SPRAVATO® Important Safety Information

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SPRAVATO®?

SPRAVATO® can cause serious side effects, including:

• Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation). Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®.
• Breathing problems (respiratory depression). Slowed or difficulty breathing can occur after taking SPRAVATO®. Your healthcare provider will monitor your breathing during and after treatment.
• Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
• SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® REMS. SPRAVATO® can only be administered at certified healthcare settings, and patients must be enrolled in the program.
• Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO® is not for use in children. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, and call your healthcare provider right away if you have new or sudden changes in mood, behavior, thoughts, or feelings.

Do not drive or operate machinery until the next day after a restful sleep.