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The goals of the Lenalidomide REMS are as follows:
To prevent the risk of embryo-fetal exposure to lenalidomide.
To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for lenalidomide.
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 lenalidomide 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 lenalidomide 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 the
Lenalidomide REMS.
Females (adults and children) who can get pregnant who are prescribed
lenalidomide:
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 lenalidomide 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 lenalidomide; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide REMS education
materials; and being compliant with the REMS
requirements.
Receive counseling from the pharmacy on the embryo-fetal
toxicity with exposure to lenalidomide; contraception
requirements; pregnancy testing requirement; not taking
lenalidomide if pregnant, breastfeeding, or not using
contraception; and to immediately stop taking lenalidomide
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 lenalidomide; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide REMS education
materials; and being compliant with the REMS
requirements.
Receive counseling from the pharmacy on embryo-fetal
toxicity with exposure to lenalidomide; contraception
requirements; pregnancy testing requirement; not taking
lenalidomide if pregnant, breastfeeding or not using
contraception; and to immediately stop taking lenalidomide
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 lenalidomide 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 you may be
pregnant. Stop taking lenalidomide immediately.
Return unused lenalidomide to Lenalidomide REMS, the
prescriber, or the pharmacy that dispensed the
lenalidomide.
Adhere to safe-use conditions: Not sharing lenalidomide;
not breaking, chewing, or opening lenalidomide capsules;
and keeping lenalidomide out of reach of children.
Adult females who cannot get pregnant who are prescribed lenalidomide:
Before treatment initiation
Receive counseling from the prescriber on the benefits and
risks of lenalidomide 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 lenalidomide therapy; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide 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 lenalidomide therapy; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide 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 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 lenalidomide to Lenalidomide REMS, the
prescriber, or the pharmacy that dispensed the
lenalidomide.
Adhere to the safe-use conditions: Not sharing
lenalidomide; not breaking, chewing, or opening
lenalidomide capsules; and keeping lenalidomide out of
reach of children.
Female children who cannot get pregnant who are prescribed lenalidomide:
Before treatment initiation
Receive counseling on the benefits and risks of
lenalidomide from the prescriber 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 lenalidomide; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide REMS education
materials; and being compliant with the REMS
requirements.
Receive counseling from the pharmacy on informing the
lenalidomide 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 lenalidomide; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide REMS education
materials; and being compliant with the REMS
requirements.
Receive counseling from the pharmacy to inform the
lenalidomide 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 menses begins.
Return unused lenalidomide to Lenalidomide REMS, the
prescriber, or the pharmacy that dispensed the
lenalidomide.
Adhere to the safe-use conditions: Not sharing
lenalidomide; not breaking, chewing, or opening
lenalidomide capsules; and keeping lenalidomide out of
reach of children.
Males (adults and children) who are prescribed lenalidomide:
Before treatment initiation
Receive counseling from the prescriber on the benefits and
risks of lenalidomide, 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 lenalidomide; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide REMS education
materials; and being compliant with the REMS
requirements.
Receive counseling from the pharmacy on embryo-fetal
toxicity with exposure to lenalidomide; 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 lenalidomide; not sharing lenalidomide; not
donating blood; not breaking, chewing, or opening
lenalidomide capsules; instructions on dose and
administration; reading the Lenalidomide REMS education
materials; and being compliant with the REMS
requirements.
Receive counseling from the pharmacy on embryo-fetal
toxicity with exposure to lenalidomide; 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 lenalidomide to Lenalidomide REMS, the
prescriber, or the pharmacy that dispensed the
lenalidomide.
Adhere to safe-use conditions: Not sharing lenalidomide;
not breaking, chewing, or opening lenalidomide capsules;
and keeping lenalidomide out of reach of children.
Pharmacies that dispense lenalidomide 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 lenalidomide 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
lenalidomide 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 lenalidomide 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 have it picked up within 24 hours
of obtaining the confirmation number.
For females (adult and children) who can get pregnant ship
lenalidomide 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 lenalidomide,
except as authorized by 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 Lenalidomide 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 Lenalidomide 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 Lenalidomide 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
04/27/2026
Modified to consist of updates to ensure conformity with the Thalomid REMS and PS-Pomalidomide REMS by:
Incorporating the changes from the approved PS-Pomalidomide REMS to the
Lenalidomide REMS including removal of the Emergency Contraception
Brochure and incorporation of the emergency contraception information in the
Prescriber Guide and Patient Guide.
Updating the REMS Document with minor changes that are consistent with the
Risk Evaluation and Mitigation Strategy Document Technical Conformance Guide (January 2023) to add the risk to the administrative information section and add Section VI. Statutory Elements.
Updating the REMS Document to clarify the audit requirements.
Updating the REMS Program Pharmacy Training to align content and ensure
uniformity across the three REMS.
03/24/2023
Modified to:
Reflect transfer the Drug Master File (DMF) holder from Celgene Corporation to Bristol-
Myers Squibb Company (BMS).
Remove the Celgene logo and references to Celgene,
and include administrative updates (e.g., changes to contact department names).
Make editorial changes to the REMS website.
Change the address of the REMS web portal.
08/05/2021
Modified to:
Remove reference to the Prescriber mobile app in the Prescriber Enrollment Form and Prescriber Guide
Update disclosure language and add new checkbox for patients to request Lenalidomide REMS materials in the Patient-Physician Agreement Forms (PPAFs).
Add reference to Patient Companion app in the Pharmacy training, Patient Guide, and REMS Website.
05/21/2021
Approval of the Shared System 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.
