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Welcome to ZENBEXUS REMS (Risk Evaluation and Mitigation Strategy)

Welcome to ZENBEXUS REMS (Risk Evaluation and Mitigation Strategy)

What is ZENBEXUS REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is designed to manage known or potentially serious risks associated with a drug. It is required by the US Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.

Treatment with ZENBEXUS™ (iberdomide) may result in embryo-fetal toxicity. Therefore, the FDA requires that all prescribers and pharmacies certify with ZENBEXUS REMS. All patients must enroll in and comply with all the safe-use requirements of ZENBEXUS REMS.

Prescribers can log into the REMS Portal  to complete certification in the program.

Once certified, use the portal to manage REMS tasks and patients.

The Pharmacy Authorized Representative can log into the REMS Portal  to complete certification.

Once certified, use the portal to invite pharmacy staff members to manage REMS tasks and patients.

Prescribers

Prescribers must be certified in ZENBEXUS REMS in order to prescribe ZENBEXUS.

Learn about prescriber certification.

Pharmacies

Pharmacies must be certified in ZENBEXUS REMS in order to dispense ZENBEXUS.

Learn about pharmacy certification.

Patients

Patients must be enrolled in ZENBEXUS REMS in order to receive ZENBEXUS.

Learn about patient enrollment.

Contact Information

Suspected pregnancies phone icon 1-888-423-5436 (REMS Call Center)
Suspected adverse events (side effects) or product quality complaints associated with ZENBEXUS

phone icon 1-888-423-5436 (REMS Call Center)

phone icon 1-800-FDA-1088

computer icon www.fda.gov/medwatch



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