Approved Risk Evaluation and Mitigation Strategies (REMS)

Pomalidomide
Shared System REMS
REMS last update: 10/30/2020

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Pomalidomide (Info at Drugs@FDA) ANDA 210249 EUGIA PHARMA 10/30/2020
Pomalidomide (Info at Drugs@FDA) ANDA 210111 BRECKENRIDGE 10/30/2020

What is the purpose of the REMS?

The goals of the Pomalidomide REMS are as follows:

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

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 See Disclaimer page regarding links to external sites

Healthcare providers who prescribe pomalidomide must:

To become certified to prescribe
  • Review the drug's Prescribing Information.
  • Enroll into the Pomalidomide REMS by completing the Prescriber Enrollment Form and submitting it to the Pomalidomide REMS.
  • Review the following: Welcome Letter, Prescriber Guide, and REMS Education and Prescribing Safety Kit. | 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: Asses the patient's pregnancy status by ordering and confirming a negative test result. Document and submit the results to the REMS Program.
Before treatment intiation (first prescription)
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 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 parters of male patients immediately to the Pomalidomide REMS.
  • Return all unused product from patients to the Pomalidomide REMS.

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

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 your prescriber.
Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of pomalidomide 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 Pomalidomide 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 Pomalidomide REMS. | Patient Physician Agreement Form Adult Female Who Can Get Pregnant | | Patient Physician Agreement Form Female Child Who Can Get Pregnant |
  • Complete the patient survey.
  • Receive counseling from the pharmacy on the benefits and risks of pomalidomide; not sharing pomalidomide; not donating blood; not breaking, chewing, or opening pomalidomide capsules; instructions on dose and administration; reading the Pomalidomide REMS education materials; and being compliant with the REMS requirements.
  • Receive counseilng from the pharmacy on the embryo-fetal toxicity with exposure to pomalidomide; contraception requirements; pregnancy testing requirement; not taking pomalidomide if pregnant, breastfeeding, and not using contraception; and to immediately stop taking pomalidomide and notify the prescriber if pregnant or suspect you 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 pomalidomide, not sharing pomalidomide, not donating blood, not breaking, chewing or opening pomalidomide capsules, instructions on dose and administration, reading the Pomalidomide REMS education materials, and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryo-fetal toxicity with exposure to pomalidomide; contraception requirements; pregnancy testing requirements; not taking pomalidomide if pregnant, breastfeeding or not using contraception; and to immediately stop taking pomalidomide and notify the prescriber if pregnant or suspect you may be pregnant.
  • Complete 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 pomalidomide if pregnant, breastfeeding, or not using contraception; 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 pomalidomide immediately.
  • Return unused pomalidomide to the Pomalidomide REMS, your prescriber, or the pharmacy that dispensed the pomalidomide.
  • Adhere to safe-use conditions: Not sharing pomalidomide, not breakin, chewing, or opening pomalidomide capsules, and keeping pomalidomide out of reach of children.

Adult females who cannot get pregnant who are prescribed pomalidomide:

Before treatment intiation
  • Receive counseling from the prescriber on the benefits and risks of pomalidomide and the need to complete the patient survey.
  • Review the Patient Guide. | Patient Guide |
  • Complete patient survey.
  • Enroll into the Pomalidomide REMS by completing a Patient Physician Agreement Form for Adult Female Who Cannot Get Pregnant with the prescriber. Enrollment information will be provided to the Pomalidomide REMS. | Patient Physician Agreement Form Adult Females Who Cannot Get Pregnant |
  • Receive counseling from the pharmacy on the benefits and risks of pomalidomide therapy; not sharing pomalidomide, not donating blood; not breaking, chewing, or opening pomalidomide capsules; instructions on dose and administration; reading the Pomalidomide 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 pomalidomide therapy; not sharing pomalidomide; not donating blood; not breaking, chewing, or opening pomalidomide capsules; instructions on dose and administration; reading the Pomalidomide 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 pomalidomide to the Pomalidomide REMS, their prescriber, or the pharmacy that dispensed their pomalidomide.
  • Adhere to the safe-use conditions: Not sharing pomalidomide; not breaking, chewing, or opening pomalidomide capsules; and keeping pomalidomide out of reach of children.

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

Before treatment intiation
  • Receive counseling from the prescriber on the benefits and risks of pomalidomide and the prescriber need to complete the patient survey.
  • Review the Patient Guide. | Patient Guide |
  • Enroll into the Pomalidomide 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 Pomalidomide REMS. | Patient Physician Agreement Form Female Child Who Cannot Get Pregnant |
  • Complete the patient survey.
  • Receive counseling from the pharmacy on the benefits and risks of pomalidomide; not sharing pomalidomide, not donating blood; not breaking, chewing, or opening pomalidomide capsules; instructions on dose and administration; reading the Pomalidomide REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy to inform their pomalidomide 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 pomalidomide, not sharing pomalidomide; not donating blood; not breaking, chewing, or opening pomalidomide capsules; instructions on dose and administration; reading the Pomalidomide REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy to inform their pomalidomide prescriber when the patient begins 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.
  • Return unused pomalidomide to the Pomalidomide REMS, their prescriber, or the pharmacy that dispensed their pomalidomide.
  • Adhere to safe-use conditions: Not sharing pomalidomide; not breaking, chewing, or opening pomalidomide capsules; and keeping pomalidomide out of reach of children.

