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Approved Risk Evaluation and Mitigation Strategies (REMS)

Shared System REMS
REMS last update: 05/18/2022

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
alosetron ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 206113 PAR PHARM INC 02/23/2018 9c359516-2981-4951-a672-ae2aa2cc10e7
alosetron ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200652 HIKMA 11/22/2016 e91c4a69-2ad5-4e21-a279-9e1302b1a3d3 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200652
alosetron ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 206647 AMNEAL PHARMS 12/22/2016 ba94ab71-11d7-4ce1-9b21-0b8c6a39e993 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206647
alosetron ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 209180 RISING 01/14/2019 7a6c2fbb-a76a-497e-8cf2-a6dca8945a9d
alosetron (Info at Drugs@FDA) ANDA 211621 EYWA PHARMA 09/17/2019
alosetron ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 213614 MANKIND PHARMA 09/09/2020 2846a244-7540-442b-81bc-638e641497ce&audience=consumer

What is the purpose of the REMS?

The goals and objectives of the Alosetron REMS Program are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with alosetron hydrochloride hereinafter, referred to as alosetron) by:

  1. Informing prescribers of alosetron about:
    1. the serious risks of IC and serious CoC associated with alosetron the importance of understanding that alosetron should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
    2. the importance 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 Alosetron

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 Alosetron REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
Letter to Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Letter_to_Healthcare_Providers.pdf
Patient Education Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Patient_Education_Fact_Sheet.pdf
Prescriber Completion of Alosetron REMS Program Training Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Prescriber_Completion_of_Alosetron_REMS_Program_Training_Form.pdf
Prescriber Education Slide Deck (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Prescriber_Education_Slide_Deck.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_REMS_Program_Website_Screenshots.pdf
Safety Information Fact Sheet for Prescribers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2022_05_18_Safety_Information_Fact_Sheet_for_Prescribers.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
05/18/2022 Revised to reflect editorial changes.
05/05/2022 Modified to make changes to the Prescriber Education Slide Deck to align with the REMS modification approved October 18, 2021 and add a link on the REMS website to the “Letter for Healthcare Providers” and to update the Terms of Use page version and date information.

Modified to:

  1. Update the REMS Letter to Healthcare Providers to remove information related to program changes that were made in 2016, as that information is no longer relevant to prescribers becoming newly trained
  2. Make changes to the REMS call center hours
  3. Remove the option for prescribers to mail the Prescriber Completion of Training Form
08/05/2019 Revised website screenshots to remove individual applicant names.
11/22/2016 Modified to reflect the inclusion of an additional ANDA into the alosetron 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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