Approved Risk Evaluation and Mitigation Strategies (REMS)
Thalomid (thalidomide)
NDA #020785
REMS last update: 06/27/2017
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 |
|
Before treatment initiation |
|
During treatment; before each prescription |
|
After treatment discontinuation; for 12 consecutive months |
|
At all times |
|
Adult females of reproductive potential and female children of reproductive potential and/or their guardian who are prescribed Thalomid
Before the first prescription |
|
During treatment; before each prescription |
|
During treatment; every month |
|
During treatment |
|
After treatment discontinuation; for at least four weeks |
|
At all times |
|
Adult females not of reproductive potential who are prescribed Thalomid
Before the first prescription |
|
During treatment; before each prescription |
|
During treatment; every six months |
|
At all times |
|
Female children not of reproductive potential and/or their guardian who are prescribed Thalomid
Before the first prescription |
|
During treatment; before each prescription |
|
During treatment; every month |
|
At all times |
|
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 |
|
During treatment; before each prescription |
|
During treatment; every month |
|
During treatment |
|
After treatment discontinuation; for at least four weeks |
|
At all times |
|
Pharmacies that dispense Thalomid must
To become certified to dispense |
|
Before dispensing |
|
At all times |
|
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:
|
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:
|
09/12/2014 | Modified to:
|
11/15/2013 | Modified to:
|
02/08/2013 | Modified to:
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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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