Males (adults and children) who are prescribed pomalidomide:

Before treatment initiation
  • Receive counseling from the prescriber on the benefits and risks of pomalidomide, 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 Pomalidomide 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 Pomalidomide REMS. | Patient Physician Agreement Form Male Child | | Patient Physician Agreement Form Adult Male |
  • Receive counseling from the pharmacy on the benefits and risks of pomalidomide; not sharing pomalidomide; not donating blood; not breaking, chewing, or opening pomalidomide capsules; instructions on dose and administration; reading the Pomalidomide REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on embryo-fetal toxicity with exposure to pomalidomide, 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 pomalidomide; not sharing pomalidomide; not donating blood; not breaking, chewing, or opening pomalidomide capsules; instructions on dose and administration; reading the Pomalidomide REMS education materials; and being compliant with the REMS requirements.
  • Receive counseling from the pharmacy on the embryo-fetal toxicity with exposure to pomalidomide, 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 pomalidomide to the Pomalidomide REMS, their prescriber, or the pharmacy that dispensed their pomalidomide.
  • Adhere to safe-use conditions: Not sharing pomalidomide; not breaking, chewing, or opening pomalidomide capsules; and keeping pomalidomide out of reach of children.

Pharmacies that dispense pomalidomide:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS program on behalf of the pharmacy.
  • Have the authorized representative review the following: Pharmacy Guide, Pharmacy Training, Prescribing Information. | Pharmacy Training | | Pharmacy Guide |
  • Have the authorized representative enroll in the Pomalidomide REMS by completing the Pharmacy Enrollment Form and submitting it to the Pomalidomide REMS. | Pharmacy Enrollment Form |
  • Have the authorized representative complete the Pharmacy Certification Quiz and submit it to the REMS program. | Pharmacy Certification Quiz |
  • Train all relevant staff involved in counseling and dispensing pomalidomide on the Pomalidomide REMS requirements using the REMS Pharmacy Training. | Pharmacy Training |
  • Establish processes and procedures to identify new staff involved in counseling and dispensing pomalidomide 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 pomalidomide, and safe-use requirements using the Education and Counseling Checklist for Pharmacies. | Education and Counseling Checklist for Pharmacies |
  • For females (adults and children) who can get pregant, counsel on the embryo-fetal toxicity with exposure to pomalidomide 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 mense begins using the Education and Counseling Checklist for Pharmacies. | Education and Counseling Checklist for Pharmacies |
  • For males (adults and children): Counsel the patient on the embryo-fetal toxicity with exposure to pomalidomide 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 program.
  • Obtain a 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 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.
  • 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 pomalidomide 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 Pomalidomide REMS by successfully completing the Pharmacy Certification Quiz and Pharmacy Enrollment Form and submitting both to the Pomalidomide REMS. | Pharmacy Certification Quiz | | Pharmacy Enrollment Form |
At all times
  • Report pregnancies immediately to the Pomalidomide REMS.
  • Do not distribute, transfer, loan, or sell pomalidomide, except with the permission of the Pomalidomide 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 Pomalidomide 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 Pomalidomide REMS.

Wholesalers-distributors that distribute pomalidomide:

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 Program requirements.
At all times
  • Distribute only to certified pharmacies.
  • Maintain records of distributions.
  • Comply with audits carried out by the Pomalidomide 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
Education and Counseling Checklist for Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Education_and_Counseling_Checklist_for_Pharmacies.pdf
Education and Prescribing Safety Kit (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Education_and_Prescribing_Safety_Kit.pdf
Emergency Contraception Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Emergency_Contraception_Brochure.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Guide.pdf
Patient Physician Agreement Form Adult Female Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Adult_Female_Who_Can_Get_Pregnant.pdf
Patient Physician Agreement Form Adult Females Who Cannot Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Adult_Females_Who_Cannot_Get_Pregnant.pdf
Patient Physician Agreement Form Adult Male (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Adult_Male.pdf
Patient Physician Agreement Form Female Child Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Female_Child_Who_Can_Get_Pregnant.pdf
Patient Physician Agreement Form Female Child Who Cannot Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Female_Child_Who_Cannot_Get_Pregnant.pdf
Patient Physician Agreement Form Male Child (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Physician_Agreement_Form_Male_Child.pdf
Patient Resources Pack Envelope (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Patient_Resource_Pack_Envelope.pdf
Pharmacy Certification Quiz (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Certification_Quiz.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Enrollment_Form.pdf
Pharmacy Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Guide.pdf
Pharmacy Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Pharmacy_Training.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Prescriber_Enrollment_Form.pdf
Prescriber Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Prescriber_Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_REMS_Program_Website_Screenshots.pdf
Welcome Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Pomalidomide_2020_10_30_Welcome_Letter.pdf

What updates have been made to the REMS?

Date Summary of change
10/30/2020 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.

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