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The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and
dissociation and respiratory depression caused by SPRAVATO administration, and abuse and misuse of
SPRAVATO.
Objectives:
Patients are monitored for at least two hours and until resolution of sedation, dissociation and
respiratory depression
Patients are aware of the serious adverse outcomes resulting from sedation, dissociation and
respiratory depression and the requirement for monitoring
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).
Healthcare settings that dispense SPRAVATO for outpatient use must:
To become certified to
dispense
Have a prescriber onsite during SPRAVATO administration and
monitoring.
Have healthcare provider(s) and a pulse oximeter to monitor
patients onsite.
Designate an authorized representative to carry out the
certification process, oversee implementation and compliance
with the REMS on behalf of the healthcare setting.
Have the authorized representative review the SPRAVATO
prescribing information and REMS Program Overview.
Have the authorized representative enroll in the REMS by
completing the Outpatient Healthcare Setting Enrollment Form and
submitting it to the REMS.
Establish processes and procedures to enroll the patient in the
REMS.
Establish processes and procedures to counsel the patient on the
requirement for enrollment, monitoring, and risks of sedation and
dissociation, respiratory depression and other changes in vital signs and the need to have arrangements to safely leave the healthcare
setting and not engage in potentially hazardous activities.
Establish processes and procedures to verify the patient is
enrolled in the REMS 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.
Train all relevant staff involved in prescribing, dispensing and
administering SPRAVATO on 1) Counseling the patient on the
requirement for monitoring and risks of sedation, dissociation,
respiratory depression and other changes in vital signs, and
the need to have arrangements to safely leave the healthcare
setting and not engage in potentially hazardous activities; 2)
Patient administration under the supervision of a healthcare
provider; and 3) Monitoring for resolution of sedation,
dissociation, and respiratory depression using pulse oximetry,
and other changes in vital signs for a minimum of 2 hours.
Establish processes and procedures to identify all staff involved
in prescribing, dispensing, and administering SPRAVATO and
ensure they are trained on 1) Counseling the patient on the
requirement for monitoring and risks of sedation, dissociation,
respiratory depression and other changes in vital signs, and
the need to have arrangements to safely leave the healthcare
setting and not engage in potentially hazardous activities; 2)
Patient administration under the supervision of a healthcare
provider; 3) Monitoring for resolution of sedation, dissociation,
respiratory depression using pulse oximetry, and other
changes in vital signs for a minimum of 2 hours.
Before treatment
initiation (first dose)
Counsel the patient on the risks and requirement for
monitoring for resolution of sedation, dissociation, respiratory
depression and other changes in vital signs and the need to
have arrangements to safely leave the healthcare setting and
not engage in potentially hazardous activities.
Enroll the patient by completing and submitting the Patient
Enrollment Form to the REMS.
Before administering
Counsel the patient on the requirement for monitoring for
resolution of sedation, dissociation, respiratory depression and
other changes in vital signs and the need to have
arrangements to safely leave the healthcare setting and not
engage in potentially hazardous activities.
Verify the patient is enrolled in the REMS through the processes
and procedures established as a requirement of the REMS.
During and after
administering, for at
least 2 hours
Assess the patient for administration of SPRAVATO and
resolution of sedation, dissociation, respiratory depression
using pulse oximetry, and other changes in vital signs.
After administering,
within 7 calendar days
Document and submit to the REMS using the Patient
Monitoring Form.
To maintain certification
to dispense
Have any new authorized representative enroll in the REMS by
completing the Outpatient Healthcare Setting Enrollment Form.
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.
Healthcare settings that dispense SPRAVATO for inpatient use (including emergency
departments within certified healthcare settings) must:
To become certified to
dispense
Have a prescriber onsite during SPRAVATO administration and
monitoring.
Have healthcare provider(s) and a pulse oximeter to monitor
patients onsite.
Designate an authorized representative to carry out the
certification process and oversee implementation and
compliance with the REMS on behalf of the healthcare setting.
Have the authorized representative review the SPRAVATO
prescribing information and REMS Program Overview.
Have the authorized representative enroll in the REMS by
completing and submitting the Inpatient Healthcare Setting
Enrollment Form.
Establish processes and procedures to counsel the patient on the
requirement for monitoring, risks of sedation, dissociation,
respiratory depression and other changes in vital signs and the
need to have arrangements to safely leave the healthcare setting
and not engage in potentially hazardous activities.
Establish processes and procedures to verify SPRAVATO is not
dispensed for use outside the certified healthcare setting.
Train all relevant staff involved in prescribing, dispensing and
administering SPRAVATO on 1) Counseling the patient on the
requirement for monitoring, risks of sedation, dissociation,
respiratory depression and other changes in vital signs, and the
need to have arrangements to safely leave the healthcare setting
and not engage in potentially hazardous activities; 2) Patient
administration under the supervision of a healthcare provider; and
3) Monitoring for resolution of sedation, dissociation, respiratory depression using pulse oximetry and other changes in vital signs
for a minimum of 2 hours.
Before administering
Counsel the patient on the requirement for monitoring for
resolution of sedation, dissociation, respiratory depression and
other changes in vital signs, and the need to have
arrangements to safely leave the healthcare setting and not
engage in potentially hazardous activities.
During and after
administering, for at
least 2 hours
Assess the patient for administration of SPRAVATO and
resolution of sedation, dissociation, respiratory depression
using pulse oximetry, and other changes in vital signs.
To maintain certification
to dispense
Have any new authorized representative enroll in the REMS by
completing the Inpatient Healthcare Setting Enrollment Form.
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
requirement for monitoring for resolution of sedation,
dissociation, respiratory depression and other changes in vital
signs and the need to have arrangements to safely leave the
healthcare setting and not engage in potentially hazardous
activities.
For outpatients: Enroll in the REMS by completing the Patient
Enrollment Form with a healthcare provider. Enrollment information
will be provided to the REMS.
During treatment,
before each dose
Receive counseling from a healthcare provider on the requirement
for monitoring for resolution of sedation, dissociation, respiratory
depression, and other changes in vital signs and the need to have
arrangements to safely leave the healthcare setting and not engage
in potentially hazardous activities.
During treatment,
during and after
administration for at
least 2 hours
Be monitored for taking SPRAVATO, resolution of sedation,
dissociation, respiratory depression and other 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
on behalf of the pharmacy.
Have the authorized representative enroll in the REMS by completing
the Pharmacy Enrollment Form and submitting it to the REMS.
Establish processes and procedures to verify that a healthcare
setting is certified in the REMS before dispensing SPRAVATO.
Train all relevant staff involved in dispensing that SPRAVATO must
only be dispensed to a certified healthcare setting.
Before dispensing
Verify that the healthcare setting is certified through the processes
and procedures established as a requirement of the REMS.
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
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.
Assessment Plan
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
12/31/2024
Modified to add the risk of respiratory depression to align with the Safety Labeling Changes approved on October 18, 2023.
Healthcare settings are required to have a pulse oximeter to monitor patients onsite.
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.
