Approved Risk Evaluation and Mitigation Strategies (REMS)

Contact Us | REMS Basics | Gov Delivery Get REMS Email Alerts | Data Files

Alosetron (alosetron)
ANDA #200652
REMS last update: 03/24/2016

View the Alosetron Prescribing Information and Medication Guide at DailyMed.
View Alosetron's Regulatory Information at Drugs@FDA

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 Alosetron

  • Receive training provided by the REMS program.
  • Review the drug’s prescribing information.
  • Review the educational materials: REMS letter for Healthcare Provider, Prescriber Education Slide Deck, Safety Information Fact Sheet for Prescribers, and Patient Education Sheet.
  • Report the completion of training to the REMS program using the Prescriber Completion of Alosetron REMS program Training Form.

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:


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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.