On February 9, 2022, Jazz Pharmaceuticals plc made changes to its XYWAV and XYREM prescription forms to decrease prescriber confusion when documenting the indication for use and signing the form.
On December 9, 2021, Jazz made changes to the dosing table structure on the Xywav Prescription Form to prevent confusion when the prescriber fills out the form.
The prescription forms are available at https://xywavxyremrems.com.
The goal of the XYWAV and XYREM Risk Evaluation and Mitigation Strategies (REMS) is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM by:
- Informing prescribers, pharmacists, and patients of:
- The risk of significant CNS and respiratory depression associated with XYWAV and XYREM.
- The contraindication of use of XYWAV and XYREM with sedative hypnotics and alcohol.
- The potential for abuse, misuse, and overdose associated with XYWAV and XYREM.
- The safe use, handling, and storage of XYWAV and XYREM.
- Ensuring that pharmacy controls exist prior to filling prescriptions for XYWAV and XYREM that:
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents.
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM.
- Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion.