Approved Risk Evaluation and Mitigation Strategies (REMS)

Sodium Oxybate

Shared System REMS

REMS last update: 01/17/2024

Products
Goals
Summary
REMS Materials
Assessment Plan
Update history

What medicines are included in the REMS?

Product Name	Application Number	Application Holder	Added to REMS	DailyMed Link	FDA Link
sodium oxybate ( Info at Drugs@FDA )	ANDA 202090	HIKMA	01/17/2017		http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202090

What is the purpose of the REMS?

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

Informing prescribers, pharmacists, and patients of:

The risk of significant central nervous system (CNS) and respiratory depression associated with sodium oxybate
The contraindication of use of sodium oxybate with sedative hypnotics and alcohol
The potential for abuse, misuse, and overdose associated with sodium oxybate
The safe use, handling, and storage of sodium oxybate

Ensuring that pharmacy controls exist prior to filling prescriptions for sodium oxybate that:
1. Screen for concomitant use of sedative hypnotics and other potentially interacting agents
2. Monitor for inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate
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?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers).

View additional drug-specific postmarket safety information from the FDA

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
01/17/2024	Revised to make editorial changes.
12/08/2023	Modified to remove the Medication Guide as an element of the REMS, reflect a change in vendor, remove the use of electronic telecommunication to query multiple stakeholder databases, alignment of the Patient Quick Start Guide with the Instructions For Use of labeling, as well as other changes to all REMS materials to allow the REMS to be operational. Also, all REMS materials were modified to reflect the following additions to the REMS requirements: Prescribers are required to assess the patient’s potential for abuse, misuse, and diversion and to document and submit all instances of behavior that give rise to a reasonable suspicion of abuse, misuse, or diversion Pharmacies are required to verify the following by contacting all other REMS for oxybate products through the processes and procedures established as a requirement of the REMS: the patient has no other active prescriptions for oxybate products that overlap with the current prescription for sodium oxybate and the patient and prescriber have not been disenrolled from any other REMS for oxybate products for suspected abuse, misuse, or diversion Pharmacies are required to report each prescription filled for sodium oxybate to all REMS for oxybate products Applicants are required to report patient and prescriber disenrollment in the Sodium Oxybate REMS due to suspected abuse, misuse, or diversion to all other REMS for oxybate products by phone Applicants are required to maintain a process to provide certain sodium oxybate prescription information 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 Sodium Oxybate REMS for suspected abuse, misuse, or diversion
01/17/2017	Approval of the REMS.

Date

Summary of change

01/17/2024

Revised to make editorial changes.

12/08/2023

Modified to remove the Medication Guide as an element of the REMS, reflect a change in vendor, remove the use of electronic telecommunication to query multiple stakeholder databases, alignment of the Patient Quick Start Guide with the Instructions For Use of labeling, as well as other changes to all REMS materials to allow the REMS to be operational.

Also, all REMS materials were modified to reflect the following additions to the REMS requirements:

Prescribers are required to assess the patient’s potential for abuse, misuse, and diversion and to document and submit all instances of behavior that give rise to a reasonable suspicion of abuse, misuse, or diversion
Pharmacies are required to verify the following by contacting all other REMS for oxybate products through the processes and procedures established as a requirement of the REMS: the patient has no other active prescriptions for oxybate products that overlap with the current prescription for sodium oxybate and the patient and prescriber have not been disenrolled from any other REMS for oxybate products for suspected abuse, misuse, or diversion
Pharmacies are required to report each prescription filled for sodium oxybate to all REMS for oxybate products
Applicants are required to report patient and prescriber disenrollment in the Sodium Oxybate REMS due to suspected abuse, misuse, or diversion to all other REMS for oxybate products by phone
Applicants are required to maintain a process to provide certain sodium oxybate prescription information 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 Sodium Oxybate REMS for suspected abuse, misuse, or diversion

01/17/2017

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.