Approved Risk Evaluation and Mitigation Strategies (REMS)

Thalidomide

Shared System REMS

REMS last update: 04/27/2023

• 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
thalidomide (Info at Drugs@FDA)	ANDA 213267	NATCO	04/27/2023

What is the purpose of the REMS?

The goals of the Thalidomide REMS are as follows:

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

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website

Healthcare providers who prescribe thalidomide must:

To become certified to prescribe	Review the drug’s Prescribing Information. Enroll into the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS. | Prescriber Enrollment Form | Review the following: Welcome Letter, Prescriber Guide, and REMS Education and Prescribing Safety Kit. | Welcome Letter | | Prescriber Guide | | 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 test result. Document and submit the results to the REMS.
Before treatment initiation (first prescription)	For all patients: Counsel the patient on the benefits and risks of thalidomide therapy, including risks described in the Boxed WARNINGS and the need to complete mandatory patient surveys using the Patient Guide and Patient-Physician Agreement Form. Provide a copy of the materials to the patient. | Patient Guide | For females (adults and children) who can get pregnant: Counsel the patient on contraception requirements and emergency contraception using the Patient Guide and the Emergency Contraception Brochure. Provide a copy of the materials to the patient. | Patient Guide | | Emergency Contraception Brochure | For males (adults and children): Counsel the patient on the barrier contraception requirements and emergency contraception using the Patient Guide and the Emergency Contraception Brochure. Provide a copy of the materials to the patient. | Patient Guide | | Emergency Contraception Brochure | Enroll the patient by completing and submitting the Patient-Physician Agreement Form for Female Child Who Can Get Pregnant, Patient-Physician Agreement Form for Female Child Who Cannot Get Pregnant, Patient-Physician Agreement Form for Male Child, Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant, Patient-Physician Agreement Form for Adult Female Who Cannot Get Pregnant, or Patient-Physician Agreement Form for Adult Male to the Thalidomide REMS. | Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant | | Patient-Physician Agreement Form for Female Child Who Can Get Pregnant | | Patient-Physician Agreement Form for Adult Female Who Cannot Get Pregnant | | Patient-Physician Agreement Form for Female Child Who Cannot Get Pregnant | | Patient-Physician Agreement Form for Adult Male | | Patient-Physician Agreement Form for Male Child | Obtain authorization by contacting the REMS to complete the prescriber survey to verify the patient’s reproductive status, negative pregnancy test status, and completion of counseling. Document the prescription authorization number and the patient’s risk category on the prescription. Prescribe no more than a 28 days’ supply. Not prescribe refills or prescribe over the phone.
During treatment; weekly for at least the first 4 weeks	For females (adults and children) who can get pregnant: Assess the patient's pregnancy status by ordering and reviewing the results of her pregnancy test.
During treatment; every 2 weeks after the first 4 weeks	For females (adults and children) with irregular menstrual cycles who can get pregnant: Assess the patient's pregnancy status by ordering and reviewing the results of her pregnancy test.
During treatment; every 4 weeks after the first 4 weeks	For females (adults and children) with regular menstrual cycles who can get pregnant: Assess the patient's pregnancy status by ordering and reviewing the results of her pregnancy test. Document and submit the results to the REMS.
During treatment: before each prescription	For all patients: Counsel the patient on the need to complete the patient survey. For females (adults and children) who can get pregnant: Counsel the patient on contraception requirements and emergency contraception using the Patient Guide and the Emergency Contraception Brochure. | Patient Guide | | Emergency Contraception Brochure | For males (adults and children): Counsel the patient on the barrier contraception requirements using the Patient Guide. | Patient Guide | Obtain authorization by contacting the REMS to complete the prescriber survey to verify the patient’s reproductive status, negative pregnancy test status, and completion of counseling. Document the prescription authorization number and the patient’s risk category on the prescription. Prescribe no more than a 28 days’ supply. Not prescribe refills or prescribe over the phone.
At all times	Report any pregnancies in female patients or female partners of male patients immediately to the REMS. .Return all unused product from patients to the Thalidomide REMS

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

Before treatment initiation; 4 weeks	Adhere to the safe use conditions: using contraception and not getting pregnant as described in the Patient Guide and the Patient-Physician Agreement Form.
Before treatment initiation; within 10-14 days and again within 24 hours	Get a pregnancy test as directed by your prescriber.
Before treatment initiation	Receive counseling from the prescriber on the benefits and risks of thalidomide therapy and the need to complete the patient survey, on contraception requirements and emergency contraception. Review the Patient Guide and the Emergency Contraception Brochure. Enroll into the REMS by completing the Patient-Physician Agreement Form for Adult Female Who Can Get Pregnant or Patient-Physician Agreement Form for Female Child Who Can Get Pregnant with the prescriber. Enrollment information will be provided to the REMS. Complete the patient survey. Receive counseling from the pharmacy on the benefits and risks of thalidomide; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements. Receive counseling from the pharmacy on the embryo-fetal toxicity with exposure to thalidomide; contraception requirements; pregnancy testing requirement; not taking thalidomide if pregnant, breastfeeding, or not using contraception; and to immediately stop taking thalidomide and notify the prescriber if pregnant or suspect they may be pregnant.
During treatment; weekly for at least the first 4 weeks	Get a pregnancy test as directed by your prescriber.
During treatment; before each prescription	Receive counseling from the prescriber on contraception requirements and emergency contraception and the need to complete the patient survey. Get a pregnancy test as directed by your prescriber. Receive counseling from the pharmacy on the benefits and risks of thalidomide; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements. Receive counseling from the pharmacy on embryo-fetal toxicity with exposure to thalidomide; contraception requirements; pregnancy testing requirements; not taking thalidomide if pregnant, breastfeeding or not using contraception; and to immediately stop taking thalidomide and notify the prescriber if pregnant or suspect they may be pregnant. Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks	Adhere to the safe-use conditions: Not donating blood. Adhere to the safe-use conditions: Using contraception as described in the Patient Guide and the Patient-Physician Agreement Form; not taking thalidomide if pregnant, breastfeeding, or not using contraception; and not getting pregnant.
At all times	Inform the prescriber if pregnant, miss a menstrual period, experience unusual menstrual bleeding, stop using contraception, or think for any reason that they may be pregnant. Stop taking thalidomide immediately. Return unused thalidomide to the Thalidomide REMS, prescriber, or the pharmacy that dispensed the thalidomide. Adhere to safe-use conditions: Not sharing thalidomide; not breaking, chewing, or opening thalidomide capsules; and keeping thalidomide out of reach of children.

Adult females who cannot get pregnant who are prescribed thalidomide:

Before treatment initiation	Receive counseling from the prescriber on the benefits and risks of thalidomide and the need to complete the patient survey. Review the Patient Guide. Complete the patient survey. Enroll into the REMS by completing the Patient-Physician Agreement Form for Adult Female Who Cannot Get Pregnant with the prescriber. Enrollment information will be provided to the REMS. | Patient-Physician Agreement Form for Adult Female Who Cannot Get Pregnant | Receive counseling from the pharmacy on the benefits and risks of thalidomide therapy; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements.
During treatment; before each prescription	Receive counseling from the pharmacy on the benefits and risks of thalidomide therapy; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements.
During treatment; every 6 months	Receive counseling from the prescriber on the need to complete the patient survey. Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks	Adhere to the safe-use conditions: Not donating blood.
At all times	Return unused thalidomide to the Thalidomide REMS, prescriber, or the pharmacy that dispensed the thalidomide. Adhere to the safe-use conditions: Not sharing thalidomide; not breaking, chewing, or opening thalidomide capsules; and keeping thalidomide out of reach of children.

