Spravato rems patient monitoring form 2025

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In postmarketing safety data from the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) and the SPRAVATO global medical safety databases from 5 March 2019 to 5 January 2023, suicidal ideation was reported in 10.2% (249/2437) of serious adverse events and 47 deaths were reported due to completed suicides.
Administer SPRAVATO in conjunction with an oral AD. The recommended dosage of SPRAVATO for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior is 84 mg twice per week for 4 weeks. Dosage may be reduced to 56 mg twice per week based on tolerability.
Enroll in the SPRAVATO REMS by completing this Patient Enrollment Form with my healthcare provider. Enrollment information will be submitted to the SPRAVATO REMS. Receive counseling on safety risks and the need for monitoring to observe for resolution of sedation and dissociation, and for any changes in vital signs.
SPRAVATO is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO must never be dispensed directly to a patient for home use.
SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression, and abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program.
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SPRAVATO can only be administered at healthcare settings certified in the SPRAVATO REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program.

spravato rems monitoring form