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. Sedation and dissociation are the most common side effects of SPRAVATO®. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).

Breathing problems (respiratory depression). Slow or shallow breathing has happened after treatment with SPRAVATO®.

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® 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). SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS program, and to patients enrolled in the program.

Increased risk of suicidal thoughts and actions in some people. 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. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. SPRAVATO® is not for use in children.

Because of the risks for sedation, dissociation, and respiratory depression, you will need to be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when you are considered clinically stable and ready to leave the healthcare setting. Do not drive, operate machinery, or do anything where you need to be completely alert until the next day after a restful sleep.

This page reproduces the boxed-warning summary published by the manufacturer. For the complete Important Safety Information, Medication Guide, and Prescribing Information, visit spravato.com. SPRAVATO® is a registered trademark of its respective owner.

Talk with your psychiatrist about whether SPRAVATO® is appropriate for you. Questions: hello@tmstherapycenterscolorado.com.