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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.
Review the drug’s Prescribing Information and Prescriber and
Pharmacy Guide.
Enroll in the REMS by completing the Prescriber Enrollment Form
and submitting it to the REMS.
For healthcare providers who allow patients to complete
pregnancy tests outside of a medical setting: Establish processes
and procedures to obtain pregnancy test results from the patient
and to minimize misinterpretation and falsification.
Before treatment initiation
(first prescription), within 10 -
14 days and again within 24
hours
Assess the patient’s reproductive status using Prescriber and
Pharmacy Guide. Document and submit using the Patient
Enrollment Form.
For females who can become pregnant: Assess the patient’s
pregnancy status by reviewing the pregnancy tests completed in
a medical setting (e.g., prescriber’s office, clinic, or laboratory)
and confirming negative results. Document and submit the
results to the REMS using the Patient Enrollment Form.
Before treatment initiation
(first prescription)
For females who can become pregnant: Counsel the patient on
the risk of embryo-fetal toxicity, pregnancy prevention
requirements, and need to complete the Patient Survey for
Females Who Can Become Pregnant before each prescription during treatment. Provide a copy of the Patient Guide to the
patient.
For males: Counsel the patient on the risk of embryo-fetal
toxicity, the latex or synthetic condom requirement, not
donating sperm, and the need to complete the Patient Survey
for Males before each prescription during treatment. Provide a
copy of the Patient Guide to the patient.
For females who cannot become pregnant: Counsel the patient
on the risk of embryo-fetal toxicity and to report a change in
reproductive status.
For all patients: Enroll the patient by completing and submitting
the Patient Enrollment Form.
For females who can become pregnant who do not receive
ZENBEXUS within 7 days of their pregnancy test (prescription
window) and have not started ZENBEXUS: Assess the patient’s
pregnancy status by reviewing a repeat confirmatory pregnancy
test completed in a medical setting (prescriber’s office, clinic,
laboratory) and confirming a negative result. Document and
submit the result to the REMS.
During treatment; weekly for
at least the first 4 weeks
For females who can become pregnant: Assess the patient's
pregnancy status by reviewing a pregnancy test and confirming
a negative result.
During treatment; every 2
weeks after the first 4 weeks,
within 7 days before each
prescription
For females who can become pregnant with irregular menstrual
cycles: Assess the patient's pregnancy status by reviewing a
pregnancy test and confirming a negative result.
During treatment; every 4
weeks after the first 4 weeks,
within 7 days before each
prescription
For females who can become pregnant with regular menstrual
cycles: Assess the patient's pregnancy status reviewing a
pregnancy test and confirming a negative result. Document and
submit the result to the REMS.
During treatment; before
each prescription
For females who can become pregnant: Counsel the patient on
the risk of embryo-fetal toxicity, pregnancy prevention
requirements and survey requirements using the Patient Guide.
For males: Counsel the patient on risk of embryo-fetal toxicity,
using latex or synthetic condom, not donating sperm, and
survey requirements using the Patient Guide.
For females who can become pregnant: Obtain authorization by
contacting the REMS to complete the Prescriber Survey to verify
the patient’s reproductive status, pregnancy prevention
methods, negative pregnancy test result, and completion of
counseling.
For males: Obtain authorization by contacting the REMS to
complete the Prescriber Survey to verify the use of latex or
synthetic condom, the patient has not donated sperm, and
completion of counseling.
For females who can become pregnant who do not receive
ZENBEXUS within 7 days of their pregnancy test: Assess the
patient’s pregnancy status by reviewing a repeat pregnancy test and confirming a negative result. Document and submit the
result to the REMS.
During treatment; every 6
months
For females who cannot become pregnant: Counsel the patient
on the safe use conditions.
During treatment; annually
After treatment discontinuation, 4 weeks after
the date of the last dose
For females who cannot become pregnant: Verify the patient’s
reproductive status.
For females who can become pregnant: Assess the patient's
pregnancy status by reviewing a pregnancy test and confirming
a negative result.
At all times
For females who can become pregnant and males: Prescribe no
more than a 28 days’ supply.
For females who can become pregnant and males: Not prescribe
refills.
