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Frequently Asked Questions (FAQs)

Frequently Asked Questions

What are the serious risks of ZENBEXUS™ (iberdomide)?

ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. Advise all patients of the risk of embryo-fetal toxicity. Advise females who can become pregnant to use effective contraception. Advise males that ZENBEXUS may pass into human semen, to use a latex or synthetic condom, and for males to not donate sperm. Using the Patient Guide , counsel:

All Patients on:

  • Following safe-use conditions
  • Not sharing ZENBEXUS
  • Not donating blood during treatment and for 4 weeks after discontinuation
  • Returning any unused ZENBEXUS to a drug take back location

Females who can become pregnant on:

  • The risk of embryo-fetal toxicity
  • Using effective methods of contraception for 4 weeks prior to treatment initiation, during treatment, and for 4 weeks following discontinuation of treatment
  • Completing pregnancy tests every 2 or 4 weeks
  • Completing a Patient Survey every 4 weeks
  • Contacting you if the patient misses a menstrual period or if pregnancy is suspected
  • Not donating eggs during treatment and 4 weeks after treatment

Males on:

  • The risk of embryo-fetal toxicity
  • Using a latex or synthetic condom
  • Not donating sperm during treatment and 4 weeks after treatment
  • Completing a Patient Survey every 4 weeks

Females who cannot become pregnant on:

  • The risk of embryo-fetal toxicity after a change in reproductive status
  • Contacting the prescriber right away if there is a change to their reproductive status

What REMS requirements must I follow as a prescriber?

Prescribers must complete the following steps to prescribe ZENBEXUS:

  1. Review the drug's Prescribing Information and the Prescriber and Pharmacy Guide .
  2. Complete the Prescriber Enrollment Form  and submit it to the REMS.
    1. Prescribers will attest to their understanding of the risks of ZENBEXUS and agree to comply with all requirements of ZENBEXUS REMS.
    2. Complete the form online at www.bmsremspatientsafety.com, via email to REMSContactCenter@bms.com, or by faxing the completed form to 1-877-296-1932.
  3. Before treatment initiation (first prescription), within 10–14 days and again within 24 hours:
    • 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 .
  4. Counsel females who can become pregnant 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 .
  5. Counsel male patients 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 .
  6. Counsel females who cannot become pregnant on the risk of embryo-fetal toxicity after a change in reproductive status and to contact their prescriber right away if there is a change to their reproductive status. Provide a copy of the Patient Guide .
  7. Enroll patients in the REMS by completing and submitting the Patient Enrollment Form  with the patient.
  8. Complete a Prescriber Survey before each prescription for:
    • Females who can become pregnant: to verify the patient's reproductive status, pregnancy prevention methods, negative pregnancy test result, and completion of counseling.
    • Male patients: to verify the use of latex or synthetic condom, that the patient has not donated sperm, and completion of counseling.
  9. For females who can become pregnant and males: Prescribe no more than a 28 days' supply. Do not prescribe refills.
  10. Send prescriptions to only REMS-certified pharmacies.
  11. For patients with a lapse of treatment of 12 consecutive months or longer who will restart treatment with ZENBEXUS: re-enroll the patient.

How often should I complete the Prescriber Survey?

For females who can become pregnant AND for male patients (Prescriber Survey is required for both), complete before each prescription:

  1. For females who can become pregnant: Assess the patient's pregnancy status by reviewing the results of the pregnancy test and confirming a negative result.
  2. Complete and submit a Prescriber Survey for each female who can become pregnant and for each male patient.
  3. Counsel the females who can become pregnant on the risk of embryo-fetal toxicity, pregnancy prevention requirements, and survey requirements using the Patient Guide . For males: counsel on the risk of embryo-fetal toxicity, using latex or synthetic condom, not donating sperm, and survey requirements using the Patient Guide .
  4. Obtain authorization online at www.bmsremspatientsafety.com or by contacting ZENBEXUS REMS at 1-888-423-5436 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: verify the use of latex or synthetic condom, that the patient has not donated sperm, and completion of counseling.
  5. For females who can become pregnant and males: Prescribe no more than a 28 days' supply. Do not prescribe refills.

How shall I report a change in my patients' reproductive potential status?

At all times, within 10 business days, I must:

What are the pregnancy testing requirements during treatment?

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.
  • For females who can become pregnant with irregular menstrual cycles: Every 2 weeks after the first 4 weeks, within 7 days before each prescription.
  • For females who can become pregnant with regular menstrual cycles: Every 4 weeks after the first 4 weeks, within 7 days before each prescription. Document and submit the result to the REMS.
  • 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.

After treatment discontinuation, 4 weeks after the date of the last dose:

  • For females who can become pregnant: Assess the patient's pregnancy status by reviewing a pregnancy test and confirming a negative result.

What should I do if a pregnancy occurs?

Report any pregnancies in female patients or female partners of male patients immediately to the REMS.

What are the REMS requirements for females who cannot become pregnant?

During treatment, every 6 months: Counsel the patient on the safe use conditions. During treatment, annually: Verify the patient's reproductive status.

What are the serious risks of ZENBEXUS?

ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. Advise females who can become pregnant and males on the risk of embryo-fetal toxicity and all safe-use measures listed on the Pharmacy Counseling Checklist .

What REMS requirements must my pharmacy follow?

Pharmacies must be contracted before being certified. For more information, please contact the REMS Call Center at 1-888-423-5436.

To become a REMS-certified pharmacy to dispense ZENBEXUS:

  1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS requirements on behalf of the pharmacy.
  2. Have the Authorized Representative review the Prescribing Information and the Prescriber and Pharmacy Guide .
  3. Train all relevant staff involved in REMS counseling and dispensing using the Prescriber and Pharmacy Guide .
  4. Have the Authorized Representative enroll in REMS by completing the Pharmacy Enrollment Form  and submitting it to ZENBEXUS REMS.
  5. For females who can become pregnant and males: Establish processes and procedures to complete the Pharmacy Counseling Checklist  and submit it to the REMS.
  6. 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.
  7. For males: Establish processes and procedures to dispense no more than a 28 days' supply.

For females who can become pregnant:

  1. Establish pharmacy processes and procedures to verify there are 7 days or less remaining on the patient's existing prescription, and to dispense no more than a 28 days' supply
  2. Counsel the patient on the risks of embryo-fetal toxicity and safe-use conditions using the Pharmacy Counseling Checklist 
  3. Complete the Pharmacy Counseling Checklist  and submit to ZENBEXUS REMS
  4. Obtain confirmation to dispense by contacting the REMS to verify prescriber is certified; the patient is enrolled, not pregnant, and authorized to receive ZENBEXUS. Document the confirmation number.
  5. 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 (e.g., overnight, ground) avoids delays or interruption in therapy
  6. Dispense ZENBEXUS within 7 days of the date of the last pregnancy test.
  7. Dispense no more than a 28 days' supply. Do not dispense refills.

For male patients:

  • Counsel the patient on the risks of embryo-fetal toxicity and safe-use conditions using the Pharmacy Counseling Checklist .
  • Complete the Pharmacy Counseling Checklist  and submit it to the REMS.
  • Obtain a confirmation to dispense through ZENBEXUS REMS
  • 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 (e.g., overnight, ground) avoids delays or interruption in therapy
  • Dispense no more than a 28 days' supply. Do not dispense refills.

For females who cannot become pregnant:

  • Obtain a confirmation to dispense through ZENBEXUS REMS.
  • 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.

At all times, pharmacies must:

  • 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.
  • Comply with audits carried out by Bristol Myers Squibb Company or a third party acting on behalf of Bristol-Myers Squibb Company.

What are my patients' birth control (contraception) options?

Refer to the ZENBEXUS REMS Prescriber and Pharmacy Guide  for contraception options.

How often should I complete the Pharmacy Counseling Checklist?

For females who can become pregnant AND male patients (Pharmacy Counseling Checklist  is required for both): The ZENBEXUS REMS Pharmacy Counseling Checklist  is to be completed prior to each dispensing. Dispense no more than a 28 days' supply; do not dispense refills.

What are the serious risks of ZENBEXUS?

ZENBEXUS can cause serious fetal harm. Referring to the Patient Guide , your prescriber will counsel females who can become pregnant about:

  • The risk of embryo-fetal toxicity
  • The need to use effective methods of contraception for at least 4 weeks before treatment, during treatment, and for at least 4 weeks after discontinuation of treatment with ZENBEXUS
  • The need to follow the pregnancy testing requirements
  • The need to immediately contact the prescriber if the patient misses a menstrual period or if pregnancy is suspected

What REMS requirements must I follow if I am a female who can become pregnant?

Before treatment, I must:

  1. Review the Patient Guide 
  2. Receive counseling from my prescriber about:
    • The risk of serious birth defects
    • The need to use effective methods of contraception for at least 4 weeks before treatment, during treatment, and for at least 4 weeks following discontinuation of treatment
    • The need to get pregnancy tests as directed by my prescriber (weekly for at least the first 4 weeks of treatment, then based on my menstrual cycle regularity)
    • The need to immediately contact my prescriber if I suspect that I may be pregnant
  3. Get pregnancy tests in a medical setting as directed by my prescriber — within 10–14 days before treatment and again within 24 hours before starting treatment.
  4. Enroll in ZENBEXUS REMS by completing and submitting the Patient Enrollment Form  with my prescriber
  5. Receive counseling from the pharmacy 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.

During treatment, before each prescription, I must:

  • Complete the Patient Survey for Females Who Can Become Pregnant
  • Take a pregnancy test as directed by my prescriber before each prescription
  • Receive counseling from my prescriber about the risk of embryo-fetal toxicity, the need to use effective methods of contraception
  • Receive counseling from my pharmacy on the risk of embryo-fetal toxicity and pregnancy prevention requirements.
  • Get my ZENBEXUS from the pharmacy within 7 days of my last pregnancy test.
  • If I miss the 7-day prescription window: Get a repeat pregnancy test as directed by my prescriber.

