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Under the direct supervision of a healthcare provider, SPRAVATO is self-administered twice a week during weeks 1-4 in the induction phase, followed by maintenance treatment once weekly during weeks 5-8, and then every 2 weeks or once weekly from week 9 forward.

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.

Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program.

What is the SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy)? A REMS is a strategy to manage known or potential risks associated with a drug and is required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

SPRAVATO® can fall under the medical or pharmacy benefit depending on your coverage, so it's important to ask and relay this to your healthcare provider.

information listed, please call SPRAVATO® REMS at 1-855-382-6022. Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO® to Janssen at 1-800-JANSSEN (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at .fda.gov/medwatch.

Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program.