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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 THALOMID 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 the
Emergency Contraception Brochure. Provide a copy of the
materials to the patient.
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.
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 and the
Emergency Contraception Brochure.
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 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.
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 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.
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.
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 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.
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 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.
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
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 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.
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.
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.
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 (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.
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 (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.
Assessment Plan
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
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:
Remove reference to the previous REMS program names.
Remove the CD-ROM/desktop software as a method to enroll patients into the REMS.
Add clarifying language regarding contraception use requirements for contraception use by patients enrolled in the REMS.
Update the name of the Veterans Health Administration in the REMS document and the material.
Add a tear-off quick reference guide for prescribers in the REMS at a Glance appended material.
Add REMS contraception information for patients to be used by non-prescribing healthcare providers.
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:
Include a mobile applications to provide an additional platform to accomplish internet-capable REMS activities in the REMS materials.
Revise a timetable for submission of assessments.
09/12/2014
Modified to:
Remove the “Rules for Dispensing” section in the Education and Counseling Checklist for Pharmacies.
Update the current International Statistical Classification of Diseases and Related Health Problems (ICD) classifications in the Patient Prescription Forms.
11/15/2013
Modified to:
Harmonize the REMS with Revlimid (lenalidomide), and Pomalyst (pomalidomide) capsules.
Add and implement a pharmacy portal to facilitate pharmacy activity within the REMS.
Dispense Thalomid (thalidomide) through certified pharmacies
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:
Eliminate the requirement for the Medication Guide as an element of the REMS.
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.
