What should clinicians know about Abilify Maintena (aripiprazole monohydrate LAI)?

Abilify Maintena (aripiprazole) is a long-acting injectable (LAI) formulation of aripiprazole. It is the first of two formulations of LAI aripiprazole (the other is Aristada [aripiprazole lauroxil]). It is FDA-indicated to treat adults with schizophrenia and bipolar disorder.

Establishing Tolerability

• Prior to initiating Abilify Maintena, establish tolerability with oral aripiprazole in aripiprazole-naïve patients.
• Due to its long half-life, establishing tolerability may require up to a two-week trial of oral aripiprazole.

Dosing

• Once every four-week intramuscular injection only, which must be administered by a healthcare provider.
• No loading dose strategy is available. Two weeks of oral overlap  (at therapeutic range) recommended at the time of administration of first injection. Oral aripiprazole (10-20 mg/d) or another antipsychotic must be continued for the first 14 days following the initial aripiprazole LAI.
• Recommended starting and maintenance dose is 400 mg (or lower dose of 300mg for patients who have had adverse reactions) administered once monthly (no sooner than 26 days after the previous injection). Provides maximum plasma concentration in 4–7 days, dependent on injection location, with deltoid injections achieving this sooner.
• Steady-state concentrations achieved by the 300- and 400-mg LAI formulations were within apparent therapeutic range observed with oral aripiprazole doses of 10 and 20 mg. Steady-state concentrations achieved with the 200-mg LAI formulation were found to be below the apparent therapeutic range observed with 10-mg oral daily dosing.
  • See this research article. 
• Refer to this tip on how to address missed doses.

Practical issues (including administration)

• Abilify Maintena comes in two forms:
  • Single dose prefilled dual chamber syringe kits for 300 mg and 400 mg doses – fewer steps and components. This formulation should be utilized within 30 minutes of reconstitution.
  • Single dose vial kit – more dosing flexibility to administer lower doses: 160 mg, 200 mg, 300 mg, or the standard (recommended starting and maintenance) dose of 400 mg.
• All doses and formulations of Abilify Maintena can be administered intramuscularly in the deltoid or gluteal muscle.

FDA Medication Label

Information on this topic is found in the FDA medication label. Prescribing should always be informed by the FDA medication label. Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices.

Labels change over time, and the current label should always be consulted. Here is the most recent label, at time of writing.

Administration/Dosing Guide

More information about administration (including a detailed video) and dosing can be found here.