For Pharmacies

Prior to certification

1. Designate an Authorized Representative to complete the certification process and oversee implementation and compliance with ZENBEXUS REMS on behalf of the pharmacy.
2. Review the ZENBEXUS™ (iberdomide) Prescribing Information. 
3. Review the Prescriber and Pharmacy Guide. 
4. Complete and submit the Pharmacy Enrollment Form  to ZENBEXUS REMS.
5. Train all relevant staff involved in counseling and dispensing ZENBEXUS using the Prescriber and Pharmacy Guide. 
6. Maintain records of dispensing information including the confirmation numbers and the date it was obtained, REMS training of relevant staff, and that all processes and procedures are being followed.
7. Comply with audits conducted by BMS or by a third party acting on behalf of BMS.
8. Have a new Authorized Representative enroll by completing and submitting a Pharmacy Enrollment Form  if the Authorized Representative changes.

Before dispensing ZENBEXUS

For all patients:

• Verify that the patient is enrolled and the prescriber is certified in ZENBEXUS REMS
• 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
• Advise the need to adhere to safe-use conditions
• Advise not sharing ZENBEXUS

For females who can become pregnant:

• Counsel patients using the Pharmacy Counseling Checklist  on:
  • The risk of embryo-fetal toxicity
  • The need to use effective methods of contraception every time they have sex, beginning at least 4 weeks before taking ZENBEXUS, while taking ZENBEXUS, and for at least 4 weeks after stopping ZENBEXUS
  • The need to complete monthly pregnancy tests
  • The need to immediately contact their prescriber and stop treatment if the patient misses a menstrual period or if pregnancy is suspected
• Counsel patients on the need to complete the Patient Survey every 4 weeks during treatment
• Report any suspected pregnancy to ZENBEXUS REMS at 1-888-423-5436
• Establish processes and procedures to verify there are 7 days or less remaining on the patient’s existing prescription
• Submit a completed Pharmacy Counseling Checklist  to ZENBEXUS REMS

For males:

• Counsel patients using the Pharmacy Counseling Checklist  on:
  • The risk of embryo-fetal toxicity
  • The need to use a latex or synthetic condom every time they have sex beginning at least 4 weeks before taking ZENBEXUS, while taking ZENBEXUS, and for at least 4 weeks after stopping ZENBEXUS
  • The importance of not donating blood or sperm during treatment and for 4 weeks after treatment last dose
• Counsel patients on the need to complete the Patient Survey every 4 weeks during treatment
• Submit a completed Pharmacy Counseling Checklist  to ZENBEXUS REMS

During treatment

For females who can become pregnant:

• Obtain confirmation to dispense through ZENBEXUS REMS
• Dispense no more than a 28-day supply with no refills
• Ship medication the same day the confirmation number is obtained or have it picked up within 24 hours of obtaining the confirmation number
• Ensure shipment method avoids delays or interruption in therapy
• Report any suspected pregnancy to ZENBEXUS REMS at 1-888-423-5436

For males:

• Dispense no more than a 28-day supply with no refills
• Report any suspected pregnancy to ZENBEXUS REMS at 1-888-423-5436

For females who cannot become pregnant and males:

• Obtain confirmation to dispense through ZENBEXUS REMS
• Ship dispensed medication within 24 hours of receiving confirmation number or have it picked up within 24 hours of obtaining the confirmation number
• Ensure shipment method avoids delays or interruption in therapy

Additional requirements:

• Do not distribute, transfer, loan, or sell ZENBEXUS, except as authorized by ZENBEXUS REMS
• Notify Bristol Myers Squibb (BMS) immediately of any dispense changes or cancellations after a dispense has been confirmed with ZENBEXUS REMS
• Maintain records of dispensing information including the confirmation number and the date it was obtained
• Maintain records of completion of ZENBEXUS REMS training by relevant staff, and that all processes and procedures are being followed
• Comply with audits conducted by BMS or a third party acting on behalf of BMS to ensure that all processes and procedures are in place and being followed
• Have a new Authorized Representative enroll by completing and submitting a Pharmacy Enrollment Form  if the Authorized Representative changes