How to initiate Maintena (aripiprazole) treatment?

How to Initiate Aripiprazole Maintena Treatment

The recommended approach for initiating Aripiprazole Maintena (aripiprazole once-monthly) is to administer a 400 mg intramuscular injection along with 14 days of oral aripiprazole (10-20 mg daily) to ensure therapeutic plasma concentrations are reached.

Initial Dosing Protocol

• First Injection:

  • Administer 400 mg of Aripiprazole Maintena as an intramuscular injection in the gluteal muscle
  • This is both the starting and maintenance dose based on pharmacokinetic data 1

• Oral Supplementation:

  • Provide 14 days of oral aripiprazole (10-20 mg daily) concurrently with the first injection
  • This overlap ensures therapeutic concentrations while the long-acting formulation reaches steady state 1

Alternative Two-Injection Start Option

For patients where adherence to 14 days of oral medication may be challenging:

• Same-Day Two-Injection Protocol:
  • Two separate 400 mg injections administered on the same day at different injection sites (gluteal and/or deltoid)
  • Single 20 mg oral aripiprazole dose on day 1 only
  • This approach provides comparable pharmacokinetic profile to the standard initiation regimen 2
  • Clinical data supports similar safety and tolerability to the standard approach 3

Pre-Initiation Considerations

1. Prior Antipsychotic Treatment:

   • If patient is not currently on aripiprazole, cross-titrate from current antipsychotic to oral aripiprazole over >1-4 weeks before initiating Maintena
   • Cross-titration periods >1 week show lower discontinuation rates due to adverse events (2.7%) compared to rapid switching (≤1 week, 10.4%) 1

2. Target Oral Aripiprazole Dose:

   • Stabilize on oral aripiprazole 10-30 mg daily before initiating Maintena
   • Efficacy and safety of Maintena 400 mg are comparable regardless of whether patients were previously on 10 mg or 30 mg oral aripiprazole 1

Monitoring After Initiation

• Assess therapeutic response after 4 weeks
• Monitor for common side effects:
  • Movement disorders (akathisia, extrapyramidal symptoms)
  • Gastrointestinal disturbances (nausea, constipation)
  • Metabolic effects (weight gain, glucose changes)

Special Considerations

• CYP2D6 Poor Metabolizers: Reduce dose to 300 mg
• Patients on CYP3A4 or CYP2D6 Inhibitors: Reduce dose to 300 mg
• Patients on Strong CYP3A4 Inducers: May require dose adjustment

Clinical Pearls

• Therapeutic aripiprazole plasma concentrations are typically reached within 7 days of initiating Maintena 400 mg, but the 14-day oral overlap ensures consistent coverage 1
• In clinical studies, 90.1% of patients who initiated Maintena 400 mg required no dose adjustments 1
• The 400 mg starting dose has shown to be both efficacious and well-tolerated across multiple studies 1, 4

This approach ensures optimal therapeutic coverage while minimizing the risk of relapse during the transition to long-acting injectable therapy.