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Lotronex (Alosetron Hydrochloride) - Summary

 
 



PRESCRIBING PROGRAM FOR LOTRONEX™

PHYSICIAN ENROLLMENT FORM

The Prescribing Program for LOTRONEX was implemented to help reduce risks of serious gastrointestinal adverse events, some fatal, associated with this medicine. The program is intended to help physicians and their patients understand the benefits and risks of treatment with LOTRONEX in order to make fully informed decisions.

I wish to participate in the Prescribing Program for LOTRONEX (PPL) and acknowledge that I have read the complete Prescribing Information for LOTRONEX and understand and will follow the requirements of the PPL described below.

  • For safety reasons, LOTRONEX is approved only for women with severe, diarrhea-predominant irritable bowel syndrome (D-IBS) who have: Chronic IBS symptoms (generally lasting for 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
  • Physicians who enroll in the PPL should be able to diagnose and manage IBS, ischemic colitis, constipation, and complications of constipation, or refer patients to a specialist as needed.
  • Patients considering treatment with LOTRONEX must be educated on the benefits and risks of the drug, given a copy of the Medication Guide, instructed to read it, and encouraged to ask questions. The patient may be educated by the enrolled physician or a healthcare provider under a physician’s direction.
  • After reviewing the Medication Guide prior to the initial prescription, the physician and the patient must both sign the Patient-Physician Agreement form. The original signed form must be placed in the patient’s medical record, and a copy given to the patient.
  • Program stickers must be affixed to all prescriptions for LOTRONEX (i.e., the original and all subsequent prescriptions). Stickers will be provided as part of the Prometheus Prescribing Program for LOTRONEX. Refills are permitted to be written on prescriptions.
  • All prescriptions for LOTRONEX must be written and not transmitted by telephone, facsimile, or computer.
  • Prescribers must report all serious adverse events with LOTRONEX to Prometheus at 1-888-423-5227 or to the Food and Drug Administration at 1-800-FDA-1088.

    ________________________________

    Name of Physician (print)

    ________________________________

    ________________________________

    Signature

     Date

    DEA Number

    ________________________________

    Office Address:

    ________________________________

    ________________________________

    ________________________________

    Office Phone Number:

    ________________________________

    Office Fax Number:

    ________________________________

  • Upon enrollment, you will receive a prescribing kit for LOTRONEX with the complete Prescribing Information, Prescribing Program for LOTRONEX stickers, multiple copies of the Medication Guide and Patient-Physician Agreement for LOTRONEX, and instructions for ordering additional supplies of Program materials.

    You only need to enroll once, and you are under no obligation to prescribe LOTRONEX.

    If you have any questions, please call the Prescribing Program for LOTRONEX at 1-888-423-5227 or visit www.lotronex.com.

    TO ENROLL, VISIT WWW.LOTRONEX.COM OR PHONE 1-888-423-5227 OR COMPLETE THIS FORM IN ITS ENTIRETY AND MAIL OR FAX TO THE FOLLOWING ADDRESS:

    Prescribing Program for Lotronex

    9410 Carroll Park Drive
    San Diego, CA 92121
    1-888-423-5227
    Fax Number: 1-858-824-0896

    Prometheus®
    Therapeutics & Diagnostics

    For the person in every patient

    ©2007 Prometheus Laboratories Inc. All rights reserved LX001A08
    January 2008

    WARNING

    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.

    • The Prescribing Program for LOTRONEX™ was implemented to help reduce risks of serious gastrointestinal adverse events. Only physicians who have enrolled in Prometheus' Prescribing Program for LOTRONEX, based on their understanding of the benefits and risks, should prescribe LOTRONEX (see PRECAUTIONS: Prescribing Program for LOTRONEX).
    • LOTRONEX is indicated only for women with severe diarrhea-predominant IBS who have not responded adequately to conventional therapy (see INDICATIONS AND USAGE). Before receiving the initial prescription for LOTRONEX, the patient must read and sign the Patient-Physician Agreement for LOTRONEX (see PRECAUTIONS: Information for Patients).
    • 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 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 SUMMARY

    LOTRONEX®
    (alosetron hydrochloride)
    Tablets

    The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type.

    Because of serious gastrointestinal adverse events, some fatal, reported with use of this drug, 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
    • failed to respond 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

    Less than 5 percent of IBS is considered severe.

    In men, the safety and effectiveness of LOTRONEX have not been established (see CLINICAL TRIALS).


    See all Lotronex indications & dosage >>

    NEWS HIGHLIGHTS

    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.

    more studies >>

    Clinical Trials Related to Lotronex (Alosetron)

    LOTRONEX´┐Ż in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) [Recruiting]
    An observational study to evaluate LOTRONEX« in women with severe IBS-D in the current clinical practice setting.

    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) patients.

    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.

    more trials >>

    Reports of Suspected Lotronex (Alosetron) Side Effects

    Colitis Ischaemic (12)Abdominal Pain (2)Rectal Haemorrhage (2)Hepatic Failure (2)Condition Aggravated (2)Haematochezia (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

      Rating
    Overall rating:  
    Effectiveness:   Considerably Effective
    Side effects:   No Side Effects
      
    Treatment Info
    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
      
    Reported Results
    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)

    See all Lotronex reviews / ratings >>

    Page last updated: 2007-10-19

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