A REMS is a strategy to manage known or potential risks associated with a drug and is required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.
SPRAVATO® (esketamine) nasal spray CIII is available only through a restricted distribution program called the SPRAVATO® REMS because of the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO. SPRAVATO® is intended for use only in a certified Healthcare Setting.
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.
Inpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®Inpatient Healthcare Setting Certification
Outpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®Outpatient 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® treatment in an Outpatient Healthcare SettingPatient
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