Because of the risks associated with SPRAVATO®, the Food and Drug Administration (FDA) has required a special program called a Risk Evaluation and Mitigation Strategy (REMS). As part of the REMS, your healthcare provider will discuss the risks of misuse, abuse, sedation (feeling sleepy), dissociation (feeling disconnected from yourself, including thoughts, feelings, and things around you) while on SPRAVATO® with you. Both you and your healthcare provider must sign the Patient Enrollment Form for you to receive SPRAVATO® in an outpatient medical office or clinic, excluding emergency departments. Your healthcare provider will provide a copy of the signed form to the SPRAVATO® REMS.
If your healthcare provider and you have both agreed that SPRAVATO® is the appropriate treatment for you, you will need to enroll in the SPRAVATO® REMS in order to receive treatment with SPRAVATO® in an outpatient medical office or clinic, excluding emergency departments.