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Important Safety Information US Full Prescribing Information, including Boxed WARNING
Important Safety Information

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Abilify Maintena® (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis. Important Safety Information Continued Below


Abilify Maintena® (aripiprazole) significantly
delayed the time to relapse* vs placebo

*Abilify Maintena significantly delayed the time to relapse vs placebo (P<0.0001) in a Phase III, 52-week,
double-blind, randomized-withdrawal clinical trial; Abilify Maintena (n=269) vs placebo (n=134).

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