Prescriber and Patient Enrollment
The XYWAV and XYREM Risk Evaluation and Mitigation Strategy (REMS) is a program 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 risk. Because of its risks of CNS depression and abuse and misuse, XYWAV is only available through this program.1,2
For more information, please visit www.XYWAVXYREMREMS.com.
References: 1. XYWAV® (calcium, magnesium, potassium, and sodium oxybates) oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2. Risk Evaluation and Mitigation Strategies. REMS. Food and Drug Administration website. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluationand-mitigation-strategies-rems. Updated May 16, 2023. Accessed November 17, 2023.
There are 3 required forms that must be submitted to the Certified Pharmacy to complete the enrollment process and initiate the prescription:
- XYWAV and XYREM REMS Prescriber Enrollment Form
- XYWAV and XYREM REMS Patient Enrollment Form
- XYWAV Prescription Form
Once the 3 required enrollment forms above are submitted, enrollment is verified by the Certified Pharmacy for completion. Enrollment in the XYWAV and XYREM REMS is required 1 time.
For more information, please visit www.XYWAVXYREMREMS.com.
It is highly recommended that your patients enroll in JazzCares. JazzCares provides patients with access to nursing and pharmacy support, financial assistance programs for eligible patients, and resources and support tools throughout their treatment journey. Your patients can enroll via the online JazzCares Patient Authorization Form.
For more information, please watch Video 3: Insurance Matters, Video 5: Ongoing Support, or download the JazzCares Suite of Services Flashcard.
Once the patient submits the JazzCares Patient Authorization Form, the Certified Pharmacy does not require a new authorization—it is a one-time requirement.