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The goals of the POMALYST risk evaluation and mitigation strategy are as follows:
To prevent the risk of embryo-fetal exposure to POMALYST.
To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.
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.
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 pregnancy
test result. Document and submit the result to the
REMS Program.
Before treatment initiation
(first prescription)
For all patients: Counsel the patient on the
benefits and risks of POMALYST therapy, including
risks described in the Boxed Warning and the need
to complete mandatory patient surveys using the
Patient Guide and Patient-Physician Agreement Form (PPAF). 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.
| Emergency Contraception Brochure |
| Patient Guide |
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.
| Emergency Contraception Brochure |
| 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.
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 using
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.
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 partners of male patients immediately to
the REMS Program.
Return all unused product from patients to the
POMALYST REMS.
Females (adults and children) who can get pregnant who are prescribed
POMALYST:
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 the
prescriber.
Before treatment initiation
Receive counseling from the prescriber on the
benefits and risks of POMALYST therapy and the
need to complete the patient survey, on
contraception requirements and emergency
contraception.
Receive counseling from the pharmacy on the
benefits and risks of POMALYST; not sharing
POMALYST; not donating blood; not breaking,
chewing, or opening POMALYST capsules;
instructions on dose and administration; reading
the POMALYST REMS education materials; and
being compliant with the REMS requirements.
Receive counseling from the pharmacy on the
embryo-fetal toxicity with exposure to POMALYST;
contraception requirements; pregnancy testing
requirement; not taking POMALYST if pregnant,
breastfeeding, or not using contraception; and to
immediately stop taking POMALYST and notify the
prescriber if pregnant or suspect you may be
pregnant.
During treatment; weekly at
least the first 4 weeks
Get a pregnancy test as directed by the
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 the
prescriber.
Receive counseling from the pharmacy on the
benefits and risks of POMALYST; not sharing
POMALYST; not donating blood; not breaking,
chewing, or opening POMALYST capsules;
instructions on dose and administration; reading
the POMALYST REMS education materials; and
being compliant with the REMS requirements.
Receive counseling from the pharmacy on
embryo-fetal toxicity with exposure to POMALYST;
contraception requirements; pregnancy testing
requirement; not taking POMALYST if pregnant,
breastfeeding or not using contraception; and to
immediately stop taking POMALYST and notify the
prescriber if pregnant or suspect you 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 POMALYST if pregnant, breastfeeding, or
not using contraception; and 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
POMALYST immediately.
Return unused POMALYST to the POMALYST
REMS, the prescriber, or the pharmacy that
dispensed the POMALYST.
Adhere to safe-use conditions: Not sharing
POMALYST; not breaking, chewing, or opening
POMALYST capsules; and keeping POMALYST out
of reach of children.
Adult females who cannot get pregnant who are prescribed POMALYST:
Before treatment initiation
Receive counseling from the prescriber on the
benefits and risks of POMALYST and the need to
complete the patient survey.
Receive counseling from the pharmacy on the
benefits and risks of POMALYST therapy; not
sharing POMALYST; not donating blood; not
breaking, chewing, or opening POMALYST
capsules; instructions on dose and administration;
reading the POMALYST 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 POMALYST therapy; not
sharing POMALYST; not donating blood; not
breaking, chewing, or opening POMALYST
capsules; instructions on dose and administration;
reading the POMALYST 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 POMALYST to the POMALYST
REMS, the prescriber, or the pharmacy that
dispensed the POMALYST.
Adhere to the safe-use conditions: Not sharing
POMALYST; not breaking, chewing, or opening
POMALYST capsules; and keeping POMALYST out
of reach of children.
Female children who cannot get pregnant who are prescribed POMALYST:
Before treatment initiation
Receive counseling from the prescriber on the
benefits and risks of POMALYST and the need to
complete the patient survey.
Receive counseling from the pharmacy on the
benefits and risks of POMALYST; not sharing
POMALYST; not donating blood; not breaking,
chewing, or opening POMALYST capsules;
instructions on dose and administration; reading
the POMALYST REMS education materials; and
being compliant with the REMS requirements.
Receive counseling from the pharmacy on
informing the POMALYST prescriber when menses
begins.
