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. |
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 | 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 |
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. |
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). | |
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. 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.
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