Some information presented within this Center of Excellence was created in collaboration with the California Department of State Hospitals (DSH). This includes that the content has been specifically aligned to the DSH’s medication guidelines (DSH Psychotropic Medication Operational Procedures, appended to DSH Policy Directive 3400). These medication guidelines are applicable only to the DSH settings and inclusion within this resource does not indicate that they must be followed in any non-DSH settings. The medication guidelines included in this resource are those of DSH and do not necessarily represent the views, policy(ies), and/or position(s) of the American Psychiatric Association (APA).
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. |
Drug Metabolizing Enzymes | CYP2D6, CYP3A4 |
Loading dose | On day 1 give Abilify Maintena 300 mg or 400 mg IM. On day 7 give Abilify Maintena 300 mg or 400 mg IM. Maintenance dosing starts 4 weeks after second loading dose. |
Maintenance dose | Abilify Maintena 300 mg or 400 mg every 4 weeks. |
Oral overlap | Two weeks of oral overlap (at therapeutic range) recommended at the time of administration of first injection unless using loading doses. |
Establishing tolerability and efficacy | Prior to initiating Abilify Maintena, establish tolerability with oral aripiprazole in aripiprazole-naïve patients. Due to its long half-life, establishing tolerability and efficacy may require up to an 8-12 week trial of oral aripiprazole. |
Storage | Room temperature |
Reconstitution 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 a maintenance Abilify Maintena dose is missed, the next maintenance should be administered not later than 6 weeks after the last injection. If > 6 weeks, then reload. |
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 | |
Oral Dose | LAI/IM Dose |
Aripiprazole 15 mg | Abilify Maintena 300 mg |
Aripiprazole 20 mg | Abilify Maintena 400 mg |
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 or 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 3. California Department of State Hospitals Psychotropic Medication Operational Procedures | |
For more information, download this fact sheet developed by the DSH Psychopharmacology Resource Network (PRN).
FDA Medication Label
Information on this topic is found in the FDA medication label Not all information in the FDA medication label is included here, and clinicians should read the entire FDA medication label before making treatment decisions.
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 at time of writing. Here is the most recent label, at time of writing.
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Administration/Dosing Guide
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!