Approved Risk Evaluation and Mitigation Strategies (REMS)
Alvimopan Shared System REMS
Shared System REMS
REMS last update: 06/12/2023
What medicines are included in the REMS?
Product Name | Application Number | Application Holder | Added to REMS | DailyMed Link | FDA Link |
---|---|---|---|---|---|
Entereg (alvimopan) (Info at Drugs@FDA) | NDA 21775 | CUBIST PHARMS | 12/19/2019 | ||
alvimopan (Info at Drugs@FDA) | ANDA 208295 | WATSON LABS TEVA | 12/19/2019 | ||
alvimopan (Info at Drugs@FDA) | ANDA 216843 | ENDO OPERATIONS | 01/24/2023 | ||
alvimopan (Info at Drugs@FDA) | ANDA 217753 | HIKMA | 08/31/2023 |
What is the purpose of the REMS?
The goal of the Alvimopan REMS Program is to mitigate the potential risk of myocardial infarction by:
- Ensuring that alvimopan is used only for short-term use (no more than 15 doses) in a hospital inpatient setting.
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.
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
06/12/2023 | Modified to add audit language for wholesalers and distributors to align with the proposed Audit Plan, to include the risk the REMS addresses, and to add the Statutory Elements section to be consistent with the Format and Content of a REMS Document Guidance for Industry (January 2023). |
12/19/2019 | 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.