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Approved Risk Evaluation and Mitigation Strategies (REMS)

Spravato (esketamine)
NDA #211243
REMS last update: 01/03/2022



What is the purpose of the REMS?

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 and administered to patients in a medically supervised healthcare setting that monitors these patients
  • Ensuring pharmacies and healthcare settings that dispense SPRAVATO are certified
  • Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
  • Enrolling all patients who receive treatment in an outpatient healthcare setting in a registry to further characterize the risks and support safe use

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
01/03/2022 Modified to reflect changes to the Spravato REMS Patient Monitoring Form, including revisions to the format of some of the data-capturing fields and the addition of a field to capture the lot number field of Spravato.
07/31/2020 Modified to change the requirements for the certified healthcare setting based on inpatient or outpatient setting in the REMS document; aligning the patient enrollment form, REMS website, and REMS Program Overview with these requirements; and replacing the single healthcare setting enrollment form with setting specific enrollment forms.
06/25/2019 Modified to amend some of the data-capturing fields in the Healthcare Setting Enrollment Form, Pharmacy Enrollment Form, and Patient Monitoring Form.
03/05/2019 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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