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 POMALYST; not sharing
POMALYST; not donating blood; not breaking,
chewing, or opening POMALYST capsules;
instructions on dose and administration; reading
the POMALYST REMS education materials; and
being compliant with the REMS requirements.
Receive counseling from the pharmacy to inform
the POMALYST prescriber when menses begins.
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 menses begins.
Return unused POMALYST to the POMALYST
REMS, the prescriber, or the pharmacy that
dispensed the POMALYST.
Adhere to the safe-use conditions: Not sharing
POMALYST; not breaking, chewing, or opening
POMALYST capsules; and keeping POMALYST out
of reach of children.
Males (adults and children) who are prescribed POMALYST:
Before treatment initiation
Receive counseling from the prescriber on the
benefits and risks of POMALYST, the need to
complete the patient survey, barrier
contraception requirements, and emergency
contraception.
Receive counseling from the pharmacy on the
benefits and risks of POMALYST; not sharing
POMALYST; not donating blood; not breaking,
chewing, or opening POMALYST capsules;
instructions on dose and administration; reading
the POMALYST REMS education materials; and
being compliant with the REMS requirements.
Receive counseling from the pharmacy on
embryo-fetal toxicity with exposure to
POMALYST; 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 POMALYST; not sharing
POMALYST; not donating blood; not breaking,
chewing, or opening POMALYST capsules;
instructions on dose and administration; reading
the POMALYST REMS education materials; and
being compliant with the REMS requirements.
Receive counseling from the pharmacy on
embryo-fetal toxicity with exposure to
POMALYST; 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: 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 POMALYST to the POMALYST
REMS, the prescriber, or the pharmacy that
dispensed the POMALYST.
Adhere to safe-use conditions: Not sharing
POMALYST; not breaking, chewing, or opening
POMALYST capsules; and keeping POMALYST out
of reach of children.
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 POMALYST and safe-use
conditions 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 POMALYST 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 POMALYST and additional safe-use
conditions using the Education and Counseling
Checklist for Pharmacies.
| Education and Counseling Checklist for Pharmacies |
Verify that a prescription authorization number
and patient risk category is documented on each
prescription through the processes and
procedures established as a requirement of the
REMS Program.
Obtain 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 date it
was obtained on the prescription.
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 have it
picked up within 24 hours of obtaining the
confirmation number.
For females (adult and children) who can get
pregnant ship POMALYST the same day the
confirmation number is obtained, or have it
picked up within 24 hours of obtaining the
confirmation number.
At all times
Report pregnancies immediately to the REMS
Program.
Do not distribute, transfer, loan, or sell
POMALYST, except as authorized by the REMS
Program.
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 POMALYST
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 POMALYST REMS.
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 Pomalyst REMS, see the DailyMed link(s).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
03/24/2023
Modified to:
Transfer the application ownership from Celgene to Bristol-Myers Squibb Company (BMS).
Remove the Celgene logo and references to Celgene.
Make administrative updates such as changes to contact department names.
Make editorial changes to the REMS website.
Change the address of the REMS web portal.
08/05/2021
Modified to remove the mobile app for physicians, inclusion of the Patient
REMS Application, clarifying language regarding the question for prescribers about
days of therapy being prescribed, new language for reporting pregnancies, modification
to the disclosure language on the Patient-Physician Agreement Forms (PPAFs), and a
new election checkbox on the PPAFs for patients to request Pomalyst REMS education
materials.
05/14/2020
Modified to remove indication statements from REMS materials; modified the REMS
document to the new format to align with the recommendations in the October 2017
Draft Guidance: Format and Content of a REMS Document for Industry; and remove
prescription forms from the REMS.
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 by patients enrolled in the
REMS.
Update the name of the Veterans Health Administration in the REMS document and
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.
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 inserting 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).
09/14/2015
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.
04/23/2015
Modified to revise the indication statement and information about arterial thromboembolism in the appended REMS materials.
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:
Add and implement a pharmacy portal to facilitate pharmacy activity within the REMS.
Harmonize the REMS with the Thalomid (thalidomide) capsules and Revlimid (lenalidomide) capsules REMS.
Include the implementation of a survey of contraceptive use in females of reproductive potential and a survey of knowledge for pharmacists in the REMS assessment plan.
02/08/2013
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.
