U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. REMS

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:

  1. 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.

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

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
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.

Back to Top