Because of the serious risks associated with Sodium Oxybate Oral Solution, the Food and Drug Administration (FDA) has required a special program called a Risk Evaluation and Mitigation Strategy (REMS). The purpose of the REMS is to make sure that the benefits of the drug outweigh the risks. Sodium Oxybate Oral Solution is available only through a restricted distribution program called the XYWAV and XYREM REMS.
Because of the risks of central nervous system depression, abuse and misuse of this medication, Sodium Oxybate Oral Solution is available only through this restricted distribution program.
Notable requirements of the XYWAV and XYREM REMS include the following:
- Healthcare Providers who prescribe Sodium Oxybate Oral Solution are specially certified
- Sodium Oxybate Oral Solution will be dispensed only by the central pharmacy that is specially certified
- Sodium Oxybate Oral Solution will be dispensed and shipped only to patients who are enrolled in the REMS with documentation of safe use
As an authorized generic, the distribution of Sodium Oxybate Oral Solution is managed through the XYWAV and XYREM REMS program. You must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution.
