling patients about the risks of IC and serious CoC

• Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms