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Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Thalomid (thalidomide)
NDA #020785
REMS last update: 03/24/2023



What is the purpose of the REMS?

The goals of the THALOMID REMS are as follows:

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

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 THALOMID must:

To become certified to prescribe
Before treatment initiation (first prescription); within 10- 14 days and again within 24 hours
  • For females (adults and children) who can get pregnant: Assess the patient’s pregnancy status by ordering and confirming a negative pregnancy test result. Document and submit the result to the REMS Program.
Before treatment initiation (first prescription)
During treatment; weekly for at least the first 4 weeks
  • For females (adults and children) who can get pregnant: Assess the patient's pregnancy status by ordering and reviewing the results of her pregnancy test.
During treatment; every 2 weeks after the first 4 weeks
  • For females (adults and children) with irregular menstrual cycles who can get pregnant: Assess the patient's pregnancy status by ordering and reviewing the results of her pregnancy test.
During treatment; every 4 weeks after the first 4 weeks
  • For females (adults and children) with regular menstrual cycles who can get pregnant: Assess the patient's pregnancy status by ordering and reviewing the results of her pregnancy test. Document and submit the results to the REMS Program.
During treatment: before each prescription
  • For all patients: Counsel the patient on the need to complete the patient survey.
  • For females (adults and children) who can get pregnant: Counsel the patient on using contraception requirements and emergency contraception using the Patient Guide and the Emergency Contraception Brochure.
    | Emergency Contraception Brochure | | Patient Guide |
  • For males (adults and children): Counsel the patient on the barrier contraception requirements using the Patient Guide.
    | Patient Guide |
  • Obtain authorization by contacting the REMS Program to complete the prescriber survey to verify the patient’s reproductive status, negative pregnancy test status, and completion of counseling. Document the prescription authorization number and the patient’s risk category on the prescription.
  • Prescribe no more than a 28 days’ supply.
  • Not prescribe refills or prescribe over the phone.
At all times
  • Report any pregnancies in female patients or female partners of male patients immediately to the REMS Program.
  • Return all unused product from patients to the THALOMID REMS.

Females (adults and children) who can get pregnant who are prescribed THALOMID:

Before treatment initiation;4 weeks
  • Adhere to the safe use conditions: using contraception and not getting pregnant as described in the Patient Guide and the Patient-Physician Agreement Form.
Before treatment initiation; within 10-14 days and again within 24 hours
  • Get a pregnancy test as directed by the prescriber.
Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of THALOMID therapy and the need to complete the patient survey, on contraception requirements and emergency contraception.
  • Review the Patient Guide and the Emergency Contraception Brochure.
    | Emergency Contraception Brochure | | Patient Guide |
  • Enroll into the REMS Program by completing the Patient-Physician Agreement Form for Adult Females Who Can Get Pregnant or Patient-Physician Agreement Form for Female Child Who Can Get Pregnant with the prescriber. Enrollment information will be provided to the REMS Program.
    | Patient-Physician Agreement Form for Female Child Who Can Get Pregnant | | Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant |
  • Complete the patient survey.
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on the embryo-fetal toxicity with exposure to THALOMID; contraception requirements; pregnancy testing requirement; not taking THALOMID if pregnant, breastfeeding, or not using contraception; and to immediately stop taking THALOMID and notify the prescriber if pregnant or suspect they may be pregnant.
During treatment; weekly at least the first 4 weeks
  • Get a pregnancy test as directed by the prescriber.
During treatment; before each prescription
  • Receive counseling from the prescriber on contraception requirements and emergency contraception and the need to complete the patient survey.
  • Get a pregnancy test as directed by the prescriber.
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryofetal toxicity with exposure to THALOMID; contraception requirements; pregnancy testing requirement; not taking THALOMID if pregnant, breastfeeding or not using contraception; and to immediately stop taking THALOMID and notify the prescriber if pregnant or suspect they may be pregnant.
  • Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks
  • Adhere to the safe-use conditions: Not donating blood.
  • Adhere to the safe-use conditions: Using contraception as described in the Patient Guide and the Patient-Physician Agreement Form; not taking THALOMID if pregnant, breastfeeding, or not using contraception; and not getting pregnant.
    | Patient Guide |
At all times
  • Inform the prescriber if pregnant, miss a menstrual period, experiences unusual menstrual bleeding, stops using contraception, or think for any reason that you may be pregnant. Stop taking THALOMID immediately.
  • Return unused THALOMID to the THALOMID REMS, the prescriber, or the pharmacy that dispensed their THALOMID.
  • Adhere to safe-use conditions: Not sharing THALOMID; not breaking, chewing, or opening THALOMID capsules; and keeping THALOMID out of reach of children.

