What are the dosing recommendations for long-acting versions of Abilify (aripiprazole)?

Dosing Recommendations for Long-Acting Versions of Abilify (Aripiprazole)

Long-Acting Injectable Aripiprazole Formulations

For patients with schizophrenia or bipolar disorder requiring maintenance treatment, aripiprazole long-acting injectable (LAI) formulations should be initiated at 400 mg as the standard starting and maintenance dose, administered once monthly. 1

Available Formulations:

1. Aripiprazole Monohydrate (Abilify Maintena®)

   • Standard dose: 400 mg IM once monthly
   • Administration site: Gluteal or deltoid muscle
   • Requires 14-day oral antipsychotic overlap when initiating

2. Aripiprazole Lauroxil (Aristada®)

   • Available in multiple dosing options:
     • 441 mg monthly
     • 662 mg monthly
     • 882 mg monthly or every 6 weeks
     • 1064 mg every 2 months

Initiation Protocol for Aripiprazole Monohydrate (Abilify Maintena®)

1. First Dose:

   • Administer 400 mg IM injection
   • Continue oral aripiprazole 10-20 mg/day (or previous antipsychotic) for 14 days 1

2. Subsequent Doses:

   • Continue with 400 mg IM injection once monthly
   • Administer within 7 days before or after the monthly due date

3. Missed Doses Management:

   • If second or third dose is missed and >4 weeks since last injection:
     • Resume 400 mg injection with 14-day oral antipsychotic supplementation
   • If fourth or subsequent dose is missed:
     • <6 weeks since last injection: Administer next injection as soon as possible

     • 6 weeks since last injection: Restart with 14-day oral supplementation

Special Population Considerations

1. Dose Adjustments:

   • Hepatic Impairment:

     • Moderate to severe impairment (Child-Pugh B or C): Reduce dose to 300 mg

   • Renal Impairment:

     • Severe impairment: Reduce dose to 300 mg

   • CYP2D6 Poor Metabolizers:

     • Reduce dose to 300 mg

2. Known CYP2D6 Poor Metabolizers or Patients Taking CYP3A4 Inhibitors or CYP2D6 Inhibitors:

   • Reduce dose to 300 mg

3. Patients Taking CYP3A4 Inducers:

   • Avoid concomitant use

Clinical Pearls and Pitfalls

• Pharmacokinetics: Aripiprazole LAI reaches therapeutic plasma concentrations within 7 days of administration but requires 14 days of oral antipsychotic overlap to ensure therapeutic levels 1

• Efficacy: In clinical trials, 90.1% of patients who initiated aripiprazole LAI 400 mg required no dose adjustments 1

• Tolerability: When switching from other oral antipsychotics to aripiprazole LAI, a cross-titration period of >1 to 4 weeks is better tolerated than ≤1 week, with lower discontinuation rates due to adverse events (2.7% vs 10.4%) 1

• Common Adverse Effects: Akathisia is the most common adverse event, affecting approximately 23% of patients 2

• Monitoring: Regular assessment for extrapyramidal symptoms, weight gain, and metabolic parameters is recommended, though aripiprazole has a more favorable metabolic profile compared to some other atypical antipsychotics 3

• Advantage: LAI formulations help address medication adherence issues, which affect 20-60% of patients with bipolar disorder 2

Evidence Quality

The recommendations are based on pharmacokinetic studies, clinical trials, and naturalistic studies that demonstrate the efficacy and safety of aripiprazole LAI formulations. In maintenance treatment studies, nearly twice as many LAI-treated participants remained stable compared to those treated with placebo over a 52-week period 2.