Approved Risk Evaluation and Mitigation Strategies (REMS)

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Pomalyst (pomalidomide)
NDA #204026
REMS last update: 06/27/2017



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

Healthcare providers who prescribe Pomalyst must

To become certified to prescribe
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS program.
    | Prescriber Enrollment Form |
Before treatment initiation
During treatment; before each prescription
After treatment discontinuation; for 12 consecutive months
At all times
  • Report any pregnancies immediately to Celgene Customer Care.
  • Return unused product from patients to Celgene Customer Care.

Adult females of reproductive potential and female children of reproductive potential and/or their guardian who are prescribed Pomalyst

Before the first prescription
During treatment; before each prescription
  • Receive counseling from the prescriber on contraception and emergency contraception.
  • Receive counseling from the pharmacist.
  • Get a pregnancy test at an interval specified by the prescriber.
During treatment; every month
  • Complete a mandatory survey (phone or online).
During treatment
After treatment discontinuation; for at least four weeks
  • Adhere to the safe use conditions, including refraining from becoming pregnant.
At all times
  • Inform the prescriber if they become pregnant, misses a menstrual period, experiences unusual menstrual bleeding, stops using contraception, or thinks for any reason that she may be pregnant.
  • Return unused product to their prescriber or pharmacy.

Adult females not of reproductive potential who are prescribed Pomalyst

Before the first prescription
During treatment; before each prescription
  • Receive counseling from the prescriber on contraception and emergency contraception.
  • Receive counseling from the pharmacist.
During treatment; every six months
  • Complete a mandatory survey (phone or online).
At all times
  • Return unused product to their prescriber or pharmacy.

Female children not of reproductive potential and/or their guardian who are prescribed Pomalyst

Before the first prescription
During treatment; before each prescription
  • Receive counseling from the prescriber on contraception and emergency contraception.
  • Receive counseling from the pharmacist.
During treatment; every month
  • Complete a mandatory survey (phone or online).
At all times
  • Return unused product to their prescriber or pharmacy.

Adult males 18 years and older or male children 18 years and younger and/or their guardian who are prescribed Pomalyst

Before the first prescription
During treatment; before each prescription
  • Receive counseling from the prescriber on contraception and emergency contraception.
  • Receive counseling from the pharmacist.
During treatment; every month
  • Complete a mandatory survey (phone or online)
During treatment
  • Adhere to the safe use conditions, including not having unprotected sexual contact with a female who can become pregnant and wearing a latex condom every time the patient has sexual contact while the male patient is receiving treatment, during dose interruptions, even if the patient has had a successful vasectomy.
  • Do not donate sperm.
After treatment discontinuation; for at least four weeks
  • Adhere to the safe use conditions; including not having unprotected sexual contact with a female who can become pregnant and wearing a latex condom every time the patient has sexual contact, even if the patient has had a successful vasectomy.
  • Do not donate sperm.
At all times
  • Inform the prescriber if the patient has unprotected sexual contact with a female who can become pregnant, or if they think for any reason that the male patient’s sexual partner might be pregnant.
  • Return unused product to their prescriber or pharmacy.

Pharmacies that dispense Pomalyst must

To become certified to dispense
  • Receive training provided by Celgene.
Before dispensing
  • Counsel the patient using the Education and Counseling Checklist for Pharmacies.
    | Education and Counseling Checklist for Pharmacies |
  • Verify that a prescription authorization number is documented on the prescription.
  • Obtain authorization to dispense by obtaining a confirmation number from the Celgene Customer Care Call Center or by using the Celgene REMS Pharmacy Portal. Document the confirmation number on the prescription.
  • Dispense no more than a 28 day’s supply.
  • Dispense a subsequent prescription only if there are 7 days or less remaining on the existing prescription.
  • Do not dispense refills.
At all times
  • Return unused product from the patient or prescriber to the Celgene Customer Care.
  • Do not distribute, transfer, loan, or sell product.
  • Maintain records of each prescription dispensed and the corresponding completed Education and Counseling Checklist.
    | Education and Counseling Checklist for Pharmacies |
  • Comply with audits carried out by the Celgene 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. For a specific Medication Guide of a product in the Pomalyst REMS, see the DailyMed link(s).
Material Name Material Name Link
Celgene REMS Programs Pharmacy Training: the Pomalyst REMS Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Celgene_REMS_Programs_Pharmacy_Training.pdf
Celgene Risk Management Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Celgene_Risk_Management_Website_Screenshots.pdf
Education and Counseling Checklist for Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Education_and_Counseling_Checklist_for_Pharmacies.pdf
Emergency Contraception Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Emergency_Contraception_Brochure.pdf
Patient Guide to the Pomalyst REMS Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Guide.pdf
Patient Prescription Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Prescription_Form.pdf
Patient Prescription Form - Veterans Health Administration (VHA) Only (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Prescription_Form_Veterans_Health_Administration_VHA_Only.pdf
Patient Resource Pack Envelope (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Resource_Pack_Envelope.pdf
Patient Survey Reminder Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Patient_Survey_Reminder_Card.pdf
Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf
Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf
Patient-Physician Agreement Form for a Male Child (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Male_Child.pdf
Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf
Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf
Patient-Physician Agreement Form for an Adult Male (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_PPAF_Adult_Male.pdf
Pharmacy Certification Quiz (the Pomalyst REMS Program) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Pharmacy_Certification_Quiz.pdf
Pharmacy Guide to the Pomalyst REMS Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Pharmacy_Guide.pdf
Pomalyst REMS At-A-Glance (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_At_A_Glance.pdf
Pomalyst REMS Program Education and Prescribing Safety Kit (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Education_and_Prescribing_Safety_Kit.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Prescriber_Enrollment_Form.pdf
Prescriber Guide to Pomalyst REMS Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Prescriber_Guide.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Full.pdf
Welcome Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalyst_2017-06-27_Welcome_Letter.pdf

What updates have been made to the REMS?

Date Summary of change
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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