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.

Abilify Maintena

Indication(s)

Schizophrenia

Dosing available as prefilled syringes

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).

Recommended starting and maintenance dose

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.

Loading dose

Not established

Oral overlap

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.

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.

Storage

Room temperature

Reconsititution or mixing

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.

Injection site

Intramuscularly in the deltoid or gluteal muscle

Injection interval

Every 4 weeks

Preparation

Lyophilized powder in vial: requires reconstitution with provided sterile water for injection; vial requires vigorous shaking for 30 seconds after insertion of sterile water

Administration considerations

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

When a dose is missed

Abilify Maintena doses should be administered not earlier than 26 days after the last injection.
If the second or third doses are missed, Abilify Maintena should be administered not later than 5 weeks after the last injection.
If the fourth or subsequent doses are missed, Abilify Maintena should be administered not later than 6 weeks after the last injection.

More information

REMS

No

Additional information

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.

Dose Conversion of Oral Aripiprazole to Aripiprazole LAI

PO Dose

LAI/IM Dose

15 mg aripiprazole

300 mg Abilify Maintena

20 mg aripiprazole

400 mg Abilify Maintena

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.

References:
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

 

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.
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: www.smiadviser.org/submit-consult. 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!

 

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!

  • Was this Helpful ?
  • YesNo

Join our #MissionForBetter now

Sign up for our newsletter. We’ll let you know about new resources, education, and more.

X