Identifying Appropriate Patients for LOTRONEX®
LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
- Chronic IBS 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 IBS 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 IBS
Because of infrequent but serious gastrointestinal adverse events associated with LOTRONEX, 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 in men.
PEDIATRIC USE: Safety and effectiveness have not been established in pediatric patients.
- Patients who are elderly, debilitated, or taking additional medications that decrease gastrointestinal motility may be at a greater risk for complications of constipation
- Use with caution in patients with mild or moderate hepatic impairment, as increased exposure to LOTRONEX is likely to occur and may increase the risk of serious adverse events. LOTRONEX should not be used in patients with severe hepatic impairment.
- Insufficient data are available concerning the use of LOTRONEX in patients with renal impairment
IMPORTANT SAFETY INFORMATION: Infrequent but serious gastrointestinal adverse events have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death. Some patients have experienced serious complications of constipation or ischemic colitis without warning. In IBS clinical trials, approximately 10% of patients on LOTRONEX withdrew prematurely because of constipation. The incidence of serious complications of constipation was approximately 0.1% (1 per 1,000 patients) in women receiving either LOTRONEX or placebo. In IBS clinical trials, the cumulative incidence of ischemic colitis in women receiving LOTRONEX was 0.2% (2 per 1,000 patients, 95% confidence interval 1 to 3) through 3 months and was 0.3% (3 per 1,000 patients, 95% confidence interval 1 to 4) through 6 months. Ischemic colitis was not reported in women receiving placebo. The patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patients taking LOTRONEX for longer than 6 months.
LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Patients should immediately report constipation or symptoms of ischemic colitis to their physician. LOTRONEX should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their physician if the constipation does not resolve after LOTRONEX is discontinued. Patients with resolved constipation should resume LOTRONEX only on the advice of their treating physician.
LOTRONEX should not be initiated in IBS patients who are constipated. LOTRONEX is contraindicated in patients with a history of chronic or severe constipation or a history of sequelae from constipation; with a history of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; with a history of ischemic colitis, impaired intestinal circulation, thrombophlebitis, or hypercoagulable state; with current or a history of Crohn's disease or ulcerative colitis; with severe hepatic impairment; with active diverticulitis or a history of diverticulitis; in patients who are unable to understand or comply with the Patient-Physician Agreement; and/or in patients with known hypersensitivity to any component of the product. Concomitant administration of alosetron with fluvoxamine is contraindicated.
Please consult the Complete Prescribing Information.
©2008 Prometheus Laboratories Inc. All rights reserved.