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Approved Risk Evaluation and Mitigation Strategies (REMS)

Zulresso (brexanolone)
NDA #211371
REMS last update: 10/17/2023



What is the purpose of the REMS?

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:
  1. Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that provides monitoring while ZULRESSO is administered.
  2. Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
  3. 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.
  4. 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). 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
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:
  1. Update the hours of operations for the REMS call center
  2. Correcting a typographical error in the Healthcare Setting Knowledge Assessment
  3. 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.

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