WARNINGS AND PRECAUTIONS ----------------

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HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------- WARNINGS AND PRECAUTIONS ---------------------------------- These highlights do not include all the information needed to use CAPLYTA safely Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: and effectively. See full prescribing information for CAPLYTA. Increased incidence of cerebrovascular adverse reactions ( , stroke and transient CAPLYTA (lumateperone) capsules, for oral use ischemic attack). ( ). Initial Approval: 2019 Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( ). WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH Tardive Dyskinesia: Discontinue treatment if clinically appropriate. ( ). DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and See full prescribing information for complete boxed warning.

Boxed Warning 12/2021 Indication and Usage (1) 12/2021 Dosage and Administration (2.1) 12/2021 Warnings and Precautions (5.2, 5.6, 5.8, 5.11) 12/2021 ... Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with ... especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family ...

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