After treatment discontinuation, for 4 weeks, I must:

At all times, I must:

  • Inform my prescriber if there is a change in my reproductive status
  • Stop taking ZENBEXUS and contact my prescriber immediately if I suspect that I may be pregnant
  • Report the results of all pregnancy tests to my prescriber as directed.
  • Not share ZENBEXUS.

What REMS requirements must I follow if I am a male patient?

Before treatment, I must:

  1. Review the Patient Guide .
  2. Receive counseling from my prescriber 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.
  3. Enroll in the ZENBEXUS REMS by completing a Patient Enrollment Form  with my prescriber.
  4. Receive counseling from the pharmacy 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.

During treatment, before each prescription, I must:

  • Complete the Patient Survey for Males.
  • Receive counseling from my prescriber and pharmacy on the risk of embryo-fetal toxicity, the latex or synthetic condom requirement, not donating sperm.

During treatment and for 4 weeks after treatment discontinuation, I must:

  • Use latex or synthetic condom and not donate sperm as described in the Patient Guide .

At all times, I must:

  • Inform my prescriber about unprotected sexual contact with a female who can become pregnant, or about a sexual partner who might be pregnant.
  • Not share ZENBEXUS.

What REMS requirements must I follow if I am a female who cannot become pregnant?

Before treatment:

  • Enroll in ZENBEXUS™ REMS by completing the Patient Enrollment Form 
  • Receive counseling from my prescriber on the risk of embryo-fetal toxicity and what to do if there is a change in my reproductive status.

During treatment, every 6 months:

  • Receive counseling from my prescriber on the safe use conditions.

At all times:

  • Inform my prescriber if there is a change in my reproductive status
  • Not share ZENBEXUS.

What are my birth control (contraception) options?

Refer to the ZENBEXUS REMS Patient Guide  for birth control options.

How will I receive my medication?

For females who can become pregnant:

  • Pharmacy processes and procedures must verify there are 7 days or less remaining on the patient's existing prescription and dispense no more than a 28 days' supply
  • Patients must be counseled on the risks of embryo-fetal toxicity and safe-use conditions using the Pharmacy Counseling Checklist 
  • The product will be shipped the same day the confirmation number is obtained or it should be picked up within 24 hours of obtaining the confirmation number. Ensure shipment method (e.g., overnight, ground) avoids delays or interruption in therapy

For male patients:

  • Pharmacy will dispense no more than a 28 days' supply with no refills.
  • The product will be shipped within 24 hours of receiving the confirmation number or 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:

  • The product will be shipped within 24 hours of receiving the confirmation number or picked up within 24 hours of obtaining the confirmation number.

How can I whitelist email addresses and websites related to REMS communications for prescribers?

To ensure that you can access the online web portal available for the REMS program, make certain that the following website URLs are not blocked by your system's firewall, and that these email addresses and websites below are listed as safe senders:

  • https://www.zenbexusrems.com
  • https://www.BMSREMSPatientSafety.com

Why isn't my patient showing up on the Calendar/List view?

In the prescribers portal, there are various reasons a patient's name may not appear within the Calendar/List view, including:

  • The patient may have been hidden
  • The patient may have been deactivated
  • The patient may not have REMS tasks that need to be completed

When a patient is being co-managed by multiple prescribers and/or a different prescriber takes over a patient's care, will I still have access to that patient in the prescribers portal?

Yes, you will continue to have access to the patient in the "My Patients" tab.

Where can I see my patient's full history and status in the prescribers portal?

Go to the "Manage My Patients" tab and click on the patient's name. The patient's account details screen will display related information.

What is the prescription window and how does it affect the portal workflow?

For females who can become pregnant: The authorization to dispense is valid for 7 days from the date of the last pregnancy test. If a patient does not receive ZENBEXUS within this 7-day window, a repeat confirmatory pregnancy test is required before a new authorization can be issued.

For males: The authorization is valid for 30 days.

For females who cannot become pregnant: The authorization is valid unless the risk category changes.

What is the prescription window and how does it affect the portal workflow?

For females who can become pregnant: The authorization to dispense is valid for 7 days from the date of the last pregnancy test. If a patient does not receive ZENBEXUS within this 7-day window, a repeat confirmatory pregnancy test is required before a new authorization can be issued.

For males: The authorization is valid for 30 days.

For females who cannot become pregnant: The authorization is valid unless the risk category changes.

How can I whitelist email addresses and websites related to REMS communications for pharmacies?

To ensure that you can access the online web portal available for the REMS program, make certain that the following website URLs are not blocked by your system's firewall, and that these email addresses and websites below are listed as safe senders:

  • https://www.zenbexusrems.com
  • https://www.BMSREMSPatientSafety.com
References

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