Lotronex REMS

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:

INDICATION: LOTRONEX/alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome who have: chronic irritable bowel syndrome symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant irritable bowel syndrome is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to irritable bowel syndrome. Because of infrequent but serious gastrointestinal adverse events associated with LOTRONEX/alosetron hydrochloride, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX/alosetron hydrochloride in men.

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This product may be covered by one or more US pending or issued patents.
LOTRONEX is a registered trademark of Prometheus Laboratories Inc., San Diego, CA