Approved Risk Evaluation and Mitigation Strategies (REMS)

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



What is the purpose of the REMS?

The goal of the E.A.S.E. ENTEREG REMS Program is to mitigate the potential risk of myocardial infarction by:

  1. Ensuring that ENTEREG (alvimopan) is used only for short-term use (no more than 15 doses) in a hospital inpatient setting.
  2. Informing healthcare providers about the potential risk of myocardial infarction observed with long-term use of ENTEREG.

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
Ongoing
  • 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.

Material Name Material Name Link
Dear Healthcare Provider Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_DHCP.pdf
E.A.S.E. ENTEREG REMS Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_Program_overview.pdf
Hospital Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_Pharmacy_Enrollment_Form.pdf
Prescriber and Pharmacist Information Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_Information_Brochure.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_REMS_document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Entereg_2016-06-01_REMS_full.pdf

What updates have been made to the REMS?

Date Summary of change
06/01/2016 Revised to change the application holder’s name or address
05/18/2016 Modified to remove graphics that bear the Cubist logo in the appended REMS materials and on the REMS website and updates to the REMS appended materials to reflect a change in name of the application owner.
10/18/2013 Modified to:

  1. Update ongoing activities related to prescriber and hospital pharmacist training and education and placed under the elements to assure safe use.
  2. Align with the revised indication make updates to REMS document, the REMS Program Overview, the Dear Healthcare Provider (DHCP) letter, and the Prescriber and Pharmacist Information Brochure
09/25/2012 Modified to:

  1. Update materials resulting from Cubist Pharmaceuticals acquisition of Entereg (alvimopan) from Adolor Corporation on December 1, 2011.
  2. Make a new hospital registration form with addition of checkboxes.
  3. Update the E.A.S.E. Program trademark and National Drug code (NDC).
02/05/2009 Modified to:

  1. Change the DEA line to “Hospital DEA #.” The word “hospital” was added to clarify that it cannot be a physician’s DEA number to the Hospital Registration form.
  2. Change the “Hospital Identification Number” to “Health Industry Number” and the asterisk indicating that this is a mandatory field was removed (i.e., this is no longer a mandatory field) to the Hospital Registration form.
  3. Add “Authorized Signatory” in front of the “Name” line and the “Middle Name” line removed to the Hospital Registration form.
  4. Add an asterisk to the “Title” line (making this a mandatory field) with check boxes to identify the individual as a hospital pharmacist or representative of the hospital’s Pharmacy and Therapeutics Committee to the Hospital Registration form.
  5. Change “Office Phone” to “Pharmacy Phone” and an asterisk was added (making this a mandatory field) to the Hospital Registration form.
  6. Change “Fax” to “Pharmacy Fax” and an asterisk was added (making this a mandatory field). The pharmacy phone and fax numbers will assist the Sponsor in confirming the information on the phone to the Hospital Registration form.
  7. Bold the statement “See Important Safety Information” and the words “including the Boxed Warning on the reverse side” were added to the top paragraph of the first page of the Hospital Registration form.
  8. Move the footer information from the front side to the reverse side of the form.
  9. Change and update the Adolor logo to the Hospital Registration form.
  10. Add a note to the bottom of the first page requesting a separate form for each ship site with an accompanying DEA number to the Hospital Registration form.
05/20/2008 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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