SPRAVATO® REMS

(Risk Evaluation and Mitigation Strategy)

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

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.

Program Requirements

Inpatient Healthcare Setting

Inpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®

Inpatient Healthcare Setting Certification

Outpatient Healthcare Setting

Outpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®

Outpatient Healthcare Setting Certification

Pharmacy

Pharmacies must be certified in the SPRAVATO® REMS in order to dispense SPRAVATO®

Pharmacy Certification

Patient

Patients must be enrolled in the SPRAVATO® REMS in order to receive SPRAVATO® treatment in an Outpatient Healthcare Setting

Patient
Enrollment

SPRAVATO® Indication

SPRAVATO® is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with oral antidepressant, for the treatment of:
  • Treatment-resistant depression (TRD) in adults.
  • Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

SPRAVATO® is only available through select restricted 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