Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Zulresso (brexanolone)
NDA #211371
REMS last update: 05/17/2019



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

Healthcare settings that dispense Zulresso must:

To become certified to dispense
  • Be able to monitor patients continuously for the duration of 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 Program on behalf of the healthcare setting.
  • Have the Authorized Representative review the Training for Healthcare Settings.
    | Training for Healthcare Settings |
  • Have the Authorized Representative successfully complete the Healthcare Setting Knowledge Assessment and submit it to the REMS Program.
    | Healthcare Setting Knowledge Assessment |
  • 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 Zulresso on the REMS Program requirements using the Training for Healthcare Settings.
    | 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 program.
  • Establish processes and procedures to counsel the patient and verify the patient is enrolled in the REMS Program before administeration.
  • Establish processes and procedures to submit the Post Infusion Form and Excessive Sedation and Loss of Consciousness Adverse Event Form to the REMS Program.
    | Excessive Sedation and Loss of Consciousness Adverse Event Form | | Post Infusion Form |
Before dispensing
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program.
    | Patient Enrollment Form |
Before administering
  • Verify the patient is enrolled through the processes and procedures established as a requirement of the REMS Program.
  • 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.
    | Patient Information Guide |
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
To maintain certification to dispense
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.
    | Patient Information Guide |
  • 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 |
  • Receive counseling from a healthcare provider on the adverse event if 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 Program on behalf of the pharmacy.
  • Have the authorized representative review the Program Overview.
    | Program Overview |
  • 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 Zulresso must only be dispensed to a certified healthcare setting.
  • Establish processes and procedures to verify the healthcare setting is certified in the REMS Program.
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 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 Program 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.
  • Compy 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.

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 Zulresso REMS, see the DailyMed link(s).
Material Name Material Name Link
Excessive Sedation and Loss of Consciousness Adverse Event Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Excessive_Sedation_and_Loss_of_Consciousness_Adverse_Event_Form.pdf
Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Healthcare_Setting_Enrollment_Form.pdf
Healthcare Setting Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Healthcare_Setting_Knowledge_Assessment.pdf
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Letter_for_Healthcare_Providers.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Patient_Enrollment_Form.pdf
Patient Information Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Patient_Information_Guide.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Pharmacy_Enrollment_Form.pdf
Post Infusion Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Post_Infusion_Form.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Program_Overview.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_REMS_Program_Website_Screenshots.pdf
Training for Healthcare Settings (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zulresso_2019_05_17_Training_for_Healthcare_Settings.pdf

What updates have been made to the REMS?

Date Summary of 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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