Welcome to the XYREM® REMS Program
A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure that the benefits of the drug outweigh its risks.
This program ensures that XYREM® (sodium oxybate) is dispensed only
from the Certified Pharmacy.
Enroll in the XYREM REMS Program
The XYREM REMS Program is designed to ensure that prescribers and patients are educated on and understand the risks and safe use conditions of XYREM and agree to follow the requirements of the XYREM REMS Program.
XYREM may only be dispensed to patients enrolled in the XYREM REMS Program.
- All prescribers must enroll in the XYREM REMS Program and comply with requirements for prescribing XYREM
- All patients must be enrolled in the XYREM REMS Program to receive XYREM
- All patients are required to be counseled on the serious risks and safe use of XYREM
- XYREM will be dispensed only by the central pharmacy that is specially certified
Please call the XYREM REMS Program at 1-866-XYREM88® (1-866-997-3688) for needed assistance
Goal of the XYREM REMS
The goal of the XYREM REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of XYREM by:
Informing prescribers, pharmacists, patients, and caregivers of:
- The risk of significant CNS and respiratory depression associated with XYREM
- The contraindication of use of XYREM with sedative hypnotics and alcohol
- The potential for abuse, misuse, and overdose associated with XYREM
- The safe use, handling, and storage of XYREM
Ensuring that pharmacy controls exist prior to filling prescriptions for XYREM that:
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYREM
- Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion