Approved Risk Evaluation and Mitigation Strategies (REMS)

Thalomid (thalidomide)

NDA #020785

REMS last update: 06/27/2017

Goals
Summary
REMS Materials
Update history

What is the purpose of the REMS?

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

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

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 Thalomid must

To become certified to prescribe	Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS program. \| Prescriber Enrollment Form \|
Before treatment initiation	Counsel the patient on the benefits and risks of THALOMID therapy, including risks described in the BOXED WARNINGS. Counsel the patient on contraception and emergency contraception using the Patient Guide, Emergency Contraception Brochure, and Education and Safety Kit. \| Patient Guide to Thalomid REMS Program \| \| Emergency Contraception Brochure \| \| Thalomid REMS Program Education and Prescribing Safety Kit \| For a female of reproductive potential: assess the patient's pregnancy status by ordering and verifying a negative pregnancy test result. Complete a prescriber survey to obtain a prescription authorization number. Document the authorization number and the patient’s risk category on the prescription. Enroll the patient by completing and submitting the appropriate Patient-Physician Agreement Form to the REMS program. \| Patient-Physician Agreement Form for an Adult Male \| \| Patient-Physician Agreement Form for a Male Child \| \| Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant \| \| Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant \| \| Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant \| \| Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant \| Order the prescription using the appropriate Patient Prescription Form. \| Patient Prescription Form \| \| Patient Prescription Form - Veterans Health Administration (VHA) Only \| Prescribe no more than a 28 days’ supply. Do not prescribe refills or prescribe over the telephone.
During treatment; before each prescription	Counsel the patient contraception and emergency contraception using the Patient Guide, Emergency Contraception Brochure, and Education and Safety Kit. \| Patient Guide to Thalomid REMS Program \| \| Emergency Contraception Brochure \| \| Thalomid REMS Program Education and Prescribing Safety Kit \| For a female of reproductive potential: assess the patient's pregnancy status by ordering and verifying a negative pregnancy test result. Complete a prescriber survey to obtain a prescription authorization number. Document the authorization number on the prescription. Order the prescription using the appropriate Patient Prescription Form. \| Patient Prescription Form \| \| Patient Prescription Form - Veterans Health Administration (VHA) Only \| Prescribe no more than a 28 days’ supply. Do not prescribe refills or prescribe over the telephone.
After treatment discontinuation; for 12 consecutive months	Re-enroll the patient in the REMS by completing the appropriate Patient-Physician Agreement Form and submitting it to the REMS program. \| Patient-Physician Agreement Form for an Adult Male \| \| Patient-Physician Agreement Form for a Male Child \| \| Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant \| \| Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant \| \| Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant \| \| Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant \| Counsel the patient on the benefits and risks of THALOMID therapy, including risks described in the BOXED WARNINGS. Counsel the patient on contraception and emergency contraception using and providing Patient Guide, Emergency Contraception Brochure, and Education and Safety Kit. \| Patient Guide to Thalomid REMS Program \| \| Emergency Contraception Brochure \| \| Thalomid REMS Program Education and Prescribing Safety Kit \|
At all times	Report any pregnancies immediately to Celgene Customer Care. Return unused product from patients to Celgene Customer Care.

Adult females of reproductive potential and female children of reproductive potential and/or their guardian who are prescribed Thalomid

Before the first prescription	Review the Patient Guide, Emergency Contraception Brochure, Education and Safety Kit. \| Patient Guide to Thalomid REMS Program \| \| Emergency Contraception Brochure \| \| Thalomid REMS Program Education and Prescribing Safety Kit \| Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. \| Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant \| \| Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant \| Receive counseling from the prescriber on the benefits and risks of THALOMID therapy from the prescriber. Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist. Get a pregnancy test.
During treatment; before each prescription	Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist.Receive counseling from the prescriber on contraception and emergency contraception. Get a pregnancy test at an interval specified by the prescriber.
During treatment; every month	Complete a mandatory survey (phone or online).
During treatment	Adhere to the safe use conditions, including not taking if pregnant, breastfeeding a baby, or using contraception (unless continuously abstinent) as described in the Patient Guide and Patient-Physician Agreement Form. \| Patient-Physician Agreement Form for an Adult Male \| \| Patient-Physician Agreement Form for a Male Child \| \| Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant \| \| Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant \| \| Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant \| \| Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant \| \| Patient Guide to Thalomid REMS Program \|
After treatment discontinuation; for at least four weeks	Adhere to the safe use conditions, including refraining from becoming pregnant.
At all times	Inform the prescriber if they become pregnant, misses a menstrual period, experiences unusual menstrual bleeding, stops using contraception, or thinks for any reason that she may be pregnant. Return unused product to their prescriber or pharmacy.

