Abstract
Aripiprazole lauroxil (AL) is a long-acting atypical antipsychotic approved for the treatment of schizophrenia in adults. AL has five regimen options that offer three different injection intervals using four different dosage strengths. The relationship between dosage strength (milligram injected), injection interval (time between injection visits), and expected steady-state plasma aripiprazole concentrations may not be readily apparent. This article illustrates the relationship by providing visual scenarios of steady-state plasma aripiprazole concentrations for the five AL regimens. The efficacy of AL was originally demonstrated in a pivotal study of two AL regimens (approved as 441mg monthly and 882mg monthly). The three additional regimens (662mg monthly, 882mg every 6weeks, and 1064mg every 2months) were approved based on pharmacokinetic bridging studies and population pharmacokinetic models. For this paper, expected steady-state concentrations for each AL regimen were derived from the published population pharmacokinetic models and compared using median values and ranges. The five labeled AL regimens differ in dosage strength and injection interval; however, model-simulated concentrations illustrate that each regimen produces steady-state plasma aripiprazole concentrations within the upper and lower bounds associated with known efficacy for AL 441mg and 882mg administered monthly. This visual presentation of the relationship between dosage strength of the AL injection, the interval between successive injections, and steady-state aripiprazole plasma concentrations may demonstrate for clinicians how dosage strength and injection interval can be considered in selecting the AL regimen option that best fits the clinical circumstances of the individual patient.
Highlights
Statement 10 of the 2020 American Psychiatric Association (APA) Practice Guideline for Treatment of Patients with Schizophrenia addresses the role of Long-acting injectable (LAI) and reads “APA suggests
This paper focuses on the LAI aripiprazole lauroxil (AL; Aristada®, Alkermes, Inc, Waltham, MA) and considers one aspect of the broader implementation challenge, the selection of an LAI
Steady-state plasma aripiprazole concentrations achieved with these two monthly regimens, characterized using population pharmacokinetic modeling in Figure 2A, represent the upper and lower bounds of the range of concentrations associated with the known efficacy of Aripiprazole lauroxil (AL) therapy
Summary
Creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. Long-acting injectable (LAI) antipsychotics provide continuous plasma antipsychotic exposure over the extended period between injections[1] and may reduce the risk of undetected medication gaps during the course of treatment.[2,3] approximately 30% or fewer outpatients with schizophrenia are prescribed LAIs, even among those considered poorly adherent.[4]. While it is beyond the scope of this paper to cover all barriers to the use of LAIs, they may include hesitation as to how to bring up the topic of LAIs using person-centered orientation, how to initiate or switch to an LAI, or how to choose a specific LAI regimen in a way that is consistent with the clinician’s approach to prescribing the oral antipsychotic counterpart.[7,8,9,10,11,12]
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