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

Aristada Initio (aripiprazole lauroxil) is a long-acting, one-time loading dose injectable (LAI) formulation of aripiprazole used to avoid the necessity of oral Abilify (aripiprazole). It is FDA-indicated to treat adults with schizophrenia when initiating Aristada (aripiprazole lauroxil).

Establishing Tolerability

• Establish tolerability with oral aripiprazole prior to initiating Aristada or Aristada Initio for patients who are aripiprazole naïve.

Dosing

• A 675 mg single dose (injection volume of 2.4 ml) is given to initiate (or re-initiate) Aristada with one oral dose of Abilify (aripiprazole). One Initio injection  and one 30mg oral dose of Abilify (aripiprazole) results in serum concentrations comparable to 21-days of oral aripiprazole.
  • Initiate treatment on day 1 with:
    • Aristada Initio injection PLUS
    • A single dose of 30mg oral aripiprazole PLUS
    • The first dose of Aristada (441, 662, 882, or 1064 mg). The first dose of Aristada can be given on same day as Initio or up to 10 days later.
  • A subsequent dose of Aristada will next be given either 4, 6, or 8 weeks later, depending on prescribed dose and frequency regimen. See the clinical tip on Aristada.
  • Aristada Initio cannot be used for maintenance treatment, only for one-time initiation

Practical issues (including administration)

• Aristada Initio is only to be administered as an IM injection by a healthcare provider.
  • It can be administered in deltoid or gluteal muscle.
  • Avoid injecting Aristada and Aristada Initio concomitantly in the same 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 and dosing can be found here.