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Denver Ketamine Clinic

SPRAVATO® Important Safety Information

The following is the boxed warning summary for SPRAVATO® (esketamine) CIII nasal spray, reproduced without paraphrase. For the complete Important Safety Information and Prescribing Information, including the Medication Guide, visit spravato.com.

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

Sedation and Dissociation: Patients are at risk for sedation and dissociation after administration of SPRAVATO®. Monitor patients 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.

Respiratory Depression: Respiratory depression has occurred with SPRAVATO® administration. Closely monitor vital signs, including respiration and oxygen saturation, during and after SPRAVATO® administration.

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 and monitor all patients for the development of these behaviors and conditions.

REMS: Because of the risks of sedation, dissociation, respiratory depression, and 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 behaviors in patients aged 24 years and younger in clinical studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. The safety and effectiveness of SPRAVATO® for the prevention of suicide or in reducing suicidal ideation or behavior has not been established. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted. SPRAVATO® is not approved for use in pediatric patients.

SPRAVATO® is a registered trademark of Janssen Pharmaceuticals, Inc. This page is provided for patient reference only and is not a substitute for the full Prescribing Information or a discussion with your physician.