Oral Aripiprazole Dosing When Initiating Abilify Maintena
When initiating Abilify Maintena 400 mg intramuscularly, administer oral aripiprazole 10-20 mg daily for 14 consecutive days starting on the same day as the first injection. 1
Rationale for Oral Supplementation
The 14-day oral overlap is necessary because aripiprazole once-monthly (AOM) takes time to reach therapeutic plasma concentrations after the initial injection:
- Pharmacokinetic data demonstrate that median aripiprazole plasma concentrations reach therapeutic levels within 7 days of the first AOM 400 mg injection 1
- However, due to significant interpatient variability in absorption and metabolism, a 14-day overlap with oral aripiprazole is considered sufficient to ensure therapeutic concentrations are maintained in all patients 1
- Aripiprazole has a long elimination half-life (approximately 75 hours for aripiprazole and 94 hours for its active metabolite dehydroaripiprazole), and steady-state concentrations require 14 days of dosing 2
Specific Oral Dosing Recommendations
The oral aripiprazole dose during the 14-day overlap should be 10-15 mg daily, based on the patient's previously stabilized oral dose 1:
- Patients previously stabilized on oral aripiprazole 10 mg should continue 10 mg daily for 14 days
- Patients previously stabilized on oral aripiprazole 15-30 mg should receive 10-15 mg daily for 14 days
- The therapeutic range for oral aripiprazole is 10-30 mg/day 2
Alternative: Continuing Previous Antipsychotic
If the patient is switching from a different antipsychotic (not oral aripiprazole), continue their previous antipsychotic medication for the first 14 days after initiating AOM 400 1. This approach was used successfully in clinical trials and maintains therapeutic coverage during the transition period 1.
Cross-Titration Strategy When Switching
When switching from another oral antipsychotic to AOM 400, taper the prior oral antipsychotic while titrating up oral aripiprazole (target dose 10-30 mg/day) over more than 1 to 4 weeks before initiating the first AOM injection 1. This gradual cross-titration approach:
- Results in lower discontinuation rates due to adverse events (2.7% vs 10.4% with rapid ≤1-week cross-titration) 1
- Allows assessment of tolerability to oral aripiprazole before committing to the long-acting formulation
- Permits dose optimization during the oral phase
Clinical Evidence Supporting This Approach
In clinical studies, when patients initiated AOM 400 with concomitant oral aripiprazole (10-15 mg/day) or continued their previous antipsychotic for ≤14 days, mean aripiprazole plasma concentrations after 4 weeks (93-112 ng/mL) were within the established therapeutic window (94.0-534.0 ng/mL) 1.
Across multiple clinical studies, 90.1% of patients (1296/1439) initiated AOM 400 and required no dose change, with low discontinuation rates due to lack of efficacy (2.3%-10.0%) 1, supporting that 400 mg is the appropriate starting dose with proper oral supplementation.