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To prevent the risk of embryo-fetal exposure to thalidomide.
To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for thalidomide.
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.
Healthcare providers who prescribe thalidomide must:
To become certified to prescribe
Review the drug’s Prescribing Information.
Enroll in the REMS by completing the Prescriber Enrollment
Form and submitting it to the REMS Program.
Review the following: Welcome Letter, Prescriber Guide,
and REMS Education and Prescribing Safety Kit.
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)
For all patients: Counsel the patient on the benefits and
risks of thalidomide therapy, including risks described in the
Boxed Warning and the need to complete mandatory
patient surveys using the Patient Guide and Patient-
Physician Agreement Form (PPAF). Provide a copy of the
materials to the patient.
For females (adults and children) who can get pregnant:
Counsel the patient on contraception requirements and
emergency contraception using the Patient Guide and
provide a copy to the patient.
For males (adults and children): Counsel the patient on the
barrier contraception requirements and emergency contraception using the Patient Guide and provide a copy
to the patient.
Enroll the patient by completing and submitting the
Agreement Form for Female Child Who Can Get Pregnant,
Agreement Form for Female Child Who Can Not Get
Pregnant, Agreement Form for Male Child, Agreement Form
for Adult Female Who Can Get Pregnant, Agreement Form
for Adult Female Who Can Not Get Pregnant, or Agreement
Form for Adult Male to the REMS Program.
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.
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.
For males (adults and children): Counsel the patient on the
barrier contraception requirements using the 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 Thalidomide
REMS.
Females (adults and children) who can get pregnant who are prescribed thalidomide:
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 thalidomide therapy and the need to complete the
patient survey, on contraception requirements and
emergency contraception.
Review the 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.
Complete the patient survey.
Receive counseling from the pharmacy on the benefits and
risks of thalidomide; not sharing thalidomide; not donating
blood; not breaking, chewing, or opening thalidomide
capsules; instructions on dose and administration; reading
Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy on the embryo-fetal
toxicity with exposure to thalidomide; contraception
requirements; pregnancy testing requirement; not taking
thalidomide if pregnant, breastfeeding, or not using
contraception; and to immediately stop taking thalidomide
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, 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 thalidomide; not sharing thalidomide; not donating
blood; not breaking, chewing, or opening thalidomide
capsules; instructions on dose and administration; reading
Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy on embryo-fetal
toxicity with exposure to thalidomide; contraception requirements; pregnancy testing requirement; not taking
thalidomide if pregnant, breastfeeding, or not using
contraception; and to immediately stop taking thalidomide
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 thalidomide if pregnant,
breastfeeding, or not using contraception; and not
getting pregnant.
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 thalidomide immediately.
Return unused thalidomide to Thalidomide REMS, the
prescriber, or the pharmacy that dispensed the
thalidomide.
Adhere to safe-use conditions: Not sharing thalidomide;
not breaking, chewing, or opening thalidomide capsules;
and keeping thalidomide out of reach of children.
Adult females who cannot get pregnant who are prescribed thalidomide:
Before treatment initiation
Receive counseling from the prescriber on the benefits
and risks of thalidomide and the need to complete the
patient survey.
Review the 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.
Receive counseling from the pharmacy on the benefits and
risks of thalidomide therapy; not sharing thalidomide; not
donating blood; not breaking, chewing, or opening
thalidomide capsules; instructions on dose and
administration; reading Thalidomide 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 thalidomide therapy; not sharing thalidomide;
not donating blood; not breaking, chewing, or
opening thalidomide capsules; instructions on dose
and administration; reading Thalidomide 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 thalidomide to Thalidomide REMS,
the prescriber, or the pharmacy that dispensed
the thalidomide.
Adhere to the safe-use conditions: Not sharing thalidomide;
not breaking, chewing, or opening thalidomide capsules;
and keeping thalidomide out of reach of children.
Female children who cannot get pregnant who are prescribed thalidomide:
Before treatment initiation
Receive counseling from the prescriber on the benefits
and risks of thalidomide and the need to complete the
patient survey.
Review the 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.
Complete the patient survey.
Receive counseling from the pharmacy on the benefits and
risks of thalidomide; not sharing thalidomide; not donating
blood; not breaking, chewing, or opening thalidomide
capsules; instructions on dose and administration; reading
Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy on informing the
thalidomide prescriber when menses begins.
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 thalidomide; not sharing thalidomide; not donating
blood; not breaking, chewing, or opening thalidomide
capsules; instructions on dose and administration; reading
Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy to inform the
thalidomide prescriber when menses begins.
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 thalidomide to Thalidomide REMS,
the prescriber, or the pharmacy that dispensed
the thalidomide.
Adhere to the safe-use conditions: Not sharing
thalidomide; not breaking, chewing, or opening
thalidomide capsules; and keeping thalidomide out
of reach of children.
Males (adults and children) who are prescribed thalidomide:
Before treatment initiation
Receive counseling from the prescriber on the benefits and
risks of thalidomide, the need to complete the patient
survey, barrier contraception requirements, and
emergency contraception.
Review the 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 thalidomide; not sharing thalidomide; not donating
blood; not breaking, chewing, or opening thalidomide
capsules; instructions on dose and administration; reading
Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy on embryo-fetal
toxicity with exposure to thalidomide; barrier
contraception requirements; and not donating sperm.
During treatment;
before each prescription
Receive counseling from the prescriber on barrier
contraception requirements, emergency contraception, and
the need to complete the patient survey.
Receive counseling from the pharmacy on the benefits and
risks of thalidomide; not sharing thalidomide; not donating
blood; not breaking, chewing, or opening thalidomide
capsules; instructions on dose and administration; reading
Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy on embryo-fetal
toxicity with exposure to thalidomide; barrier
contraception requirements; and not donating sperm.
Complete the patient survey.
During treatment and after
treatment discontinuation;
for 4 weeks
Adhere to the safe-use conditions: Using barrier
contraception as described in the Patient Guide and
Patient-Physician Agreement Form.
Adhere to the safe-use conditions: Not donating blood
or sperm.
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 thalidomide to Thalidomide REMS,
the prescriber, or the pharmacy that dispensed
the thalidomide.
Adhere to safe-use conditions: Not sharing thalidomide;
not breaking, chewing, or opening thalidomide capsules;
and keeping thalidomide out of reach of children.
Pharmacies that dispense thalidomide must:
To become certified to dispense
Review the following: 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 thalidomide, and safe-use conditions using the
Education and Counseling Checklist for Pharmacies.
For females (adults and children) who can get pregnant,
counsel on the embryo-fetal toxicity with exposure to
thalidomide and her safe-use conditions using the
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.
For males (adults and children): Counsel the patient on the
embryo-fetal toxicity with exposure to thalidomide and
additional safe-use conditions using the 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.
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 (adults and children) who can get pregnant:
Ship thalidomide the same day the confirmation number
is obtained, or have it 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 thalidomide, 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.
Comply with audits carried out by Thalidomide REMS to
ensure that all processes and procedures are in place and
are being followed.
Accept unused product from the patient or the prescriber.
Return unused product from the patient or the prescriber
to Thalidomide REMS.
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 Thalidomide REMS REMS, see the DailyMed link on the Products tab.
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
09/02/2026
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.
