Approved Risk Evaluation and Mitigation Strategies (REMS)

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Lotronex (alosetron hydrochloride)
NDA #021107
REMS last update: 04/29/2016



What is the purpose of the REMS?

The goals and objectives of the LOTRONEX REMS are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with LOTRONEX and its authorized generic alosetron hydrochloride by:

  1. Informing prescribers of LOTRONEX/alosetron hydrochloride about:
    1. the serious risks of IC and serious CoC associated with LOTRONEX/alosetron hydrochloride.
    2. the importance of understanding that LOTRONEX/alosetron hydrochloride should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
    3. the important of counseling patients about the risks of IC and serious CoC .
  2. Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Lotronex

View additional drug-specific postmarket safety information from the FDA

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Lotronex REMS, see the DailyMed link(s).
Material Name Material Name Link
Patient Education Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Patient_Education_Sheet.pdf
Prescriber Completion of LOTRONEX REMS Program Training Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Prescriber_Completion_Training_Form.pdf
Prescriber Education Slide Deck (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Prescriber_Education_Slide_Deck.pdf
REM document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_full.pdf
REMS letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_letter_healthcare_Providers.pdf
REMS letter for Professional Societies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_letter_Professional_Societies.pdf
REMS website screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_REMS_website_screenshots.pdf
Safety Information Fact Sheet for Prescribers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lotronex_2016-04-29_Safety_Information_Fact_Sheet.pdf

What updates have been made to the REMS?

Date Summary of change
04/29/2016 Revised to change the applications holder’s name or address.
01/07/2016 Modified to:

  1. Modify the REMS Goals.
  2. Remove of the Medication Guide as an element of the REMS.
  3. Modify the elements to assure safe use, including:
    1. The training of healthcare providers who prescribe Lotronex/alosetron hydrochloride must continue to be provided to ensure the benefits of Lotronex/alosetron hydrochloride continue to outweigh the risks of ischemic colitis and serious complications of constipation.
    2. The prescriber training materials are to include the Prescriber Education Slide Deck and a Safety Information Fact Sheet for Prescribers to communicate the key risk messages associated with Lotronex/alosetron hydrochloride.
    3. Prescribers no longer need to affix prescribing program stickers to written prescriptions for Lotronex/alosetron hydrochloride.
    4. Pharmacies may dispense Lotronex/alosetron hydrochloride without a prescribing program sticker affixed to a paper prescription.
    5. The Patient Acknowledgement Form was modified to a Patient Education Sheet and will become the primary educational tool used by prescribers for counseling patients regarding the risks of Lotronex/alosetron hydrochloride.
07/24/2015 Modified to include an authorized generic, alosetron hydrochloride, in the REMS document and appended materials.
05/08/2014 Modified to make changes to the PPL Prescriber Enrollment Form including:
  1. Requesting the NPI number rather than the DEA number.
  2. Prompting for complete address information (i.e., street, city, state, and zip code).
  3. Adding a new facsimile number.
09/02/2010 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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