Spravato® Important Safety Information

Spravato® (esketamine) is a prescription nasal spray. It is given only in a certified clinic, under the supervision of a healthcare provider.

Approved uses

Spravato® is not approved as an anesthetic agent, and its use does not preclude the need for hospitalization if clinically warranted.

Boxed warning

WARNING: SEDATION; DISSOCIATION; RESPIRATORY DEPRESSION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS

Sedation

Patients are at risk for sedation after administration of SPRAVATO.

Dissociation

Patients are at risk for dissociative or perceptual changes after administration of SPRAVATO.

Respiratory depression

Respiratory depression has been observed in postmarketing experience.

Because of the risks of sedation, dissociation, and respiratory depression, patients must be monitored for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.

Abuse and misuse

SPRAVATO has the potential to be abused and misused. Consider the risks and benefits of prescribing SPRAVATO prior to use in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse.

Because of the risks of serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse and misuse, SPRAVATO is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SPRAVATO REMS.

Suicidal thoughts and behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. SPRAVATO is not approved for use in pediatric patients.

At Mystic Health

Mystic Health is a certified SPRAVATO REMS treatment center. A clinician monitors you for at least two hours after every dose, and you will need someone to drive you home: you should not drive or operate machinery until the next day after a restful sleep.

If you are having thoughts of suicide, call or text 988, or call 911 in an emergency.

Full prescribing information

Read the full Prescribing Information, including the boxed warning, and the Medication Guide. More about the REMS program: www.SPRAVATOrems.com or 1‑855‑382‑6022.

Spravato® is a registered trademark of Janssen Pharmaceuticals, Inc.