Female children who cannot get pregnant and who are prescribed thalidomide:

Before treatment initiation	Receive counseling from the prescriber on the benefits and risks of thalidomide and the need to complete the patient survey. Review the Patient Guide. Enroll into the Thalidomide REMS by completing the Patient-Physician Agreement Form for Female Child Who Cannot Get Pregnant with the prescriber. Enrollment information will be provided to the REMS | Patient-Physician Agreement Form for Female Child Who Cannot Get Pregnant | Complete the patient survey. Receive counseling from the pharmacy on the benefits and risks of thalidomide; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements. Receive counseling from the pharmacy to inform the thalidomide prescriber when the patient begins menses.
During treatment; before each prescription	Receive counseling from the prescriber on the need to complete the patient survey. Receive counseling from the pharmacy on the benefits and risks of thalidomide; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements. Receive counseling from the pharmacy to inform the thalidomide prescriber when the patient begin menses. Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks	Adhere to the safe-use conditions: Not donating blood.
At all times	Inform the prescriber when the patient begins menses. 13.Return unused thalidomide to the Thalidomide REMS, the prescriber, or the pharmacy that dispensed the thalidomide. .Adhere to safe-use conditions: Not sharing thalidomide; not breaking, chewing, or opening thalidomide capsules; and keeping thalidomide out of reach of children.

Males (adults and children) who are prescribed thalidomide:

Before treatment initiation	Receive counseling from the prescriber on the benefits and risks of thalidomide, the need to complete the patient survey, barrier contraception requirements, and emergency contraception. Review the Patient Guide and the Emergency Contraception Brochure. | Patient Guide | | Emergency Contraception Brochure | Enroll into the Thalidomide REMS 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. | Patient-Physician Agreement Form for Adult Male | | Patient-Physician Agreement Form for Male Child | Receive counseling from the pharmacy on the benefits and risks of thalidomide; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements. Receive counseling from the pharmacy on embryo-fetal toxicity with exposure to thalidomide; barrier contraception requirements; and not donating sperm.
During treatment; before each prescription	Receive counseling from the prescriber on barrier contraception requirements and emergency contraception, and the need to complete the patient survey. Receive counseling from the pharmacy on the benefits and risks of thalidomide; not sharing thalidomide; not donating blood; not breaking, chewing, or opening thalidomide capsules; instructions on dose and administration; reading the Thalidomide REMS education materials; and being compliant with the REMS requirements. Receive counseling from the pharmacy on the embryo-fetal toxicity with exposure to thalidomide; barrier contraception requirements; and not donating sperm. Complete the patient survey.
During treatment and after treatment discontinuation; for 4 weeks	Adhere to the safe-use conditions: Using barrier contraception as described in the Patient Guide and Patient-Physician Agreement Form. | Patient Guide | Adhere to the safe-use conditions: Not donating blood or sperm.
At all times	Inform the prescriber about unprotected sexual contact with a female who can become pregnant, or about a sexual partner who might be pregnant. Return unused thalidomide to the Thalidomide REMS, the prescriber, or the pharmacy that dispensed the thalidomide. Adhere to safe-use conditions: Not sharing thalidomide; not breaking, chewing, or opening thalidomide capsules; and keeping thalidomide out of reach of children.

Pharmacies that dispense thalidomide must:

