Approved Risk Evaluation and Mitigation Strategies (REMS)
Alosetron
Shared System REMS
REMS last update: 08/05/2019
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 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 ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 206113 | PAR PHARM INC | 02/23/2018 | 9c359516-2981-4951-a672-ae2aa2cc10e7 | |
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:
- Informing prescribers of alosetron about:
- 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.
- the importance of counseling patients about the risks of IC and serious CoC.
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
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_2019_08_05_Letter_to_Healthcare_Providers.pdf |
Patient Education Sheet (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Patient_Education_Sheet.pdf |
Prescriber Completion of Alosetron REMS Program Training Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Prescriber_Completion_of_Alosetron_REMS_Program_Training_Form.pdf |
Prescriber Education Slide Deck (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Prescriber_Education_Slide_Deck.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_REMS_Full.pdf |
REMS Program Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_REMS_Program_Website_Screenshots.pdf |
Safety Information Fact Sheet for Prescribers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alosetron_2019_08_05_Safety_Information_Fact_Sheet_for_Prescribers.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
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.
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English