Approved Risk Evaluation and Mitigation Strategies (REMS)

Alvimopan Shared System REMS
Shared System REMS
REMS last update: 12/19/2019

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

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

Healthcare settings that dispense alvimopan must:

To become certified to dispense
  • Have a pharmacy in an inpatient hospital that performs bowel resection surgery.
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the hospital pharmacy.
  • Have the authorized representative review the Alvimopan REMS Kit
  • Have the authorized representative enroll in the Alvimopan REMS Program by completing the Hospital Pharmacy Enrollment Form and submitting it to the REMS Program.
  • Train all relevant staff involved in prescribing, dispensing, or administering on safe use of alvimopan using the Alvimopan REMS Kit materials.
  • Establish processes and procedures to verify no more than 15 doses are dispensed to the patient
Before dispensing
  • Verify the patient receives no more than 15 doses through the processes and procedures established as a requirement of the REMS Program.
At all times
  • Not dispense alvimopan for outpatient use
  • Not distribute, transfer, loan, or sell alvimopan, except to certified healthcare settings.
  • Re-certify in the Alvimopan REMS if the authorized representative changes
  • Comply with audits carried out by alvimopan applicants or a third party acting on behalf of the applicants to ensure that all processes and procedures are in place and are being followed

Wholesalers-Distributors that distribut alvimopan must:

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified healthcare settings.
  • Train all relevant staff involved in distributing alvimopan on REMS program requirements.
At all times
  • Distribute only to certified healthcare settings.
  • Maintain records of drug distribution.
  • Comply with audits carried out by the applicants or a third party acting on behalf of the applicants to ensure that all processes and procedures are in place and are being followed.

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.

Material Name Material Name Link
Alvimopan REMS Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Alvimopan_REMS_Program_Overview.pdf
Dear Healthcare Provider Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Dear_Healthcare_Provider_Letter.pdf
Hospital Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Hospital_Enrollment_Form.pdf
Prescriber and Pharmacist Information Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_Prescriber_and_Pharmacist_Information_Brochure.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Alvimopan_Shared_System_REMS_2019_12_19_REMS_Full.pdf

What updates have been made to the REMS?

Date Summary of change
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.

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