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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.
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 test result. Document and submit the
results to the REMS.
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
WARNINGS and the need to complete mandatory patient
surveys using the Patient Guide and Patient-Physician
Agreement Form. Provide a copy of the materials to the
patient.
| Patient Guide |
For females (adults and children) who can get pregnant:
Counsel the patient on contraception requirements and
emergency contraception using the Patient Guide and the
Emergency Contraception Brochure. Provide a copy of the
materials to the patient.
| Patient Guide |
| Emergency Contraception Brochure |
For males (adults and children): Counsel the patient on the
barrier contraception requirements and emergency
contraception using the Patient Guide and the Emergency
Contraception Brochure. Provide a copy of the materials to
the patient.
| Patient Guide |
| Emergency Contraception Brochure |
Obtain authorization by contacting the REMS 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.
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 contraception requirements and
emergency contraception using the Patient Guide and the
Emergency Contraception Brochure.
| Patient Guide |
| Emergency Contraception Brochure |
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 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.
.Return all unused product from patients to the 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 your 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 and the Emergency Contraception
Brochure.
Enroll into the REMS by completing the Patient-Physician
Agreement Form for Adult Female 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.
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
the 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 for at
least the first 4 weeks
Get a pregnancy test as directed by your 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 your 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
the 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 requirements; 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,
experience unusual menstrual bleeding, stop using
contraception, or think for any reason that they may be
pregnant. Stop taking thalidomide immediately.
Return unused thalidomide to the Thalidomide REMS,
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.
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 the 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 the 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 the Thalidomide REMS,
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 and 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.
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
the Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy to inform the
thalidomide 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 thalidomide; not sharing thalidomide; not donating
blood; not breaking, chewing, or opening thalidomide
capsules; instructions on dose and administration; reading
the Thalidomide REMS education materials; and being
compliant with the REMS requirements.
Receive counseling from the pharmacy to inform the
thalidomide prescriber when the patient begin 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.
13.Return unused thalidomide to the 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.
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.
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 the
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 and 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
the 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; 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.
| Patient Guide |
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 the 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
Designate an authorized representative to carry out the
certification process and oversee implementation and
compliance with the REMS on behalf of the Pharmacy.
Have the authorized representative review the following:
Pharmacy Guide, Pharmacy Training, and Prescribing
Information.
| Pharmacy Guide |
| Pharmacy Training |
Have the authorized representative enroll in the Thalidomide
REMS by completing the Pharmacy Enrollment Form and
submitting it to the Thalidomide REMS.
Have the authorized representative complete the
Pharmacy Certification Quiz and submit it to the REMS.
| Pharmacy Certification Quiz |
Train all relevant staff involved in counseling and dispensing
thalidomide on the Thalidomide REMS requirements using the
Pharmacy Training.
| Pharmacy Training |
Establish processes and procedures to identify new staff
involved in counseling and dispensing thalidomide and ensure
they are trained.
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 requirements 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
thalidomide 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 thalidomide and
additional safe-use requirements using the Education and
Counseling Checklist for Pharmacies.
| Education and Counseling Checklist for Pharmacies |
Verify that a prescription authorization number and patient
risk category are documented on each prescription through
the processes and procedures established as a requirement of
the REMS.
Obtain a confirmation number to dispense each prescription
by contacting the REMS 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 the date it was
obtained on the prescription.
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
thalidomide the same day the confirmation number is
obtained or it must be picked up within 24 hours of obtaining
the confirmation number.
To maintain certification to
dispense
Have any new authorized representative enroll in the
Thalidomide REMS by successfully completing the Pharmacy
Certification Quiz and Pharmacy Enrollment Form and
submitting both to the Thalidomide REMS.
| Pharmacy Enrollment Form |
| Pharmacy Certification Quiz |
At all times
Report pregnancies immediately to the Thalidomide REMS.
Do not distribute, transfer, loan, or sell thalidomide, except
with the permission of the REMS.
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 |
Comply with audits carried out by the 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
the Thalidomide REMS.
Wholesalers-distributors that distribute thalidomide must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies.
Train all relevant staff involved in distributing on the REMS
requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of distributions.
Comply with audits carried out by the Thalidomide REMS 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.
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
04/27/2023
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.