What should clinicians know about Aristada (aripiprazole lauroxil LAI)?

Aristada is a long-acting injectable (LAI) formulation of aripiprazole. It is one of two available formulations of LAI aripiprazole. It is FDA-indicated to treat adults with schizophrenia. Aristada can be given initially with Aristada Initio; refer to this tip on Aristada Initio.

Aristada

Indication(s)

Schizophrenia

Dosing available as prefilled syringes

Aristada 441 mg (injection volume of 1.6 ml) corresponds to a daily dose of oral aripiprazole 10 mg
Aristada 662 mg (injection volume of 2.4 ml) corresponds to a daily dose of oral aripiprazole 15 mg
Aristada 882 mg (injection volume of 3.2 ml) corresponds to:a daily dose of oral aripiprazole 15 mg when given every 6 weeks
a daily dose of oral aripiprazole 20 mg when given every 4 weeks
Aristada 1064 mg (injection volume of 3.9 ml) corresponds to a daily dose of oral aripiprazole 15 mg

Recommended starting and maintenance dose

May give 1st dose within 10 days  of concurrent Aristada Initio and Aripiprazole 30mg PO x1. Otherwise overlap PO Aripiprazole x21 days. See oral to LAI conversion for dosing equivalent.

Drug Metabolizing Enzymes

CYP2D6, CYP3A4 

Loading dose

Aristada Initio provides a loading dose strategy. Initio comes in one strength, 675 mg, in a pre-filled syringe, which a healthcare professional administers as an intramuscular injection on the day of or up to ten days prior to starting Aristada. Together with the Initio and Aristada, the patient takes one dose of oral aripiprazole 30 mg.
If the loading dose strategy is not used, two weeks of oral supplementation with aripiprazole is recommended.

Oral overlap

Oral aripiprazle should be given after the first injection for 21 consecutive days if Aristada Initio is not utilized

Establishing tolerability

Prior to initiating Aristada, establish tolerability with oral aripiprazole in aripiprazole-naïve patients.
Due to its long half-life, establishing tolerability requires at least a two-week trial of oral aripiprazole.

Storage

Room temperature; Store boxes flat to avoid clogging of syrringe 

Reconstitution or mixing

Due to the non-Newtonian properties and crystalline structure of Aristada, needle clogs can occur. Most importantly, Aristada needs to be 1) stored horizontally; 2) tapped firmly against the hand 10 times; 3) shaken vigorously for 30 seconds; and 4) injected rapidly.

Injection site

Aristada 441 mg and Aristada Initio can be administered in the deltoid or gluteal muscle. All other strengths of Aristada must be administered in the gluteal muscle.

Injection interval

Aristada 441 mg, 662 mg, and 882 mg are approved for injection every 4 weeks, 882 mg is approved for every 6 weeks, and 1064 mg is approved for every two months.

Preparation

Tap the syringe at least 10 times to dislodge any material which may have settled. Shake the syringe vigorously for at least 30 seconds. Priming of syringe is recommended.

Administration considerations

Patients who are stable on oral aripiprazole doses lower than 10 mg/day or higher than 20 mg/day may not be candidates for Aristada.

When a dose is missed

REMS

No

Dose Conversion of Oral Aripiprazole to Aripiprazole LAI

PO Dose

LAI/IM Dose

10 mg aripiprazole 

441 mg Aristada every 4 weeks

15 mg aripiprazole

662 mg Aristada every 4 weeks

15 mg aripiprazole

882 mg Aristada every 6 weeks

15 mg aripiprazole

1064 mg Aristada every 8 weeks

20 mg aripiprazole

882 mg Aristada every 4 weeks

Recommended available dose formulations include 441, 662, 882, and 1064 pre-filled vial kits.

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. 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.

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!
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