A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the US Food and Drug Administration (FDA) can require for certain medicines to ensure they are used safely. Drug companies and healthcare providers must take extra steps to make sure the benefits of using the drug are greater than the risks. The FDA must approve these steps as part of the REMS.
Treatment with ZENBEXUS™ (iberdomide) may result in birth defects or death of an unborn baby if taken during pregnancy, including the time before you know you are pregnant.
Before you can receive treatment with ZENBEXUS, you first must be enrolled in ZENBEXUS REMS by your certified HCP prescriber.
How to enroll and take part in ZENBEXUS REMS
All patients must:
- Review the Patient Guide
- Enroll in the REMS Program by completing a Patient Enrollment Form with the prescriber
- Adhere to safe-use conditions
- Agree not to share their ZENBEXUS
For females who can become pregnant
Before treatment, I must:
- Use 2 effective methods of birth control at the same time for 4 weeks before I start taking ZENBEXUS
- Take 2 pregnancy tests completed in a medical setting (e.g., prescriber’s office, clinic, or laboratory) before I start taking ZENBEXUS
- There is a 7-day prescription window where the pregnancy test remains valid. If the 7-day pregnancy test window is missed, I will need to repeat the pregnancy test
- Be counseled about:
- The risk of serious birth defects or death of an unborn baby
- Using effective methods of birth control for at least 4 weeks before, during, and 4 weeks after stopping ZENBEXUS
- Having pregnancy tests every 4 weeks
- Completing a patient survey before every prescription
- Not sharing ZENBEXUS
- Not donating your eggs or blood during treatment and for 4 weeks after your treatment last dose
- Receive counseling from the pharmacy every 4 weeks
- Contact my prescriber right away if I think that I may be pregnant and stop taking my medication
During treatment, I must:
- Receive counseling from my prescriber and pharmacy about the risk of serious birth defects, the need to use effective methods of birth control, and to stop taking my medication and immediately contact my prescriber if I suspect that I might be pregnant every 4 weeks
- Get a pregnancy test as directed by the prescriber every 4 weeks
- If the 7-day pregnancy test window is missed, I will need to repeat the pregnancy test
- Use pregnancy prevention methods as described in the Patient Guide , not to take ZENBEXUS if I am pregnant, breastfeeding, or not using pregnancy prevention methods, and not to become pregnant
- Complete a Patient Survey every 4 weeks
After treatment discontinuation, for 1 month, I must:
- Get a pregnancy test as directed by the prescriber
- Use pregnancy prevention methods as described in the Patient Guide , not to take ZENBEXUS if I am pregnant, breastfeeding, or not using pregnancy prevention methods, and not to become pregnant
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 I might be pregnant
- Report results of all pregnancy tests to my prescriber as directed
- Return any unused ZENBEXUS to a drug take back location
For males
Before treatment, I must:
- Be counseled about:
- The risk of serious birth defects or death of an unborn baby
- Using a latex or synthetic condom during any sexual contact during your treatment even if you have had a successful vasectomy
- Completing a patient survey before every prescription
- Not donating blood or sperm during treatment and for 4 weeks after your treatment last dose
- Not sharing your ZENBEXUS
During treatment, I must:
- Complete a Patient Survey every 4 weeks
- Receive counseling from my prescriber and pharmacy about the risk of serious birth defects, the need to use effective methods of birth control, and to stop taking my medication and immediately contact my prescriber if I suspect that I might be pregnant every 4 weeks
After treatment discontinuation, for 4 weeks, I must:
- Use a latex or synthetic condom during any sexual contact
- Not donate sperm
- Not donate blood
At all times, I must:
- Inform your prescriber about unprotected sexual contact with a female who can become pregnant, or about a sexual partner who might be pregnant
- Not share ZENBEXUS
- Return any unused ZENBEXUS to a drug take back location
For females who cannot become pregnant
Before treatment, I must:
- Be counseled about:
- The risk of serious birth defects or death of an unborn baby if there is a change in your reproductive status
- Not donating blood during treatment and for 4 weeks after your treatment last dose
During treatment, every 6 months, I must:
- Be counseled about:
- The risk of of serious birth defects or death of an unborn baby if there is a change in my reproductive status
- Not sharing ZENBEXUS
- Not donating blood during treatment and for 4 weeks after your treatment last dose
- Returning unused ZENBEXUS to a drug take back program
At all times, I must:
- Inform my prescriber if there is a change in my reproductive status
- Not share ZENBEXUS
- Return any unused ZENBEXUS to a drug take back location