Report any pregnancies in female patients or female partners of
male patients immediately to the REMS.
For healthcare providers who allow patients to complete
pregnancy tests outside of a medical setting: Obtain pregnancy
test results from the patient and minimize misinterpretation and
falsification of pregnancy tests through the processes and
procedures established as a requirement of the REMS.
For patients with a lapse of treatment of 12 consecutive months
or longer who will restart treatment with ZENBEXUS: re-enroll
the patient.
At all times, within 10
business days
Report a change or misclassification in reproductive status to the
REMS using the Change in Reproductive Potential Status Form.
Females who can become pregnant who are prescribed ZENBEXUS:
Before treatment initiation; 4
weeks
Adhere to the safe use conditions: use pregnancy prevention
methods and not get pregnant as described in the Patient Guide.
Before treatment initiation;
within 10-14 days and again
within 24 hours
Get pregnancy tests in a medical setting as directed by your
prescriber.
Before treatment initiation
Review the Patient Guide.
Receive counseling from the prescriber on the risks of embryofetal
toxicity, pregnancy prevention requirements and need to
complete the Patient Survey for Females Who Can Become
Pregnant before each prescription during treatment.
Enroll in the REMS by completing the Patient Enrollment Form
with the prescriber. Enrollment information will be provided to the
REMS.
Receive counseling from the pharmacy on the risk of embryofetal
toxicity, pregnancy prevention requirements and need to
complete the Patient Survey for Females Who Can Become
Pregnant before each prescription during treatment.
For patients who miss the 7-day prescription window and have
not started ZENBEXUS: Get a repeat pregnancy test in a medical
setting as directed by your prescriber.
During treatment; before
each prescription
Receive counseling from the prescriber on embryo-fetal toxicity,
the pregnancy prevention requirements and need to complete the
Patient Survey for Females Who Can Become Pregnant before
each prescription.
Get a pregnancy test as directed by the prescriber.
Complete the Patient Survey for Females Who Can Become
Pregnant.
Receive counseling from the pharmacy on the risk of embryofetal
toxicity and pregnancy prevention requirements and need to
complete the Patient Survey for Females Who Can Become
Pregnant before each prescription.
During treatment, within 7
days of the last pregnancy
test
For females picking up ZENBEXUS: Get your ZENBEXUS from the
pharmacy.
During treatment
For patients who miss the 7-day prescription window: Get a
repeat pregnancy test as directed by your prescriber.
During treatment and after
treatment discontinuation; for
4 weeks
Adhere to the safe-use conditions: Use pregnancy prevention
methods as described in the Patient Guide, not take ZENBEXUS if
pregnant, breastfeeding, or not using pregnancy prevention
methods, and not get pregnant.
After treatment
discontinuation, 4 weeks after
the date of the last dose
Get a pregnancy test as directed by the prescriber.
At all times
Inform the prescriber immediately if you think you may be
pregnant. Stop taking ZENBEXUS immediately.
Inform the prescriber if there is a change in reproductive status.
Report the results of all pregnancy tests to your prescriber as
directed.
Adhere to safe use conditions: not share ZENBEXUS.
Males who are prescribed ZENBEXUS:
Before treatment initiation
Review the Patient Guide.
Receive counseling from the prescriber on the risk of embryofetal
toxicity, the latex or synthetic condom requirement, not
donating sperm, and the need to complete the Patient Survey
for Males before each prescription during treatment.
Enroll in the REMS Program by completing a Patient Enrollment
Form with the prescriber. Enrollment information will be provided
to the REMS Program.
Receive counseling from the pharmacy on the risk of embryofetal
toxicity; the latex or synthetic condom requirement, not
donating sperm; and the need to complete the Patient Survey
for Males before each prescription during treatment.
During treatment; before
each prescription
Receive counseling from the prescriber on the risk of embryofetal
toxicity, the latex or synthetic condom requirement, not
donating sperm, and the need to complete the Patient Survey
for Males.
Complete the Patient Survey for Males.
Receive counseling from the pharmacy on the risk of embryofetal
toxicity, the latex or synthetic condom requirement, not
donating sperm, and the need to complete the Patient Survey
for Males.
