Approved Risk Evaluation and Mitigation Strategies (REMS)
Lumryz (sodium oxybate extended-release)
NDA #214755
REMS last update: 10/31/2023
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:- The risk of significant central nervous system (CNS) and respiratory depression associated with LUMRYZ
- The contraindication of use of LUMRYZ with sedative hypnotics or alcohol
- The potential for abuse, misuse, and overdose associated with LUMRYZ
- The safe use, handling, and storage of LUMRYZ
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of LUMRYZ
- 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 |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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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: |
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.