The Food and Drug Administration has expanded labeling of extended-release aripiprazole lauroxil (Aristada) to allow for administration once every 2 months at a dose of 1,064 mg, for schizophrenia.
Depending on patient needs, treatment now can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1,064 mg administered every 2 months. For patients who have never taken aripiprazole, “establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability,” according to the updated labeling. The new 2-month option is expected to be available in mid-June.
Another extended-release IM aripiprazole option, (Abilify Maintena, Otsuka) is approved only for once-a-month injection.
Approval of the bimonthly dose was based on pharmacokinetic data showing long-term therapeutic aripiprazole plasma levels. Labeling did not note whether the higher dose is associated with increased adverse events. Aristada originally was approved in 2015.
As with other atypical antipsychotics, Aristada labeling notes that the drug should not be used in elderly patients with dementia because of the increased risk of fatal strokes. The labeling also warns of the possibility of tardive dyskinesia, metabolic derangements, compulsive behaviors, agranulocytosis, and other risks.