Transcription of PATIENT COUNSELING INFORMATION - aristada.com
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PATIENT COUNSELING INFORMATION - aristada.com
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the INFORMATION needed to use ARISTADA INITIO safely and effectively. See full prescribing INFORMATION for ARISTADA INITIO . ARISTADA INITIO (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use Initial Approval: 2015 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing INFORMATION for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ( ) ARISTADA INITIO is not approved for the treatment of patients with dementia-related psychosis. ( ) _____ INDICATIONS AND USAGE _____ ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults ( 1). _____ DOSAGE AND ADMINISTRATION _____ Administer one 675 mg injection of ARISTADA INITIO and one 30 mg dose of oral aripiprazole in conjunction with the first ARISTADA injection ( ).
• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. (5.1) • ARISTADA INITIO is not approved for the treatment of …
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