During treatment and after
treatment discontinuation; for
4 weeks
Adhere to the safe-use conditions: Use latex or synthetic
condom and not donate sperm as described in the Patient Guide.
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.
Adhere to safe-use conditions: Not share ZENBEXUS
Females who cannot become pregnant who are prescribed ZENBEXUS:
Before treatment initiation
Review the Patient Guide.
Receive counseling from the prescriber on the risk of embryofetal
toxicity and if there is a change in reproductive status.
Enroll in the REMS by completing the Patient Enrollment Form
with the prescriber. Enrollment information will be provided to
the REMS.
During treatment; every 6
months
Receive counseling from the prescriber on the safe use
conditions.
At all times
Inform the prescriber if there is a change in reproductive status.
Adhere to the safe-use conditions: Not share ZENBEXUS.
Pharmacies that dispense ZENBEXUS must:
To become certified to
dispense
Designate an Authorized Representative to carry out the
certification process and oversee implementation and
compliance with the REMS requirements on behalf of the
pharmacy.
Have the Authorized Representative review the Prescribing
Information and the Prescriber and Pharmacy Guide.
Train all relevant staff involved in REMS counseling and
dispensing using the Prescriber and Pharmacy Guide.
For females who can become pregnant and males: Establish
processes and procedures to complete the Pharmacy Counseling
Checklist and submit it to the REMS.
For females who can become pregnant: Establish processes and
procedures to dispense when there are 7 days or less remaining
on the patient’s existing prescription and to dispense no more
than a 28 days’ supply.
For males: Establish processes and procedures to dispense no
more than a 28 days’ supply.
Have the Authorized Representative enroll in the REMS by
completing and submitting the Pharmacy Enrollment Form to
the REMS.
Before dispensing
For females who can become pregnant and males: Counsel the
patient on the risks of embryo-fetal toxicity and safe-use
conditions using the Pharmacy Counseling Checklist.
For females who can become pregnant and males: Complete
the Pharmacy Counseling Checklist and submit it to the REMS
through the processes and procedures established as a
requirement of the REMS.
For all patients: Obtain confirmation to dispense each
prescription by contacting the REMS to verify prescriber is
certified; the patient is enrolled, not pregnant, and authorized
to receive ZENBEXUS. Document the confirmation number.
To maintain certification to
dispense
If the Authorized Representative changes, have the new
Authorized Representative enroll in the REMS by completing and
submitting the Pharmacy Enrollment Form.
At all times
For females who can become pregnant: Dispense only if there
are 7 days or less remaining on the existing prescription.
For females who can become pregnant: Dispense ZENBEXUS
within 7 days of the date of the last pregnancy test.
For females who can become pregnant receiving ZENBEXUS:
Ship product the same day the confirmation number is obtained,
or have it picked up within 24 hours of obtaining the
confirmation number. Ensure shipment method (overnight,
ground) avoids delays or interruption in therapy.
For females who cannot become pregnant and males receiving
ZENBEXUS: Ship dispensed product within 24 hours of receiving
the confirmation number or have it picked up within 24 hours of
obtaining the confirmation number. Ensure shipment method
(overnight, ground) avoids delays or interruption in therapy.
For females who can become pregnant and males: Dispense no
more than a 28 days’ supply.
For females who can become pregnant and males: Not dispense
refills.
Report pregnancies to the REMS.
Do not distribute, transfer, loan, or sell ZENBEXUS except as
authorized by the REMS.
Maintain records of dispensing information.
Maintain records of completion of the REMS training by relevant
staff.
Maintain records that all processes and procedures are in place
and are being followed.
Comply with audits carried out by Bristol Myers Squibb Company
or a third party acting on behalf of Bristol-Myers Squibb
Company to ensure that all processes and procedures are in
place and are being followed.
Wholesalers-distributors that distribute ZENBEXUS must:
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 ZENBEXUS on the
REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of completion of the REMS training by relevant
staff.
Maintain records of drug distribution for ZENBEXUS shipments.
Comply with audits conducted by Bristol-Myers Squibb Company
or a third party acting on behalf of Bristol-Myers Squibb
Company 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 Zenbexus 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
08/13/2026
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.
