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Spravato medication guide HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRAVATO safely and e ?ectively See full prescribing information for SPRAVATO SPRAVATO esketamine nasal spray CIII Initial U

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRAVATO safely and e ?ectively See full prescribing information for SPRAVATO SPRAVATO esketamine nasal spray CIII Initial U S Approval ketamine WARNING SEDATION DISSOCIATION ABUSE AND MISUSE and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning Risk for sedation and dissociation after administration Monitor patients for at least two hours after administration Potential for abuse and misuse Consider the risks and bene ?ts of prescribing SPRAVATO prior to using in patients at higher risk of abuse Monitor patients for signs and symptoms of abuse and misuse SPRAVATO is only available through a restricted program called the SPRAVATO REMS Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants Closely monitor all antidepressant- treated patients for clinical worsening and emergence of suicidal thoughts and behaviors SPRAVATO is not approved for use in pediatric patients -----------------------------INDICATIONS AND USAGE--------------------------SPRAVATO is a non-competitive N-methyl D-aspartate NMDA receptor antagonist indicated in conjunction with an oral antidepressant for the treatment of treatment-resistant depression TRD in adults Limitations of Use SPRAVATO is not approved as an anesthetic agent The safety and e ?ectiveness of SPRAVATO as an anesthetic agent have not been established ------------------------DOSAGE AND ADMINISTRATION---------------------- ? Administer SPRAVATO intranasally under the supervision of a healthcare provider ? Assess blood pressure prior to and after administration ? Evidence of therapeutic bene ?t should be evaluated at the end of the induction phase to determine need for continued treatment ? See Full Prescribing Information for recommended dosage during the induction and maintenance phases FULL PRESCRIBING INFORMATION CONTENTS WARNING SEDATION DISSOCIATION ABUSE AND MISUSE SUICIDAL THOUGHTS AND BEHAVIORS INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION Important Considerations Prior to Initiating and During Therapy Recommended Dosage Administration Instructions Post-Administration Observation Missed Treatment Session s DOSAGE FORMS AND STRENGTHS CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Sedation Dissociation Abuse and Misuse SPRAVATO Risk Evaluation and Mitigation Strategy REMS Suicidal Thoughts and Behaviors in Adolescents and Young Adults Increase in Blood Pressure Cognitive Impairment Impaired Ability to Drive and Operate Machinery Ulcerative or Interstitial Cystitis Embryo-fetal Toxicity ADVERSE REACTIONS Clinical Trials Experience DRUG INTERACTIONS Central Nervous System Depressants Psychostimulants ? See Full Prescribing Information for important administration instructions ----------------------DOSAGE FORMS AND STRENGTHS --------------------Nasal Spray mg of esketamine per device Each nasal spray device delivers two sprays containing a total of mg of esketamine ----------------------------- CONTRAINDICATIONS -------------------------------- ? Aneurysmal vascular disease including thoracic and abdominal aorta intracranial and peripheral arterial vessels or arteriovenous malformation ? Intracerebral hemorrhage ? Hypersensitivity to esketamine ketamine or any of the excipients -------------------------WARNINGS AND PRECAUTIONS --------------------- ? Increases in Blood Pressure Patients with cardiovascular and cerebrovascular conditions and risk factors may be at an increased risk of associated adverse e ?ects ? Cognitive Impairment SPRAVATO may impair attention judgment thinking reaction speed and motor skills ? Impaired Ability to Drive and Operate Machinery Do not drive or operate machinery until the next day after a restful sleep ?