Key takeaway
Why SPRAVATO® can only be given in certified settings, and what the REMS requires of clinics and patients.
What a REMS is A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program the FDA can require for medicines with serious risks. SPRAVATO® has one because of the risks of sedation, dissociation, respiratory depression, and abuse and misuse.
What it requires - Certified settings only. SPRAVATO® may be dispensed and administered only in healthcare settings certified in the REMS. - Supervised use. Patients self-administer the spray under direct observation of a healthcare provider. - Monitoring. Patients are monitored for at least two hours after each dose. - No home use. The medicine is never given to patients to take home. - Enrollment. Patients are enrolled in the program, and adverse events are reported.
What this means when you search When comparing treatment centers, ask whether the location is a certified SPRAVATO® treatment setting. Our directory shows clinic details the clinic itself has published; confirm certification directly with the clinic.
Source: FDA prescribing information and official SPRAVATO® REMS materials. This site is independent and not affiliated with the REMS program.
This page is informational and is not medical advice.