Approved Risk Evaluation and Mitigation Strategies (REMS)

Lenalidomide

Shared System REMS

REMS last update: 03/24/2023

• Products
• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What medicines are included in the REMS?

Product Name	Application Number	Application Holder	Added to REMS	DailyMed Link	FDA Link
Revlimid (Lenalidomide) (Info at Drugs@FDA)	NDA 021880	BRISTOL MYERS SQUIBB	05/21/2021
lenalidomide (Info at Drugs@FDA)	ANDA 209348	DR REDDYS	08/30/2022
Lenalidomide (Info at Drugs@FDA)	ANDA 211022	APOTEX	08/30/2022
Lenalidomide (Info at Drugs@FDA)	ANDA 213912	MYLAN	08/30/2022
Lenalidomide (Info at Drugs@FDA)	ANDA 210480	LOTUS PHARM CO LTD	08/31/2022
Lenalidomide (Info at Drugs@FDA)	ANDA 210435	CIPLA	09/06/2022
Lenalidomide (Info at Drugs@FDA)	ANDA 210154	ZYDUS PHARMS	09/12/2022
Lenalidomide (Info at Drugs@FDA)	ANDA 211846	SUN PHARM	02/09/2023
Lenalidomide (Info at Drugs@FDA)	ANDA 213405	TORRENT	02/17/2023
Lenalidomide (Info at Drugs@FDA)	ANDA 214618	CIPLA	03/06/2023
Lenalidomide (Info at Drugs@FDA)	ANDA 213885	EUGIA PHARMA	03/06/2023
lenalidomide (Info at Drugs@FDA)	ANDA 212414	HETERO LABS LTD V	05/11/2023
lenalidomide (Info at Drugs@FDA)	ANDA 217265	QILU	02/22/2024
Lenalidomide (Info at Drugs@FDA)	ANDA 217281	NOVUGEN	09/11/2024
Lenalidomide (Info at Drugs@FDA)	ANDA 201452	ARROW INTL	05/21/2021

What is the purpose of the REMS?

The goals of the Lenalidomide REMS are as follows:

1. To prevent the risk of embryo-fetal exposure to lenalidomide.
2. 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.

View application holder(s) REMS Website

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. | Prescriber Enrollment Form | Review the following: Welcome Letter, Prescriber Guide, and REMS Education and Prescribing Safety Kit. | REMS Education and Prescribing Safety Kit | | Prescriber Guide | | 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 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. | 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. | Emergency Contraception Brochure | | Patient Guide | 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. | Emergency Contraception Brochure | | Patient Guide | 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 for Male Child | | Patient-Physician Agreement Form for Adult Male | | Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant | | Patient-Physician Agreement Form for Female Child Who Can Not Get Pregnant | | Patient-Physician Agreement Form for Female Child Who Can Get Pregnant | | Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant | 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. | Emergency Contraception Brochure | | Patient Guide | 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 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. | Patient Guide |
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 and the Emergency Contraception Brochure. | Emergency Contraception Brochure | | 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. | Patient-Physician Agreement Form for Female Child Who Can Get Pregnant | | Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant | 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. | Patient Guide |
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. | 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. | Patient-Physician Agreement Form for Adult Female Who Can Not Get Pregnant | 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. | 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. | 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 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 and the Emergency Contraception Brochure. | Emergency Contraception Brochure | | 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 theprescriber. Enrollment information will be provided to the REMS Program. | Patient-Physician Agreement Form for Male Child | | Patient-Physician Agreement Form for Adult Male | 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. | 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 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. | REMS Program Pharmacy Training | | Pharmacy Guide | | 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. | 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. | 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 lenalidomide and additional safe-use conditions using the Education and Counseling Checklist for Pharmacies. | 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. | Education and Counseling Checklist for Pharmacies | 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. | 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.

Material Name	Material Name Link
BMS REMS Patient Safety Website (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_BMS_REMS_Patient_Safety_Website.pdf
Education and Counseling Checklist for Pharmacies (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Education_and_Counseling_Checklist_for_Pharmacies.pdf
Emergency Contraception Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Emergency_Contraception_Brochure.pdf
Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient_Guide.pdf
Patient Resource Pack Envelope (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Patient_Resource_Pack_Envelope.pdf
Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_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/Lenalidomide_2023_03_24_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/Lenalidomide_2023_03_24_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/Lenalidomide_2023_03_24_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/Lenalidomide_2023_03_24_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/Lenalidomide_2023_03_24_Patient-Physician_Agreement_Form_for_Male_Child.pdf
Pharmacy Certification Quiz (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Pharmacy_Certification_Quiz.pdf
Pharmacy Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Pharmacy Guide.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Prescriber_Enrollment_Form.pdf
Prescriber Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Prescriber_Guide.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Document.pdf
REMS Education and Prescribing Safety Kit (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Education_and_Prescribing_Safety_Kit.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Full.pdf
REMS Program Pharmacy Training (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Program_Pharmacy_Training.pdf
REMS Program Website (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_REMS_Program_Website.pdf
Welcome Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lenalidomide_2023_03_24_Welcome_Letter.pdf

What assessment is available to the REMS?

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 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.