(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:
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.
Healthcare Settings must be certified in the SPRAVATO™ REMS in order to treat patients with SPRAVATO™Healthcare Setting Certification
Pharmacies must be certified in the SPRAVATO™ REMS in order to dispense SPRAVATO™Pharmacy Certification
Patients must be enrolled in the SPRAVATO™ REMS in order to receive SPRAVATO™ treatmentPatient Enrollment
SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjuction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.
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