Adult females not of reproductive potential who are prescribed Thalomid

Before the first prescription	Review the Patient Guide, Emergency Contraception Brochure, Education and Safety Kit. \| Patient Guide to Thalomid REMS Program \| \| Emergency Contraception Brochure \| \| Thalomid REMS Program Education and Prescribing Safety Kit \| Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. \| Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant \| Receive counseling from the prescriber on the benefits and risks of THALOMID therapy from the prescriber. Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist.
During treatment; before each prescription	Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist. Receive counseling from the pharmacist.
During treatment; every six months	Complete a mandatory survey (phone or online).
At all times	Return unused product to their prescriber or pharmacy.

Female children not of reproductive potential and/or their guardian who are prescribed Thalomid

Before the first prescription	Review the Patient Guide, Emergency Contraception Brochure, Education and Safety Kit. \| Patient Guide to Thalomid REMS Program \| \| Emergency Contraception Brochure \| \| Thalomid REMS Program Education and Prescribing Safety Kit \| Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. \| Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant \| Receive counseling from the prescriber on the benefits and risks of THALOMID therapy from the prescriber. Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist.
During treatment; before each prescription	Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist.
During treatment; every month	Complete a mandatory survey (phone or online).
At all times	Return unused product to their prescriber or pharmacy.

Adult males 18 years and older or male children 18 years and younger and/or their guardian who are prescribed Thalomid

Before the first prescription	Review the Patient Guide, Emergency Contraception Brochure, Education and Safety Kit. all times \| Patient Guide to Thalomid REMS Program \| \| Emergency Contraception Brochure \| \| Thalomid REMS Program Education and Prescribing Safety Kit \| Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. \| Patient-Physician Agreement Form for an Adult Male \| \| Patient-Physician Agreement Form for a Male Child \| Receive counseling from the prescriber on the benefits and risks of THALOMID therapy from the prescriber. Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist.
During treatment; before each prescription	Receive counseling from the prescriber on contraception and emergency contraception. Receive counseling from the pharmacist.
During treatment; every month	Complete a mandatory survey (phone or online).
During treatment	Adhere to the safe use conditions, including not having unprotected sexual contact with a female who can become pregnant and wearing a latex condom every time the patient has sexual contact while the male patient is receiving treatment, during dose interruptions, even if the patient has had a successful vasectomy. Do not donate sperm.
After treatment discontinuation; for at least four weeks	Adhere to the safe use conditions; including not having unprotected sexual contact with a female who can become pregnant and wearing a latex condom every time the patient has sexual contact, even if the patient has had a successful vasectomy. Do not donate sperm.
At all times	Inform the prescriber if the patient has unprotected sexual contact with a female who can become pregnant, or if they think for any reason that the male patient’s sexual partner might be pregnant. Return unused product to their prescriber or pharmacy.

Pharmacies that dispense Thalomid must

To become certified to dispense	Receive training provided by Celgene.
Before dispensing	Counsel the patient using the Education and Counseling Checklist for Pharmacies. \| Education and Counseling Checklist for Pharmacies \| Verify that a prescription authorization number is documented on the prescription. Obtain authorization to dispense by obtaining a confirmation number from the Celgene Customer Care Call Center or by using the Celgene REMS Pharmacy Portal. Document the confirmation number on the prescription. Dispense no more than a 28 day’s supply. Dispense a subsequent prescription only if there are 7 days or less remaining on the existing prescription. Do not dispense refills.
At all times	Return unused product from the patient or prescriber to the Celgene Customer Care. Do not distribute, transfer, loan, or sell product. Maintain records of each prescription dispensed and the corresponding completed Education and Counseling Checklist. \| Education and Counseling Checklist for Pharmacies \| Comply with audits carried out by the Celgene 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. For a specific Medication Guide of a product in the Thalomid REMS, see the DailyMed link(s).

