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Approved Risk Evaluation and Mitigation Strategies (REMS)

Pomalyst (pomalidomide)
NDA #204026
REMS last update: 03/24/2023



What is the purpose of the REMS?

The goals of the POMALYST risk evaluation and mitigation strategy are as follows:

  1. To prevent the risk of embryo-fetal exposure to POMALYST.
  2. To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.

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
03/24/2023 Modified to:
  1. Transfer the application ownership from Celgene to Bristol-Myers Squibb Company (BMS).
  2. Remove the Celgene logo and references to Celgene.
  3. Make administrative updates such as changes to contact department names.
  4. Make editorial changes to the REMS website.
  5. Change the address of the REMS web portal.
08/05/2021 Modified to remove the mobile app for physicians, inclusion of the Patient REMS Application, clarifying language regarding the question for prescribers about days of therapy being prescribed, new language for reporting pregnancies, modification to the disclosure language on the Patient-Physician Agreement Forms (PPAFs), and a new election checkbox on the PPAFs for patients to request Pomalyst REMS education materials.
05/14/2020 Modified to remove indication statements from REMS materials; modified the REMS document to the new format to align with the recommendations in the October 2017 Draft Guidance: Format and Content of a REMS Document for Industry; and remove prescription forms from the REMS.
06/27/2017 Modified to:

  1. Remove reference to the previous REMS program names.
  2. Remove the CD-ROM/desktop software as a method to enroll patients into the REMS.
  3. Add clarifying language regarding contraception use by patients enrolled in the REMS.
  4. Update the name of the Veterans Health Administration in the REMS document and material.
  5. Add a tear-off quick reference guide for prescribers in the REMS at a Glance appended material.
  6. Add REMS contraception information for patients to be used by non-prescribing healthcare providers.
  7. Add an updated brochure regarding emergency contraception.
04/22/2016 Modified to change the contact information for emergency contraception information, add flow charts to the Prescriber Guide and the Patient Guide for clarity, add clarifying language to the prescriber enrollment forms about the authorization number, add unacceptable forms of birth control to the Education and Counseling Checklist and Patient Prescriber Agreement Forms (PPAFs), replace “doctor” with “healthcare provider” throughout the PPAF, change the trademark symbols to registered trademark symbols, and inserting a “Forgot Password” screenshot in the Celgene Risk Management Website User Guide.
12/01/2015 Modified to add links to Spanish language REMS materials to the REMS website, add additional links from CelgeneRiskManagement.com to the individual product REMS websites, add functionality to the Prescriber Calendar, Review Authorization, and Reports in the prescriber portal in CelgeneRiskManagement.com.
10/27/2015 Modified to remove the ICD-10 code from the Patient Prescription Forms (General Patient Prescription Form and Veterans Administration Patient Prescription Form).
09/14/2015 Modified to:

  1. Include a mobile applications to provide an additional platform to accomplish internet-capable REMS activities in the REMS materials
  2. Revise a timetable for submission of assessments.
04/23/2015 Modified to revise the indication statement and information about arterial thromboembolism in the appended REMS materials.
09/12/2014 Modified to:

  1. Remove the “Rules for Dispensing” section in the Education and Counseling Checklist for Pharmacies.
  2. Update the current International Statistical Classification of Diseases and Related Health Problems (ICD) classifications in the Patient Prescription Forms.
11/15/2013 Modified to:

  1. Add and implement a pharmacy portal to facilitate pharmacy activity within the REMS.
  2. Harmonize the REMS with the Thalomid (thalidomide) capsules and Revlimid (lenalidomide) capsules REMS.
  3. Include the implementation of a survey of contraceptive use in females of reproductive potential and a survey of knowledge for pharmacists in the REMS assessment plan.
02/08/2013 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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