What is the recommended dosing for Aristada (aripiprazole) in schizophrenia treatment?

Aristada (Aripiprazole Lauroxil) Dosing for Schizophrenia

Aristada is available in multiple dosing regimens: 441 mg monthly, 662 mg monthly, 882 mg monthly or every 6 weeks, and 1064 mg every 2 months, all administered as intramuscular injections. 1, 2

Available Dose Regimens

• Monthly (every 4 weeks) options: 441 mg, 662 mg, or 882 mg 1
• Every 6 weeks: 882 mg 1
• Every 2 months (every 8 weeks): 1064 mg 2

All approved dosing regimens provide continuous therapeutic aripiprazole exposure throughout their respective dosing intervals and have demonstrated comparable efficacy. 2

Initiation Strategies

Two initiation options are available when starting Aristada:

21-Day Initiation Regimen

• Requires 21 consecutive days of oral aripiprazole supplementation when starting Aristada 3
• This traditional approach ensures therapeutic aripiprazole concentrations are achieved while the long-acting formulation reaches steady state 3

1-Day Initiation Regimen (Preferred for Rapid Initiation)

• Utilizes a single injection of aripiprazole lauroxil nano-crystalline dispersion (ALNCD) plus one 30 mg oral aripiprazole dose 3
• Achieves therapeutic aripiprazole concentrations within 4 days, equivalent to the 21-day regimen 3
• Compatible with all approved Aristada dosing regimens (441,662,882 mg monthly; 882 mg every 6 weeks; 1064 mg every 2 months) 3
• Allows a window of up to 10 days between the 1-day initiation and the first Aristada injection while maintaining therapeutic concentrations 3

Dose Selection Considerations

The effective dose range for aripiprazole in schizophrenia is 10-25 mg/day equivalent. 4

• The 441 mg monthly and 662 mg monthly regimens provide lower steady-state aripiprazole concentrations 2
• The 882 mg (monthly or every 6 weeks) and 1064 mg (every 2 months) regimens provide higher, comparable steady-state concentrations 2
• For acute symptom control, higher doses (equivalent to 15-28 mg/day oral aripiprazole) demonstrate optimal efficacy 4
• For agitation specifically, lower doses may be sufficient 4

Treatment Duration and Assessment

Each antipsychotic trial should last at least 4-6 weeks at therapeutic doses to properly assess efficacy. 5, 6

• If significant positive symptoms persist after 4 weeks at therapeutic doses with good adherence, switching to an alternative antipsychotic should be discussed 5
• After failure of two adequate antipsychotic trials (each lasting at least 4-6 weeks at therapeutic doses), clozapine should be considered 5, 6

Managing Missed Doses

ALNCD can be used to re-establish therapeutic aripiprazole concentrations when an Aristada dose is delayed. 3

• Coadministration of a delayed Aristada injection with a single ALNCD injection rapidly restores therapeutic concentrations 3
• If the first Aristada injection is given up to 10 days after the 1-day initiation regimen, median aripiprazole concentrations remain ≥77% of those achieved with same-day administration 3

Safety Profile

Aristada demonstrates a favorable metabolic profile with low propensity for weight gain, consistent with oral aripiprazole. 1, 7

• Injection-site reactions are the primary adverse event distinguishing Aristada from oral aripiprazole, occurring in 8.6-11.4% of patients 2
• Extrapyramidal symptoms (akathisia, dyskinesia, dystonia) occur at rates comparable to other formulations of aripiprazole 2
• Low risk for metabolic disturbances, hyperprolactinemia, and QT prolongation 1, 7