Material Name	Material Name Link
Celgene REMS Programs Pharmacy Training: the Thalomid REMS Program (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Celgene_REMS_Programs_Pharmacy_Training.pdf
Celgene Risk Management Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Celgene_Risk_Management_Website_Screenshots.pdf
Education and Counseling Checklist for Pharmacies (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Education_and_Counseling_Checklist_for_Pharmacies.pdf
Emergency Contraception Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Emergency_Contraception_Brochure.pdf
Patient Guide to Thalomid REMS Program (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Guide.pdf
Patient Prescription Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Prescription_Form.pdf
Patient Prescription Form - Veterans Health Administration (VHA) Only (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Prescription_Form_VHA_Only.pdf
Patient Survey Reminder Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Survey_Reminder_Card.pdf
Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Female_Child_Who_Can_Get_Pregnant.pdf
Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Female_Child_Who_Can_Not_Get_Pregnant.pdf
Patient-Physician Agreement Form for a Male Child (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Male_Child.pdf
Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Adult_Female_Who_Can_Get_Pregnant.pdf
Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Adult_Female_Who_Can_Not_Get_Pregnant.pdf
Patient-Physician Agreement Form for an Adult Male (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_PPAF_Adult_Male.pdf
Pharmacy Certification Quiz (the Thalomid REMS Program) (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Pharmacy_Certification_Quiz.pdf
Pharmacy Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Pharmacy_Guide.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Prescriber_Enrollment_Form.pdf
Prescriber Guide to Thalomid REMS (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Prescriber_Guide.pdf
REMS document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_REMS_Document.pdf
REMS full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Full.pdf
Thalomid REMS At-A-Glance (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_At_A_Glance.pdf
Thalomid REMS Patient Resource Pack Envelope (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Patient_Resource_Pack_Envelope.pdf
Thalomid REMS Program Education and Prescribing Safety Kit (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Education_and_Prescribing_Safety_Kit.pdf
Welcome Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Thalomid_2017-06-27_Welcome_Letter.pdf

What updates have been made to the REMS?

Date	Summary of change
06/27/2017	Modified to: Remove reference to the previous REMS program names. Remove the CD-ROM/desktop software as a method to enroll patients into the REMS. Add clarifying language regarding contraception use requirements for contraception use by patients enrolled in the REMS. Update the name of the Veterans Health Administration in the REMS document and the material. Add a tear-off quick reference guide for prescribers in the REMS at a Glance appended material. Add REMS contraception information for patients to be used by non-prescribing healthcare providers. Add an updated brochure regarding emergency contraception.
06/09/2017	Modified to remove reference to the previous names of the REMS from REMS documents, remove the CD-ROM/desktop software as avenues to enroll patients into the REMS, add clarifying language regarding contraception use within the REMS, update the name of the Veterans Health Administration, add a tear-off quick reference guide for prescribers, add a REMS contraception information piece for patients to use with non-prescribing healthcare providers, introduce a revised protocol for obtaining pregnancy exposure information within the pregnancy registry, remove language related to the launch of the REMS mobile app from the REMS Supporting Document, remove reference from the REMS Supporting Document to an informational webinar that occurred in the past, include language in the REMS Supporting Document regarding the assessment that must accompany efficacy supplements, and include an updated brochure regarding emergency contraception to the approved risk evaluation and mitigation strategy (REMS).
04/22/2016	Modified to change the contact information for emergency contraception information, add flow charts to the Prescriber Guide and the Patient Guide for clarity, add clarifying language to the prescriber enrollment forms about the authorization number, add unacceptable forms of birth control to the Education and Counseling Checklist and Patient Prescriber Agreement Forms (PPAFs), replace “doctor” with “healthcare provider” throughout the PPAF, change the trademark symbols to registered trademark symbols, and insert a “Forgot Password” screenshot in the Celgene Risk Management Website User Guide.
12/01/2015	Modified to add links to Spanish language REMS materials to the REMS website, add additional links from CelgeneRiskManagement.com to the individual product REMS websites, add functionality to the Prescriber Calendar, Review Authorization, and Reports in the prescriber portal in CelgeneRiskManagement.com.
10/27/2015	Modified to remove the ICD-10 code from the Patient Prescription Forms (General Patient Prescription Form and Veterans Administration Patient Prescription Form).
09/13/2015	Modified to: Include a mobile applications to provide an additional platform to accomplish internet-capable REMS activities in the REMS materials. Revise a timetable for submission of assessments.
09/12/2014	Modified to: Remove the “Rules for Dispensing” section in the Education and Counseling Checklist for Pharmacies. Update the current International Statistical Classification of Diseases and Related Health Problems (ICD) classifications in the Patient Prescription Forms.
11/15/2013	Modified to: Harmonize the REMS with Revlimid (lenalidomide), and Pomalyst (pomalidomide) capsules. Add and implement a pharmacy portal to facilitate pharmacy activity within the REMS. Dispense Thalomid (thalidomide) through certified pharmacies Harmonize the training that pharmacists receive to dispense Thalomid (thalidomide) capsules with the training pharmacists receive for Revlimid (lenalidomide) and Pomalyst (pomalidomide) capsules.
02/08/2013	Modified to: Eliminate the requirement for the Medication Guide as an element of the REMS. Harmonize the REMS programs for Revlimid (lenalidomide) capsules and Thalomid (thalidomide) capsules.
08/03/2010	Approval of the REMS.

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

Thalomid (thalidomide) NDA #020785 REMS last update: 06/27/2017