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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.
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
on behalf of the hospital pharmacy.
Have the authorized representative review the Alvimopan REMS Kit.
Have the authorized representative enroll in the Alvimopan REMS by
completing the Hospital Pharmacy Enrollment Form and submitting it to the
REMS.
| Hospital Pharmacy Enrollment Form |
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.
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 distribute 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
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.
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.
