Approved Risk Evaluation and Mitigation Strategies (REMS)

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Entereg (alvimopan)
NDA #021775
REMS last update: 06/01/2016

View the Entereg Prescribing Information at DailyMed
View Entereg's Regulatory Information at Drugs@FDA

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

Hospital pharmacies that dispense Entereg

To be able to dispense Entereg
  • Designate an authorized representative to carry out the certification process on behalf of the healthcare setting.
  • Have the authorized representative: review the educational materials for dispensers, including: Program Kit.
  • Train all relevant staff involved in the dispensing of Entereg on the benefits and risks and safe use.
  • Establish processes and procedures to verify that no more than 15 doses are administered per patient.
  • Enroll in the REMS by completing and submitting the Hospital Pharmacy Enrollment Form.
  • Do not dispense for outpatient use.
  • Do not distribute, transfer, loan, or sell product except to certified dispensers.

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:

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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