SPRAVATO™ REMS

What is the SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy)?

A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product.

The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO™ administration, and abuse and misuse of SPRAVATO™ by:

• Ensuring that SPRAVATO™ is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
• Ensuring pharmacies and healthcare settings that dispense SPRAVATO™ are certified
• Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
• Enrollment of all patients in a registry to further characterize the risks and support safe use

SPRAVATO™ is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO™ must never be dispensed directly to a patient for home use.

SPRAVATO™ is only available through select distribution channels.

If you have any questions about the SPRAVATO™ REMS or need help with certification or enrollment, call 1-855-382-6022 Monday – Friday 8AM – 8PM ET