What is the recommended dosing regimen for Abilify (aripiprazole) Maintena 400mg?

Abilify Maintena 400mg Dosing

Abilify Maintena 400mg is administered as a single intramuscular injection once monthly (every 4 weeks), with a mandatory 14-day overlap of oral aripiprazole (10-20mg daily) or continuation of the previous antipsychotic after the first injection to ensure therapeutic plasma concentrations are maintained. 1

Standard Dosing Regimen

• Starting dose: 400mg intramuscularly once monthly 1
• Maintenance dose: 400mg intramuscularly once monthly (no dose adjustment needed for most patients) 1
• Injection site: Administered as deep intramuscular injection in the deltoid or gluteal muscle 1

Critical Oral Overlap Requirement

The 14-day oral supplementation period after the first injection is non-negotiable because aripiprazole plasma concentrations take approximately 7 days to reach therapeutic levels (median time), though interpatient variability necessitates the full 2-week overlap for safety. 1

• Continue oral aripiprazole 10-20mg daily for 14 days after the first Abilify Maintena injection 1
• Alternatively, continue the patient's previous antipsychotic medication for 14 days if switching from another agent 1
• After the second and subsequent injections, no oral supplementation is required 1

Dose Selection and Adjustments

The 400mg dose is appropriate for virtually all patients regardless of their previous oral aripiprazole dose. Clinical trial data demonstrate that 90.1% (1,296/1,439) of patients initiated on 400mg required no dose changes throughout treatment. 1

• Patients previously stabilized on oral aripiprazole 10mg daily: Use 400mg monthly 1
• Patients previously stabilized on oral aripiprazole 30mg daily: Use 400mg monthly 1
• No dose titration is needed - start directly at 400mg 1

The efficacy and safety profiles were comparable between patients previously on low-dose (10mg) versus high-dose (30mg) oral aripiprazole, supporting 400mg as the universal starting dose. 1

Switching from Other Antipsychotics

When transitioning from non-aripiprazole antipsychotics to Abilify Maintena, a gradual cross-titration over more than 1 to 4 weeks significantly improves tolerability compared to rapid switches. 1

• Optimal approach: Taper the prior oral antipsychotic while simultaneously titrating oral aripiprazole up to 10-30mg daily over >1 to 4 weeks 1
• Once stabilized on oral aripiprazole, administer the first Abilify Maintena 400mg injection 1
• Continue oral aripiprazole for 14 days after the first injection 1

Post-hoc analysis revealed that cross-titration periods >1 to 4 weeks resulted in only 2.7% discontinuation due to adverse events, compared to 10.4% with rapid (≤1 week) switches. 1

Pharmacokinetic Considerations

• Time to steady state: Therapeutic aripiprazole plasma concentrations (94.0-534.0 ng/mL) are achieved within 4 weeks of the first injection 1
• Mean plasma concentration at 4 weeks: 93-112 ng/mL, which falls within the established therapeutic window 1
• Elimination half-life: Approximately 30-47 days for the long-acting formulation, supporting monthly dosing 1

Clinical Efficacy Data

Discontinuation rates due to lack of efficacy were consistently low across clinical trials (range 2.3%-10.0%), supporting the adequacy of the 400mg dose for most patients. 1

Common Pitfalls to Avoid

• Do not skip the 14-day oral overlap - this is the most critical error that can lead to symptom breakthrough 1
• Do not attempt dose titration - start directly at 400mg rather than using lower initial doses 1
• Do not rush cross-titration from other antipsychotics - allow >1 to 4 weeks for optimal tolerability 1
• Do not assume higher previous oral doses require higher depot doses - 400mg is appropriate regardless of prior oral dose 1