For Prescribers

Before treatment

• Assess the patient’s reproductive status using the definitions in the Prescriber and Pharmacy Guide 

For females who can become pregnant:

• Counsel patients every 4 weeks using the Patient Guide  on:
  • The risk of embryo-fetal toxicity
  • The need to use effective methods of contraception for 4 weeks prior to treatment initiation, during treatment, and for 4 weeks following discontinuation of treatment
  • The need to complete pregnancy tests every 4 weeks
  • Not donating eggs during treatment and for 4 weeks after treatment last dose
  • Not donating blood during treatment and for 4 weeks after treatment last dose
  • The need to immediately contact their prescriber 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
• Assess the patient’s pregnancy status by reviewing 2 pregnancy test results completed in a medical setting (e.g., prescriber’s office, clinic, or laboratory)
  • 10 to 14 days before treatment initiation, conduct the first pregnancy test and then conduct a second pregnancy test within 24 hours before treatment initiation
  • Document using the Patient Enrollment Form 
• Enroll the patient by completing a Patient Enrollment Form  and submitting to ZENBEXUS REMS
• Provide a copy of the Patient Guide  to the patient

For males:

• Enroll patients in ZENBEXUS REMS by completing the Patient Enrollment Form 
• Counsel patients every 4 weeks using the Patient Guide  on:
  • The risk of embryo-fetal toxicity and to remind the patient to use a latex or synthetic condom
  • Not donating sperm during treatment and for 4 weeks after treatment last dose
  • Not donating blood during treatment and for 4 weeks after treatment last dose
  • The need to immediately contact their prescriber if pregnancy is suspected in their sexual partner
  • Provide a copy of the Patient Guide  to the patient
• Counsel patients on the need to complete the Patient Survey every 4 weeks during treatment

For females who cannot become pregnant:

• Enroll patients in ZENBEXUS REMS by completing the Patient Enrollment Form 
• Counsel patients every 6 months using the Patient Guide  on:
  • The risk of embryo-fetal toxicity and to report a change in reproductive status
  • Not sharing ZENBEXUS
  • Not donating blood during treatment and for 4 weeks after treatment last dose

During treatment, every 4 weeks

For females who can become pregnant:

• Assess the female’s pregnancy status by reviewing a pregnancy test and confirming a negative result
• Counsel patients on:
  • The risk of embryo-fetal toxicity
  • Pregnancy prevention requirements
  • The need to perform required pregnancy testing every 4 weeks
  • The need to immediately contact their prescriber if they miss a menstrual period or if pregnancy is suspected
• Complete a mandatory, confidential Prescriber Survey to verify patient’s reproductive status, pregnancy prevention methods, negative pregnancy test result, and completion of counseling. Complete survey online or by telephone and obtain authorization for each prescription
• Prescribe no more than a 28-day supply, with no refills
• Send the prescription to a certified pharmacy

For males:

• Counsel patients on:
  • The risk of embryo-fetal toxicity and to remind the patient to use a latex or synthetic condom
  • Not donating sperm during treatment and for 4 weeks after treatment last dose
  • The need to complete a Patient Survey every 4 weeks
  • The need to immediately contact their prescriber if pregnancy is suspected in their sexual partner
• Obtain authorization by contacting the REMS to complete the Prescriber Survey
• Send the prescription to a certified pharmacy

After treatment has been discontinued

For females who can become pregnant:

• For 4 weeks, assess the patient’s pregnancy status by reviewing a pregnancy test and confirming a negative result
• Counsel the patient to continue using effective contraception methods for at least 4 weeks

For males:

• Counsel patients on:
  • The risk of embryo-fetal toxicity
  • The need to use a latex or synthetic condom
  • The importance of not donating blood or sperm

At all times

• Report any pregnancies immediately to ZENBEXUS REMS at 1-888-423-5436

At all times, within 10 business days

• Report a change or misclassification in reproductive status to ZENBEXUS REMS using the Change in Reproductive Potential Status Form  or by calling ZENBEXUS REMS at 1-888-423-5436