Adult females who cannot get pregnant who are prescribed THALOMID:

Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of THALOMID and the need to complete the patient survey.
  • Review the Patient Guide.
    | Patient Guide |
  • Complete the patient survey.
  • Enroll into the REMS Program by completing the Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant with the prescriber. Enrollment information will be provided to the REMS Program.
    | Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant |
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID therapy; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
During treatment; before each prescription
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID therapy; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
During treatment; every 6 months
  • Receive counseling from the prescriber on the need to complete the patient survey.
  • Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks
  • Adhere to the safe-use conditions: Not donating blood.
At all times
  • Return unused THALOMID to the THALOMID REMS, the prescriber, or the pharmacy that dispensed their THALOMID.
  • Adhere to the safe-use conditions: Not sharing THALOMID; not breaking, chewing, or opening THALOMID capsules; and keeping THALOMID out of reach of children.

Female children who cannot get pregnant who are prescribed THALOMID:

Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of THALOMID and the need to complete the patient survey.
  • Review the Patient Guide.
    | Patient Guide |
  • Enroll into the REMS Program by completing the Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant with the prescriber. Enrollment information will be provided to the REMS Program.
    | Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant |
  • Complete the patient survey.
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on informing the THALOMID prescriber when the patient begins menses.
During treatment; before each prescription
  • Receive counseling from the prescriber on the need to complete the patient survey.
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy to inform the THALOMID prescriber when the patient begins menses.
  • Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks
  • Adhere to the safe-use conditions: not donating blood.
At all times
  • Inform the prescriber when the patient begins menses.
  • Return unused THALOMID to the THALOMID REMS, the prescriber, or the pharmacy that dispensed their THALOMID.
  • Adhere to the safe-use conditions: Not sharing THALOMID; not breaking, chewing, or opening THALOMID capsules; and keeping THALOMID out of reach of children.

Males (adults and children) who are prescribed THALOMID:

Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of THALOMID, the need to complete the patient survey, barrier contraception requirements, and emergency contraception.
  • Review the Patient Guide and the Emergency Contraception Brochure.
    | Emergency Contraception Brochure | | Patient Guide |
  • Enroll into the REMS Program by completing a Patient-Physician Agreement Form for Adult Male or Patient-Physician Agreement Form for Male Child with the prescriber. Enrollment information will be provided to the REMS Program.
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryofetal toxicity with exposure to THALOMID; barrier contraception requirements; and not donating sperm.
During treatment; before each prescription
  • Receive counseling from the prescriber on barrier contraception requirements and emergency contraception, and the need to complete the patient survey.
  • Receive counseling from the pharmacy on the benefits and risks of THALOMID; not sharing THALOMID; not donating blood; not breaking, chewing, or opening THALOMID capsules; instructions on dose and administration; reading the THALOMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryofetal toxicity with exposure to THALOMID; barrier contraception requirements; and not donating sperm.
  • Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks
At all times
  • Inform the prescriber about unprotected sexual contact with a female who can become pregnant, or about a sexual partner who might be pregnant.
  • Return unused THALOMID to the THALOMID REMS, the prescriber, or the pharmacy that dispensed their THALOMID.
  • Adhere to safe-use conditions: Not sharing THALOMID; not breaking, chewing, or opening THALOMID capsules; and keeping THALOMID out of reach of children.

Pharmacies that dispense THALOMID must:

To become certified to dispense
  • Review the following: Pharmacy Guide, REMS Program Pharmacy Training, Pharmacy Certification Quiz.
    | Pharmacy Guide | | REMS Program Pharmacy Training | | Pharmacy Certification Quiz |
  • Establish processes and procedures to verify there are 7 days or less remaining on the patient’s existing prescription, no more than 28 days’ supply is dispensed, and the prescriber provided the authorization number and patient risk category on the prescription.
Before dispensing
  • For all patients: Counsel the patient on the benefits and risks of THALOMID, and safe-use conditions using the Education and Counseling Checklist for Pharmacies.
    | Education and Counseling Checklist for Pharmacies |
  • For females (adult and children) who can get pregnant, counsel on the embryo-fetal toxicity with exposure to THALOMID and her safe-use conditions using the Education and Counseling Checklist for Pharmacies.
    | Education and Counseling Checklist for Pharmacies |
  • For female children who cannot get pregnant: Counsel the patient to inform the prescriber when menses begins using the Education and Counseling Checklist for Pharmacies.
    | Education and Counseling Checklist for Pharmacies |
  • For males (adult and children): Counsel the patient on the embryo-fetal toxicity with exposure to THALOMID and additional safe-use conditions using the Education and Counseling Checklist for Pharmacies.
    | Education and Counseling Checklist for Pharmacies |
  • Verify that a prescription authorization number and patient risk category is documented on each prescription through the processes and procedures established as a requirement of the REMS Program.
  • Obtain confirmation number to dispense each prescription by contacting the REMS Program to verify the prescriber is certified, the patient is enrolled and is not pregnant, and the authorization number is valid.
  • Document the confirmation number and date it was obtained on the prescription.
  • Complete the Education and Counseling Checklist for Pharmacies. Retain a completed copy in the patient’s record.
    | Education and Counseling Checklist for Pharmacies |
  • Dispense no more than a 28 days’ supply.
  • Dispense only if there are 7 days or less remaining on the existing prescription.
  • Do not accept verbal prescription orders over the phone.
  • Do not dispense refills.
After dispensing
  • Ship dispensed product within 24 hours of receiving the confirmation number or it must be picked up within 24 hours of obtaining the confirmation number.
  • For females (adult and children) who can get pregnant ship THALOMID the same day the confirmation number is obtained, or it must be picked up within 24 hours of obtaining the confirmation number.
At all times
  • Report pregnancies immediately to the REMS Program.
  • Do not distribute, transfer, loan, or sell THALOMID, except with the permission of the REMS Program.
  • Maintain records of each prescription dispensed with the corresponding confirmation number, date it was obtained, and completed Education and Counseling Checklist for Pharmacies.
    | Education and Counseling Checklist for Pharmacies |

