WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
Infrequent but serious gastrointestinal adverse reactions 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.
The Prescribing Program for LOTRONEX was implemented to help reduce risks of serious gastrointestinal adverse reactions. Only prescribers who have enrolled in the Prometheus Prescribing Program for LOTRONEX, based on their understanding of the benefits and risks, should prescribe LOTRONEX
[see Warnings and Precautions ].
LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy
[see Indications and Usage (1)]
. Before receiving the initial prescription for LOTRONEX, the patient must read and sign the Patient Acknowledgement Form for LOTRONEX
[see Patient Counseling Information ].
LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. Patients should immediately report constipation or symptoms of ischemic colitis to their prescriber. LOTRONEX should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their prescriber if the constipation does not resolve after LOTRONEX is discontinued. Patients with resolved constipation should resume LOTRONEX only on the advice of their treating prescriber [see Dosage and Administration (2.1), Warnings and Precautions (5.1), (5.2)].
The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type.
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 reactions 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.
Published Studies Related to Lotronex (Alosetron)
A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg alosetron in women with severe diarrhea-predominant IBS. [2007.08]
OBJECTIVE: Alosetron is indicated for women with chronic, severe diarrhea-predominant IBS (d-IBS) who have not responded adequately to conventional therapy. Constipation is the most common adverse event with alosetron treatment. Multiple dosing regimens were assessed in a randomized, double-blind, placebo-controlled study (S3B30040) to determine efficacy, tolerability, and evaluate constipation rate... CONCLUSION: Alosetron 0.5 mg and 1 mg once daily as well as 1 mg twice daily are effective in providing global improvement in IBS symptoms, adequate relief of IBS pain and discomfort, and improvement in bowel symptoms in women with severe d-IBS. Lower dosing regimens resulted in a decreased constipation rate.
The effects of the 5-HT3 antagonist, alosetron, on brain serotonin synthesis in patients with irritable bowel syndrome. [2005.04]
Serotonin (5-HT) plays an important role in the pathophysiology of irritable bowel syndrome (IBS). Using alpha-[(11)C]methyl-L-tryptophan-positron emission tomography (PET), it was demonstrated that brain 5-HT synthesis is increased in patients with IBS, in a gender-specific manner...
A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS. [2005.01]
BACKGROUND: A randomized, double blind, placebo-controlled dose-ranging study was conducted to assess the efficacy of alosetron in men with diarrhea-predominant irritable bowel syndrome (IBS)... CONCLUSIONS: Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS.
Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome. [2004.11]
OBJECTIVES: To assess long-term safety and efficacy of alosetron in women with severe, chronic diarrhea-predominant IBS and in a subset having more frequent urgency (i.e., bowel urgency at least 10 of 14 days during screening)... CONCLUSIONS: Long-term use of alosetron is effective and well-tolerated in women with chronic, diarrhea-predominant IBS, including those with more frequent urgency.
Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials. [2004.08]
BACKGROUND & AIMS: The aim of this study was to assess the effect of alosetron on bowel urgency and irritable bowel syndrome (IBS) global improvement in diarrhea-predominant IBS (D-IBS)... CONCLUSIONS: Alosetron effectively manages bowel urgency and improves global symptoms in women with severe chronic D-IBS.
Clinical Trials Related to Lotronex (Alosetron)
Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS) [Completed]
This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in
Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and
(ii) to obtain reference data for endpoints and dosage and administration of a next phase
Study to Assess the Effect Of Alosetron On Mucosal Blood Flow [Completed]
This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs
placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
LOTRONEX´┐Ż in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) [Completed]
An observational study to evaluate LOTRONEX« in women with severe IBS-D in the current
clinical practice setting.
Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy [Completed]
The purpose of this study is to compare the safety and effectiveness of as needed versus
fixed dosing of an investigational medication for women with severe diarrhea-predominant
Irritable Bowel Syndrome (IBS) who have failed conventional therapy.
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy [Completed]
The purpose of this study is to compare the safety and effectiveness of different doses of
an investigational medication in women with severe diarrhea-predominant Irritable Bowel
Syndrome (IBS) who have failed conventional therapy.
Reports of Suspected Lotronex (Alosetron) Side Effects
Colitis Ischaemic (12),
Abdominal Pain (2),
Rectal Haemorrhage (2),
Hepatic Failure (2),
Condition Aggravated (2),
Ischaemic Cardiomyopathy (1),
Enterococcal Infection (1),
Abortion Spontaneous (1),
Constipation (1), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Lotronex has an overall score of 9. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
Lotronex review by 50 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || irritable bowel syndrom|
|Dosage & duration:|| || 1 mg taken twice daily for the period of 8 years +|
|Other conditions:|| || high cholesterol|
|Other drugs taken:|| || dicyclomene HCL, Lipitor|
|Benefits:|| || Lotronex used to control diarrhea due to chronic irritable bowel syndrome. Thuogh clinical studies were only completed on women I have found the medication to be highly effective with few side effects|
|Side effects:|| || occasional constipation which goes away by skipping the medecine for a day|
|Comments:|| || one milligram twice a day (morning and evening)|
Page last updated: 2007-10-19