Approved Risk Evaluation and Mitigation Strategies (REMS)

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Thalomid (thalidomide)

NDA #020785

REMS last update: 06/27/2017

View the Thalomid Prescribing Information and Medication Guide at DailyMed.
View Thalomid's Regulatory Information at Drugs@FDA

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.
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. 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. Order the prescription using the appropriate Patient Prescription Form. 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. 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. 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. 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.
At all times	Report any pregnancies immediately to Celgene Customer Care. Return unused product from patients to Celgene Customer Care.

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. 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.Dispense no more than a 28 day’s supply. 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. Comply with audits carried out by the Celgene to ensure that all processes and procedures are in place and are being followed.

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. Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. 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.
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. Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. 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. Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. 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 Enroll into the REMS Program by completing the Patient-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS program. 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.

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:

Select to View Firm Press Release Download This List

Material Name
Celgene REMS Programs Pharmacy Training: the Thalomid REMS Program (PDF)
Celgene Risk Management Website Screenshots (PDF)
Education and Counseling Checklist for Pharmacies (PDF)
Emergency Contraception Brochure (PDF)
Patient Guide to Thalomid REMS Program (PDF)
Patient Prescription Form (PDF)
Patient Prescription Form - Veterans Health Administration (VHA) Only (PDF)
Patient Survey Reminder Card (PDF)
Patient-Physician Agreement Form for a Female Child Who Can Get Pregnant (PDF)
Patient-Physician Agreement Form for a Female Child Who Can Not Get Pregnant (PDF)
Patient-Physician Agreement Form for a Male Child (PDF)
Patient-Physician Agreement Form for an Adult Female Who Can Get Pregnant (PDF)
Patient-Physician Agreement Form for an Adult Female Who Can Not Get Pregnant (PDF)
Patient-Physician Agreement Form for an Adult Male (PDF)
Pharmacy Certification Quiz (the Thalomid REMS Program) (PDF)
Pharmacy Guide (PDF)
Prescriber Enrollment Form (PDF)
Prescriber Guide to Thalomid REMS (PDF)
REMS document (PDF)
REMS full (PDF)
Thalomid REMS At-A-Glance (PDF)
Thalomid REMS Patient Resource Pack Envelope (PDF)
Thalomid REMS Program Education and Prescribing Safety Kit (PDF)
Welcome Letter (PDF)

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