What is the proper administration and dosage of Abilify (aripiprazole) film for an adult or adolescent patient with a psychiatric condition, such as schizophrenia or bipolar disorder?

Abilify (Aripiprazole) Administration and Dosing

Adult Dosing for Schizophrenia

The recommended starting and target dose for aripiprazole is 10 or 15 mg once daily, administered without regard to meals, with no dosage titration required. 1

• Aripiprazole has been systematically evaluated and shown effective in a dose range of 10 to 30 mg/day 1
• Doses higher than 10 or 15 mg/day were not more effective than the lower doses 1
• Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state 1
• The drug demonstrates rapid onset of action within the first week of treatment 2, 3

Adolescent Dosing for Schizophrenia (Ages 13-17)

The recommended target dose for adolescents is 10 mg/day, with a specific titration schedule starting at 2 mg daily. 1

• Start with 2 mg daily, titrate to 5 mg after 2 days, then to target dose of 10 mg after 2 additional days 1
• Subsequent dose increases should be administered in 5 mg increments 1
• The 30 mg/day dose was not shown to be more efficacious than 10 mg/day in adolescents 1
• Aripiprazole can be administered without regard to meals 1

Bipolar I Disorder - Manic Episodes

For adolescents aged ≥13 years with moderate to severe manic episodes, oral aripiprazole 10 mg once daily for 12 weeks is the approved regimen in the EU. 4

• Aripiprazole is effective in reducing symptoms of mania in adolescents with bipolar I disorder 4
• Tolerability is less favorable in younger patients (10-12 years) compared to older subjects (≥13 years) 4
• The drug is associated with sedation, weight gain, and extrapyramidal symptoms, though EPS incidence at 10 mg/day was not significantly different from placebo over 12 weeks 4

Dosage Adjustments for Drug Interactions

Dosage adjustments are mandatory when aripiprazole is coadministered with CYP2D6 or CYP3A4 inhibitors/inducers. 1

• With strong CYP2D6 or CYP3A4 inhibitors: Administer half of usual dose 1
• With both strong CYP2D6 and CYP3A4 inhibitors: Administer one-quarter of usual dose 1
• With strong CYP3A4 inducers (e.g., carbamazepine, rifampin): Double usual dose over 1 to 2 weeks 1
• Known CYP2D6 poor metabolizers: Administer half of usual dose 1
• When the coadministered drug is withdrawn, adjust aripiprazole back to original level 1

Oral Solution Administration

The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. 1

• Patients receiving 30 mg tablets should receive 25 mg of the solution 1

Maintenance Treatment

Patients should be periodically reassessed to determine the continued need for maintenance treatment, as aripiprazole maintains efficacy for up to 52 weeks. 1, 3

• Maintenance efficacy in schizophrenia was demonstrated in trials with patients who had been symptomatically stable on other antipsychotics for ≥3 months 1
• Aripiprazole was significantly more effective than placebo in preventing relapse in patients with stable chronic schizophrenia 3
• The percentage of responders maintaining response at 52 weeks was 77% with aripiprazole 3

Switching from Other Antipsychotics

While immediate discontinuation of the previous antipsychotic may be acceptable for some patients, more gradual discontinuation is appropriate for others, with the period of overlapping antipsychotic administration minimized. 1

Common Pitfalls to Avoid

• Do not increase dosage before 2 weeks: Steady-state is not achieved until 14 days due to the 75-hour elimination half-life 1, 3
• Do not exceed 15 mg/day in most patients: Higher doses (20-30 mg/day) provide no additional therapeutic benefit 1, 3
• Do not forget CYP450 adjustments: Failure to adjust dose with interacting medications can lead to toxicity or treatment failure 1
• Monitor for weight gain in adolescents: Tolerability is less favorable with higher dosages (30 mg/day) compared to 10 mg/day 4