To become certified to dispense	Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the Pharmacy. Have the authorized representative review the following: Pharmacy Guide, Pharmacy Training, and Prescribing Information. | Pharmacy Guide | | Pharmacy Training | Have the authorized representative enroll in the Thalidomide REMS by completing the Pharmacy Enrollment Form and submitting it to the Thalidomide REMS. Have the authorized representative complete the Pharmacy Certification Quiz and submit it to the REMS. | Pharmacy Certification Quiz | Train all relevant staff involved in counseling and dispensing thalidomide on the Thalidomide REMS requirements using the Pharmacy Training. | Pharmacy Training | Establish processes and procedures to identify new staff involved in counseling and dispensing thalidomide and ensure they are trained. Establish processes and procedures to verify there are 7 days or less remaining on the patient’s existing prescription, no more than 28 days’ supply is dispensed, and the prescriber provided the authorization number and patient risk category on the prescription.
Before dispensing	For all patients: Counsel the patient on the benefits and risks of thalidomide and safe-use requirements using the Education and Counseling Checklist for Pharmacies. | Education and Counseling Checklist for Pharmacies | For females (adult and children) who can get pregnant: Counsel on the embryo-fetal toxicity with exposure to thalidomide and her safe-use conditions using the Education and Counseling Checklist for Pharmacies. | Education and Counseling Checklist for Pharmacies | For female children who cannot get pregnant: Counsel the patient to inform the prescriber when menses begins using the Education and Counseling Checklist for Pharmacies. | Education and Counseling Checklist for Pharmacies | For males (adult and children): Counsel the patient on the embryo-fetal toxicity with exposure to thalidomide and additional safe-use requirements using the Education and Counseling Checklist for Pharmacies. | Education and Counseling Checklist for Pharmacies | Verify that a prescription authorization number and patient risk category are documented on each prescription through the processes and procedures established as a requirement of the REMS. Obtain a confirmation number to dispense each prescription by contacting the REMS to verify the prescriber is certified, the patient is enrolled and is not pregnant, and the authorization number is valid Document the confirmation number and the date it was obtained on the prescription. 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 it must be picked up within 24 hours of obtaining the confirmation number. For females (adult and children) who can get pregnant, ship thalidomide the same day the confirmation number is obtained or it must be picked up within 24 hours of obtaining the confirmation number.
To maintain certification to dispense	Have any new authorized representative enroll in the Thalidomide REMS by successfully completing the Pharmacy Certification Quiz and Pharmacy Enrollment Form and submitting both to the Thalidomide REMS. | Pharmacy Enrollment Form | | Pharmacy Certification Quiz |
At all times	Report pregnancies immediately to the Thalidomide REMS. Do not distribute, transfer, loan, or sell thalidomide, except with the permission of the REMS. Maintain records of each prescription dispensed with the corresponding confirmation number, date it was obtained, and completed Education and Counseling Checklist for Pharmacies. | Education and Counseling Checklist for Pharmacies | Comply with audits carried out by the Thalidomide REMS to ensure that all processes and procedures are in place and are being followed. Accept unused product from the patient or the prescriber. Return unused product from the patient or the prescriber to the Thalidomide REMS.

Wholesalers-distributors that distribute thalidomide must:

To be able to distribute	Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies. Train all relevant staff involved in distributing on the REMS requirements.
At all times	Distribute only to certified pharmacies. Maintain records of distributions. Comply with audits carried out by the Thalidomide REMS to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers.

Material Name	Material Name Link
Patient-Physician Agreement Form for Male Child (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Male_Child.pdf
Prescriber Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Prescriber_Guide.pdf
Education and Counseling Checklist for Pharmacies (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Education_and_Counseling_Checklist_for_Pharmacies.pdf
Emergency Contraception Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Emergency_Contraception_Brochure.pdf
Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Guide.pdf
Patient Resource Pack Envelope (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_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/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Can_Get_Pregnant.pdf
Patient-Physician Agreement Form for Adult Female Who Cannot Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Adult_Female_Who_Cannot_Get_Pregnant.pdf
Patient-Physician Agreement Form for Adult Male (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_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/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Female_Child_Who_Can_Get_Pregnant.pdf
Patient-Physician Agreement Form for Female Child Who Cannot Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Patient_Physician_Agreement_Form_for_Female_Child_Who_Cannot_Get_Pregnant.pdf
Pharmacy Certification Quiz (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Certification_Quiz.pdf
Pharmacy Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Enrollment_Form.pdf
Pharmacy Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Guide.pdf
Pharmacy Training (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Pharmacy_Training.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Prescriber_Enrollment_Form.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/ Thalidomide_2023_04_27_REMS_Document.pdf
REMS Education and Prescribing Safety Kit (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_REMS_Education_and_Prescribing_Safety_Kit.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_REMS_Website_Screenshots.pdf
Welcome Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalidomide_2023_04_27_Welocme_Letter.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date	Summary of change
04/27/2023	Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.