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 to and administered in medically supervised healthcare setting that provides patient monitoring.
- Ensuring that pharmacies and healthcare settings that dispense SPRAVATO® are certified.
- Ensuring that each patient is informed about serious adverse outcomes from dissociation and sedation and need for monitoring.
- Enrollment of all patients in the REMS (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.
Details and resources can be found at: www.SPRAVATOrems.com