HEALTH AND WELLNESS
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.* Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
* How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?* Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
* Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
* Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
* Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
* suicide attempts
* worsening depression
* thoughts about suicide or dying
* other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
* have blood vessel (aneurysmal vascular) disease (including in the brain,
* Respiratory depression was observed with the use of SPRAVATO®; additionally, there were rare reports of respiratory arrest.* Your healthcare provider must monitor you for serious side effects for at least 2 hours (including pulse oximetry) after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
* 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®.* Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
* Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
* 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. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
* Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions