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FDA Approves New Dosing Regimen for Treatment of Schizophrenia


June 06, 2017

The US Food and Drug Administration (FDA) has approved a new 2-month dose for Aristada (aripiprazole lauroxil; Alkermes) extended-release injectable suspension for the treatment of patients diagnosed with schizophrenia.

Aristada, an injectable atypical antipsychotic, is now available in 4 doses with 3 dosing duration options, including 441 mg, 662 mg or 882 mg once monthly, 882 mg once every 6 weeks and 1064 mg once every 2 months. It should be administered by a health care professional, and it can be initiated at any dose or interval, allowing for a range of flexibility to patients and providers. The newly approved 2-month treatment allows patients living with schizophrenia an option to treat their symptoms with only 6 injections per year which eliminates the burden of taking an oral antipsychotic daily.

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The most common adverse event reported among patients was akathisia. Additional reported reactions included an increased risk for developing neuroleptic malignant syndrome, tardive dyskinesia, pathological gambling or other compulsive behaviors, orthostatic hypotension, leukopenia, neutropenia, and agranulocytosis. Some patients experienced metabolic changes including, hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain.

Further, an increased incidence of cerebrovascular adverse reactions including stroke, transient ischemic attacks, and falls have been reported in elderly patients with dementia-related psychosis.

Julie Gould (Mazurkiewicz)

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