Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Revlimid (lenalidomide)
NDA #021880
REMS last update: 05/28/2019



What is the purpose of the REMS?

The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:

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

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 REVLIMID 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.
    | Welcome Letter |
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 REVLIMID 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 (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 emerency 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.
    | Patient-Physician Agreement Form - Adult Female Who Can Not Get Pregant |
  • 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.
  • Provide prescription to a REVLIMID REMS certified pharmacy only.
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 Celgene.

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

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 REVLIMID 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 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 your 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 REVLIMID; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on the embryo-fetal toxicity with exposure to REVLIMID; contraception requirements; pregnancy testing requirement; not taking REVLIMID if pregnant, breastfeeding, or not using contraception; and to immediately stop taking REVLIMID and notify the prescriber if pregnant or suspect you may be pregnant.
During treatment; weekly at least the first 4 weeks
  • Get a pregnancy test as directed by your prescriber.
During treatment; before each prescription
  • Receive counseling from your 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 REVLIMID; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryo-fetal toxicity with exposure to REVLIMID; contraception requirements; pregnancy testing requirement; not taking REVLIMID if pregnant, breastfeeding or not using contraception; and to immediately stop taking REVLIMID and notify the prescriber if pregnant or suspect you 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 REVLIMID 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 REVLIMID immediately.
  • Return unused REVLIMID to Celgene, your prescriber, or the pharmacy that dispensed your REVLIMID.
  • Adhere to safe-use conditions: Not sharing REVLIMID; not breaking, chewing, or opening REVLIMID capsules;and keeping REVLIMID out of reach of children.

Adult females who cannot get pregnant who are prescribed REVLIMID:

Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of REVLIMID 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 REVLIMID therapy; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID 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 REVLIMID therapy; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID 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 aftertreatment discontinuation; for 4 weeks
  • Adhere to the safe-use conditions: Not donating blood.
At all times
  • Return unused REVLIMID to Celgene, the prescriber, or the pharmacy that dispensed your REVLIMID.
  • Adhere to the safe-use conditions: Not sharing REVLIMID; not breaking, chewing, or opening REVLIMID

Female children who cannot get pregnant who are prescribed REVLIMID:

Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of REVLIMID from the prescriber and the need to complete the patient survey.
  • Review the Patient Guide.
  • Enroll into the REMS Program by completing a 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 REVLIMID; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on informing your REVLIMID 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 REVLIMID; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy to inform your REVLIMID 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 your prescriber when menses begins.
  • Return unused REVLIMID to Celgene, your prescriber, or the pharmacy that dispensed your REVLIMID.
  • Adhere to the safe-use conditions: Not sharing REVLIMID; not breaking, chewing, or opening REVLIMID capsules;and keeping REVLIMID out of reach of children.

Males (adults and children) who are prescribed REVLIMID:

Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of REVLIMID, 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 REVLIMID; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryo-fetal toxicity with exposure to REVLIMID; 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 REVLIMID; not sharing REVLIMID; not donating blood; not breaking, chewing, or opening REVLIMID capsules; instructions on dose and administration; reading the REVLIMID REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryo-fetal toxicity with exposure to REVLIMID; barrier contraception requirements; and not donating sperm.
  • Complete the patient survey.
During treatment and aftertreatment 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 REVLIMID to Celgene, your prescriber, or the pharmacy that dispensed your REVLIMID.
  • Adhere to safe-use conditions: Not sharing REVLIMID; not breaking, chewing, or opening REVLIMID capsules; and keeping REVLIMID out of reach of children.

Pharmacies that dispense REVLIMID must:

To become certified to dispense
  • Review the following: Pharmacy Guide, REMS Program Pharmacy Training, Pharmacy Certification Quiz.
    | 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 REVLIMID 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 REVLIMID 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 REVLIMID 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 REVLIMID 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 REVLIMID, 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 Celgene 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 Celgene.

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 Revlimid REMS, see the DailyMed link(s).
Material Name Material Name Link
Celgene Risk Management Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Celgene Risk Management Website Screenshots.pdf
Education and Counseling Checklist for Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Education and Counseling Checklist for Pharmacies.pdf
Education and Prescribing Safety Kit (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Education and Prescribing Safety Kit.pdf
Emergency Contraception Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Emergency Contraception Guide.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Guide.pdf
Patient Resource Pack (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Patient Resource Pack.pdf
Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimd 2019 05 28 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/ Revlimid 2019 05 28 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/Revlimid 2019 05 28 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/Revlimd 2019 05 28 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/Revlimid 2019 05 28 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/Revlimid 2019 05 28 Patient Physician Agreement Form for Male Child.pdf
Pharmacy Certification Quiz (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Pharmacy Certification Quiz.pdf
Pharmacy Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Pharmacy Guide.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Prescriber Enrollment Form.pdf
Prescriber Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Prescriber Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Full.pdf
REMS Program Pharmacy Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 REMS Program Pharmacy Training.pdf
Welcome Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid 2019 05 28 Welcome Letter.pdf

What updates have been made to the REMS?

Date Summary of change
05/28/2019 Modified to remove indication statements from REMS materials,convert the REMS document into the current template and remove prescription forms from the REMS.
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.
02/22/2017 Modified to include a new indication in the Patient Prescription Forms, Prescriber Guide to REVLIMID REMS Program, Celgene Risk Management.com website, and the Welcome Letter.
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 inserting 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, and 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.
02/17/2015 Modified to incorperate the new proposed indication for Revlimid (lenalidomide) in combination with dexamethasone for the treatment of multiple myeloma in the Prescriber Guide to the Revlimid REMS Program, Revlimid Risk Evaluation and Mitigation Strategy (REMS) Program Education and Safety Kit, Revlimid REMS website, and Welcome Letter.
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.
  3. Include new information regarding venous thromboembolic events and arterial thromboembolic events in REMS materials.
11/15/2013 Modified to:

  1. Add and implement a pharmacy portal to facilitate pharmacy activity within the REMS.
  2. Harmonize the REMS with the Thalomid (thalidomide) capsules and Pomalyst (pomalidomide) capsules REMS.
  3. Include the implementation of a survey of contraceptive use in females of reproductive potential and a survey of knowledge for pharmacists in the REMS assessment plan.
06/05/2013 Modified to incorporate the new indication for Revlimid (lenalidomide) capsules for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib, and to include a new 20 mg capsule.
02/08/2013 Modified to eliminate the requirement for the Medication Guide as an element of the REMSand harmonizing the REMS programs for Revlimid (lenalidomide) capsules and Thalomid (thalidomide).
05/09/2012 Modified to include information about the risk of second primary malignancies, the addition of the 2.5 mg dosage form, warning that Revlimid (lenalidomide) capsules is present in human semen, and notification of the presence of lactose in Revlimid (lenalidomide) capsules in the Medication Guide.
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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