Approved Risk Evaluation and Mitigation Strategies (REMS)

Lumryz (sodium oxybate extended-release)

NDA #214755

REMS last update: 10/31/2023

• View the Lumryz Prescribing Information and Medication Guide at DailyMed.
• View Lumryz's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the LUMRYZ REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of LUMRYZ by:

1. Informing prescribers, pharmacists, and patients of:

1. The risk of significant central nervous system (CNS) and respiratory depression associated with LUMRYZ
2. The contraindication of use of LUMRYZ with sedative hypnotics or alcohol
3. The potential for abuse, misuse, and overdose associated with LUMRYZ
4. The safe use, handling, and storage of LUMRYZ

2. Ensuring that pharmacy controls exist prior to filling prescriptions for LUMRYZ that:

1. Screen for concomitant use of sedative hypnotics and other potentially interacting agents
2. Monitor for inappropriate prescribing, misuse, abuse, and diversion of LUMRYZ
3. Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion

What do participants need to know?

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
10/31/2023	Modifications to the REMS consist of: updates to the REMS Document to align with the current Format and Content of a REMS Document Guidance for Industry and the REMS Document Technical Conformance Guide; changes to the reporting of the confirmation for prescriptions filled for Lumryz to the REMS; and changes to the Lumryz Prescription Form to comply with certain state requirements for paper prescriptions. Additionally, all REMS materials are aligned to the following changes to the REMS requirements: Prescribers are required to document and submit all instances of behavior that give rise to a reasonable suspicion of abuse, misuse, or diversion; and report requests to disenroll a patient for suspected abuse, misuse, or diversion to the REMS using the Risk Management Report. Pharmacies are required to obtain oxybate prescription information of last dispense date, days’ supply, and prescriber’s name by contacting all other REMS for oxybate products. Changes to the REMS Dispense Authorization (RDA) to include that the Patient Counseling Checklist is completed as required and the alerts and Risk Management Report history for the patient and their prescriber are reviewed by the pharmacist. The Applicant is required to ensure prescribers are able to access patient alerts and Risk Management Report histories. The Applicant is required to maintain a process to provide Lumryz prescription information, including last dispense date, days’ supply, and prescriber’s name to other pharmacies upon request to verify that the named patient has no other active, overlapping prescriptions for oxybate products and that the patient and prescriber have not been disenrolled from the Lumryz REMS for suspected abuse, misuse, or diversion.
05/01/2023	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.