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

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.

In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke.

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