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.

Establishing Tolerability

Dosing

  • Available as prefilled syringes of the following doses:
    • Aristada 441 mg corresponds to a daily dose of oral aripiprazole 10 mg
    • Aristada 662 mg corresponds to a daily dose of oral aripiprazole 15 mg
    • Aristada 882 mg 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 corresponds to a daily dose of oral aripiprazole 15 mg

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.

Reference: VA Pharmacy Benefits Management Services. (2016). Aripiprazole long-acting-injection (Abilify Maintena, ARISTADA) [National Drug Monograph].   

  • Aristada 441 mg , 662 mg, and 1064 mg are approved for injection every 4 weeks
  • 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.
  • 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.
  • Refer to this tip for guidance on missed doses or treatment disruption.

Practical issues (including administration)

  • Aristada arrives in pre-filled syringes in the doses listed above.
  • 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.
  • 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.

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. 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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