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The goal of the ZULRESSO REMS Program is to mitigate the risk of serious harm resulting from excessive
sedation and sudden loss of consciousness during the ZULRESSO infusion by:
Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that
provides monitoring while ZULRESSO is administered.
Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
Ensuring that each patient is informed of the adverse events of excessive sedation and loss of
consciousness and the need for monitoring while ZULRESSO is administered.
Enrollment of all patients in a registry to 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).
Be able to monitor patients continuously for the duration of the
infusion.
Have the following onsite: continuous pulse oximetry, fall
precaution protocol, intravenous programmable infusion
pumps with alarms to alert when the pump malfunctions,
healthcare providers to continuously monitor patients and
intervene as necessary.
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 Training for
Healthcare Settings.
Have the Authorized Representative successfully complete the
Healthcare Setting Knowledge Assessment and submit it to the
REMS.
Have the Authorized Representative enroll in the REMS by
completing the Healthcare Setting Enrollment Form and
submitting it to the REMS.
Train all relevant staff involved in prescribing, dispensing, and
administering ZULRESSO on the REMS requirements using the
Training for Healthcare Settings.
Establish processes and procedures to identify new staff
involved in prescribing, dispensing, and administering
ZULRESSO and ensure they are trained.
Establish processes and procedures to enroll the patient in the
REMS.
Establish processes and procedures to counsel the patient and
verify the patient is enrolled in the REMS before
administration.
Establish processes and procedures to submit the Post Infusion
Form and Excessive Sedation and Loss of Consciousness
Adverse Event Form to the REMS.
Before dispensing
Enroll the patient by completing and submitting the Patient
Enrollment Form to the REMS.
Before administering
Verify the patient is enrolled through the processes and
procedures established as a requirement of the REMS.
Counsel the patient on signs and symptoms of excessive
sedation, loss of consciousness, and the importance of
immediately reporting to a healthcare provider any signs and
symptoms of excessive sedation using the Patient Information
Guide. Provide a copy of the material to the patient.
During treatment, every
2 hours
Assess the patient’s health status for signs and symptoms of
excessive sedation and loss of consciousness.
During treatment
Assess the patient’s oxygen saturation using continuous pulse
oximetry.
After treatment
discontinuation, prior to
discharge
Assess the patient’s level of sedation.
After treatment
discontinuation, within 3
business days of
completion date
Document and submit to the REMS using the Post Infusion
Form.
Report excessive sedation or loss of consciousness to the
REMS using the Excessive Sedation and Loss of Consciousness
Adverse Event Form.
To maintain certification
to dispense
Have any new Authorized Representative enroll in the REMS by
successfully completing the Healthcare Setting Knowledge
Assessment and the Healthcare Setting Enrollment Form and
submitting both to the REMS.
At all times
Not distribute, transfer, loan, or sell ZULRESSO.
Maintain records documenting staff’s completion of training.
Maintain records that all REMS processes and procedures are
in place and are being followed.
Maintain records of all shipments of ZULRESSO received and
dispensing information including patient name, dose, number
of vials, and date administered for all patients.
Comply with audits carried out by Sage Therapeutics, Inc. or
third party acting on behalf of Sage Therapeutics, Inc. to
ensure that all processes and procedures are in place and are
being followed.
Patients who are prescribed ZULRESSO:
Before treatment
initiation
Review the Patient Information Guide with a healthcare
provider.
Enroll in the REMS by completing the Patient Enrollment Form
with a healthcare provider. Enrollment information will be
provided to the REMS.
Receive counseling from a healthcare provider on the adverse
events of loss of consciousness and signs and symptoms of
excessive sedation.
During treatment
Be monitored for excessive sedation and loss of consciousness.
Report any symptoms of excessive sedation to a healthcare
provider.
Pharmacies that dispense ZULRESSO 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 review the Program
Overview.
Have the authorized representative enroll in the REMS by
completing the Pharmacy Enrollment Form and submitting it to
the REMS.
Train all relevant staff involved in dispensing that ZULRESSO
must only be dispensed to a certified healthcare setting.
Establish processes and procedures to verify the healthcare
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 ZULRESSO.
Maintain records documenting staff’s completion of training.
Maintain records that all REMS processes and procedures are
in place and are being followed.
Maintain records of all shipments of ZULRESSO received and
dispensing information including patient name, dose, and
number of vials.
Comply with audits carried out by Sage Therapeutics, Inc. or
third party acting on behalf of Sage Therapeutics to ensure
that all processes and procedures are in place and are being
followed.
Wholesalers-distributors that distribute ZULRESSO must:
To be able to distribute
Establish processes and procedures to distribute only to
certified healthcare settings and pharmacies.
Train all relevant staff involved in distributing on the REMS
requirements.
At all times
Distribute only to certified healthcare settings and pharmacies.
Maintain records of drug distribution.
Maintain records that all processes and procedures are in place
and are being followed.
Comply with audits carried out by Sage Therapeutics, Inc. or a
third party acting on behalf of Sage Therapeutics, Inc. to
ensure all processes and procedures are in place and 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
01/23/2025
Modified to update the REMS website to include a prominent static banner on the landing
page containing the following statement: “As of January 1, 2025, ZULRESSO
(brexanolone) will no longer be commercially available in the U.S.”
10/09/2024
Revised to change the application holder's address
10/17/2023
Modified to change the number of certified healthcare settings and certified pharmacies eligible for audits to all certified healthcare settings and certified pharmacies no later than 90 days after they have placed the first order for Zulresso, limiting the annual audits to only those certified settings that have ordered Zulresso in the previous 12 months, modifying the internal audit schedule, and changes to the REMS document to align with the Format and Content of a REMS Document Guidance for Industry 2023 and the REMS Document Technical Conformance Guide 2023.
03/03/2023
Modified to:
Update the hours of operations for the REMS call center
Correcting a typographical error in the Healthcare Setting Knowledge Assessment
Require healthcare provider username and password for electronic submission of Post Infusion Form and
Excessive Sedation and Loss of Consciousness Adverse Event Form
06/16/2022
Modified to provide for expansion of the indication to include patients 15 years and older diagnosed with postpartum depression and addition of corresponding study information to
applicable sections of REMS materials.
10/14/2020
Revised to make editorial changes.
12/13/2019
Modified to revise language in the REMS document and materials to allow for online capabilities for enrollment,verification, training, and submission of both the Post Infusion Form and the Excessive Sedation
and Loss of Consciousness Adverse Event Form, adding a field on the Post Infusion Form to collect the reason why an enrolled patient did not receive Zulresso, revising language in the
REMS document to specify that certified healthcare settings and certified pharmacies will be audited no later than 90 calendar days after they have placed the first order rather than after
certification, and minor editorial changes throughout the REMS materials.
09/30/2019
Modified to align language across REMS materials, adds a field to collect a DEA number on the Healthcare Setting Enrollment Form and Pharmacy Enrollment Form (following scheduling of Zulresso), adds a field to capture the scheduled infusion start date, and includes minor editorial changes.
06/17/2019
Revised to make an editorial change.
05/17/2019
Modified to align the pregnancy information in the Zulresso REMS materials (Patient Information Guide and Training for Healthcare Settings) with the approved Prescribing Information (PI) and Medication Guide (MG).
03/19/2019
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.
