LOTRONEX REMS (Risk Evaluation and Mitigation Strategy) Program
LOTRONEX and its authorized generic alosetron hydrochloride are available by prescription as:
LOTRONEX® (alosetron hydrochloride) Tablets.
What is the LOTRONEX REMS Program?
A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure the benefits of a drug outweigh the risks. The purpose of the LOTRONEX REMS Program is to inform prescribers about the risks of:
Serious Gastrointestinal Adverse Reactions, including ischemic colitis and serious complications of constipation, which have resulted in hospitalization and, rarely, blood transfusion, surgery, and death.
Click below for complete prescribing information, including Boxed Warning and Medication Guide: