Patient Information

INFORMATION FOR PATIENTS

I take LOTRONEX or alosetron hydrochloride tablets, what do I need to know about the LOTRONEX REMS Program?

Review the LOTRONEX REMS Program Patient Education Sheet with your Health Care Provider.

Important safety Information about LOTRONEX/alosetron hydrochloride:

Serious bowel (intestine) side effects can happen suddenly including
  • Serious complications of constipation
  • Ischemic colitis (reduced blood flow to the bowel)

These complications may lead to hospital stay, and in rare cases blood transfusions, surgery, or death.
Stop taking LOTRONEX/alosetron hydrochloride and call your doctor right away if you get:

  • Constipated while taking LOTRONEX/alosetron hydrochloride
  • New or worse pain in your stomach area (abdomen)
  • Blood in your bowel movements

Do not start taking LOTRONEX/alosetron hydrochloride again until your doctor tells you to do so.

LOTRONEX/alosetron hydrochloride is:

A medicine only for some women with severe chronic irritable bowel syndrome (IBS) whose main problem is diarrhea and IBS symptoms have not been helped enough by other treatments.

LOTRONEX/alosetron hydrochloride does not cure IBS, and it may not help every person who takes it. For those who are helped, LOTRONEX/alosetron hydrochloride reduces lower stomach area (abdominal) pain and discomfort, the sudden need to have a bowel movement (bowel urgency) and diarrhea from IBS. If you stop taking LOTRONEX/alosetron hydrochloride, your IBS symptoms may return within 1 or 2 weeks to what they were before you started LOTRONEX/alosetron hydrochloride.

Download the:
LOTRONEX REMS Program Patient Education Sheet

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