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 Thalomid REMS, see the DailyMed link(s).
Material Name Material Name Link
BMS REMS Patient Safety Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_BMS_REMS_Patient_Safety_Website.pdf
Education and Counseling Checklist for Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Education_and_Counseling_Checklist_for_Pharmacies.pdf
Emergency Contraception Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Emergency_Contraception_Brochure .pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ Thalomid_2023_03_24_Patient_Guide .pdf
Patient Resource Pack Envelope (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Resource_Pack_Envelope.pdf
Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf
Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Not_Get_Pregnant.pdf
Patient-Physician Agreement Form for Adult Male (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Adult_Male .pdf
Patient-Physician Agreement Form for Female Child Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant .pdf
Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Not_Get_Pregnant .pdf
Patient-Physician Agreement Form for Male Child (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Patient_Physician_Agreement_Form_for_Male_Child.pdf
Pharmacy Certification Quiz (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Pharmacy_Certification_Quiz.pdf
Pharmacy Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Pharmacy_Guide .pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Prescriber Enrollment Form .pdf
Prescriber Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Prescriber_Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Document.pdf
REMS Education and Prescribing Safety Kit (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Education_and Prescribing_Safety_Kit.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Full.pdf
REMS Program Pharmacy Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Program_Pharmacy_Training .pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_REMS_Program_Website_Screenshots.pdf
Welcome Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2023_03_24_Welcome_Letter .pdf

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 reflect transfer of application ownership from Celgene to Bristol-Myers Squibb Company (BMS), removing the Celgene logo and references to Celgene, and includes updates (e.g., changes to contact department names). The modification also consists of editorial changes to the REMS website, and changing the address of the REMS web portal.
08/05/2021 Modified to:
  • remove the mobile app for physicians
  • include the Patient REMS Application
  • clarify language regarding the question for prescribers about days of therapy being prescribed
  • add new language for reporting pregnancies
  • change the disclosure language on the Patient-Physician Agreement Forms (PPAFs)
  • add new election checkbox on the PPAFs for patients to request Thalomid REMS education materials
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 requirements for contraception use by patients enrolled in the REMS.
  4. Update the name of the Veterans Health Administration in the REMS document and the 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.
06/09/2017 Modified to remove reference to the previous names of the REMS from REMS documents, remove the CD-ROM/desktop software as avenues to enroll patients into the REMS, add clarifying language regarding contraception use within the REMS, update the name of the Veterans Health Administration, add a tear-off quick reference guide for prescribers, add a REMS contraception information piece for patients to use with non-prescribing healthcare providers, introduce a revised protocol for obtaining pregnancy exposure information within the pregnancy registry, remove language related to the launch of the REMS mobile app from the REMS Supporting Document, remove reference from the REMS Supporting Document to an informational webinar that occurred in the past, include language in the REMS Supporting Document regarding the assessment that must accompany efficacy supplements, and include an updated brochure regarding emergency contraception to the approved risk evaluation and mitigation strategy (REMS).
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 insert 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).
09/13/2015 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.
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. Harmonize the REMS with Revlimid (lenalidomide), and Pomalyst (pomalidomide) capsules.
  2. Add and implement a pharmacy portal to facilitate pharmacy activity within the REMS.
  3. Dispense Thalomid (thalidomide) through certified pharmacies
  4. Harmonize the training that pharmacists receive to dispense Thalomid (thalidomide) capsules with the training pharmacists receive for Revlimid (lenalidomide) and Pomalyst (pomalidomide) capsules.
02/08/2013 Modified to:

  1. Eliminate the requirement for the Medication Guide as an element of the REMS.
  2. Harmonize the REMS programs for Revlimid (lenalidomide) capsules and Thalomid (thalidomide) capsules.
08/03/2010 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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