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.
- 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.
Dose Conversion of Oral Aripiprazole to Aripiprazole LAI
Recommended available dose formulations include 300 and 400 mg pre-filled vial kits (PI recommended maximum 400 mg).
Dose reduction may be necessary for CYP450 interactions of side effect intolerance.
1. VA Pharmacy Benefits Management Services. (2016). Aripiprazole long-acting-injection (Abilify Maintena, ARISTADA) [National Drug Monograph].
2. American Psychiatric Association. (2020). The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia. American Psychiatric Association Publishing. https://doi.org/10.1176/appi.books.9780890424841
Practical issues (including administration)
- Abilify Maintena comes in two forms:
- Single dose prefilled dual chamber syringe kits for 300 mg (injection volume of 1.5 ml) and 400 mg doses (injection volume of 2.0 ml) – 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 (injection volume of 0.8 ml), 200 mg (injection volume of 1 ml), 300 mg (injection volume of 1.5 ml), or the standard (recommended starting and maintenance) dose of 400 mg (injection volume of 2 ml).
- 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.
More information about administration (including a detailed video) and dosing can be found here.
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If you would like more information on this topic, or would like to provide any feedback, please send us a message using our consultation system. Be sure to let us know about which tip you are writing. We would love to hear from you, and the consultation system is free to use and confidential. Thank you!