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).

Aristada Initio

Indication(s)

For the initiation of Aristada when used for the treatment of schizophrenia

Dosing available as prefilled syringes

675 mg (2.4 mL)

Recommended starting and maintenance dose

Aristada Initio cannot be used for maintenance treatment, only for one-time initiation of Aristada

Loading dose

One day, single-dose regimen of the following:
Administer one time: 30 mg oral aripiprazole PLUS
Administer one time: Aristada Initio IM 675 mg injection PLUS
Administer Aristada IM (441, 662, 882, 1064 mg) injection (may administer same day or up to 10 days after dose of Aristada Initio is administered)

Oral overlap

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.

Establishing tolerability

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

Storage

Room temperature; Store boxes flat to avoid clogging of syrringe 

Reconsititution or mixing

Tap the syringe on your hand at least 10 times. After tapping, shake the syringe vigorously for at least 10 seconds, until the medication is uniform. Priming of syringe is recommended.

Injection site

Gluteal or deltoid intramuscularly. Avoid injecting concomitantly in the same muscle as Aristada injection. 

Injection interval

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.

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.  Inject in a rapid and continuous manner.

Administration considerations

Product requires a rapid injection.  Do not hesitate.

REMS

No

Additional information

Aristada Initio cannot be used for maintenance treatment, only for one-time initiation

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.

 

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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