Approved Risk Evaluation and Mitigation Strategies (REMS)

Spravato (esketamine)
NDA #211243
REMS last update: 06/25/2019



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
  • Enrollment of all patients 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

Healthcare settings that dispense Spravato must:

To become certified to dispense

  • Have a prescriber onsite during Spravato administration and monitoring.
  • Have healthcare provider(s) onsite to monitor patients.
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the healthcare setting.
  • Have the authorized representative review the Spravato prescribing information.
  • Have the authorized representative enroll in the REMS Program by completing the Healthcare Setting Enrollment Form and submitting it to the REMS Program.
    | Healthcare Setting Enrollment Form |
  • Train all relevant staff involved in prescribing, dispensing, and administering Spravato on 1) Patient self-administration under the supervision of a healthcare provider; and 2) Monitoring for resolution of sedation and dissociation and changes in vital signs for a minimum of 2 hours.
  • Establish processes and procedures to identify new staff involved in prescribing, dispensing, and administering Spravato and ensure they are trained on 1) Patient self-administration under the supervision of a healthcare provider; 2) Monitoring for resolution of sedation and dissociation and changes in vital signs for a minimum of 2 hours.
  • Establish processes and procedures to enroll the patient in the REMS Program.
  • Establish processes and procedures to counsel the patient on the need for enrollment, monitoring, and risks of sedation and dissociation.
  • Establish processes and procedures to verify the patient is enrolled in the REMS Program before each administration and that Spravato is not dispensed for use outside the certified healthcare setting.
  • Establish processes and procedures to complete and submit the Patient Monitoring Form after each administration within 7 calendar days.
    | Patient Monitoring Form |
Before treatment initiation (first dose)

  • Counsel the patient on the risks and need for monitoring for resolution of sedation and dissociation and changes in vital signs.
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program.
    | Patient Enrollment Form |
Before administering

  • Counsel the patient on the need for monitoring for resolution of sedation and dissociation, and changes in vital signs.
  • Verify the patient is enrolled in the REMS Program through the processes and procedures established as a requirement of the REMS Program.
During and after administering, for at least 2 hours
  • Assess the patient for self-administration of Spravato and resolution of sedation and dissociation, and changes in vital signs.
After administering, within 7 calendar days
To maintain certification to dispense
At all times
  • Not dispense Spravato for use outside the certified healthcare setting.
  • Not distribute, transfer, loan, or sell Spravato.
  • Maintain records documenting staff's completion of training.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Maintain records of all shipments of Spravato received and dispensing information including patient name, dose, number of devices, and date administered.
  • Comply with audits carried out by Janssen Pharmaceuticals, Inc. or a third party acting on behalf of Janssen Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

Patients who are prescribed Spravato:

Before treatment initiation (first dose)
  • Receive counseling from a healthcare provider on risks and the need for monitoring for resolution of sedation and dissociation.
  • Enroll in the REMS Program by completing the Patient Enrollment Form with a healthcare provider. Enrollment information will be provided to the REMS Program.
    | Patient Enrollment Form |
During treatment, before each dose
  • Receive counseling from a healthcare provider on the need for monitoring for resolution of sedation and dissociation.
During treatment, during and after administration for at least 2 hours
  • Be monitored for taking Spravato, resolution of sedation and dissociation, and changes in vital signs at the healthcare setting.

Pharmacies that dispense Spravato must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
    | Pharmacy Enrollment Form |
  • Train all relevant staff involved in dispensing that Spravato must only be dispensed to a certified healthcare setting.
  • Establish processes and procedures to verify that a healthcare setting is certified in the REMS Program before dispensing Spravato.
Before dispensing
  • Verify that the healthcare setting is certified through the processes and procedures established as a requirement of the REMS Program.
At all times
  • Not distribute, transfer, loan or sell Spravato except to certified dispensers.
  • Not dispense Spravato for use outside a certified healthcare setting.
  • Maintain records documenting staff's completion of training.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Maintain records of all shipments of Spravato received and dispensing information including patient name, dose, number of devices, and date dispensed.
  • Comply with audits carried out by Janssen Pharmaceuticals, Inc. or third party acting on behalf of Janssen Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute Spravato must:

To be able to distribute
  • Establish processes and procedures to ensure that Spravato is distributed only to certified healthcare settings and certified pharmacies.
  • Train all relevant staff involved in distributing on the REMS Program requirements.
At all times
  • Distribute only to certified healthcare settings and certified pharmacies.
  • Maintain and submit records of all shipments of Spravato.
  • Comply with audits carried out by Janssen Pharmaceuticals, Inc. or a third party acting on behalf of Janssen Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Spravato REMS, see the DailyMed link(s).
Material Name Material Name Link
Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Fact_Sheet.pdf
Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Healthcare_Setting_Enrollment_Form.pdf
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Letter_for_Healthcare_Providers.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Patient_Enrollment_Form.pdf
Patient Monitoring Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Patient_Monitoring_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_Pharmacy_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Spravato_2019_06_25_REMS_Program_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
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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