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FDA Date: 7/15/15
Xyrem (sodium oxybate) Oral Solution REMS
Goal of the Xyrem (sodium oxybate) Oral Solution REMS Program
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:
A. Informing prescribers, pharmacists, and patients of:
1. The risk of significant CNS and respiratory depression associated with XYREM
2. The contraindication of use of XYREM with sedative hypnotics and alcohol
3. The potential for abuse, misuse, and overdose associated with XYREM
4. The safe use, handling, and storage of XYREM
B. Ensuring that pharmacy controls exist prior to filling prescriptions for XYREM that:
1. Screen for concomitant use of sedative hypnotics and other potentially interacting agents
2. Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYREM
3.Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion.
• Medication Guide
• Elements to Assure Safe Use
• Implementation System