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 |
Drug Metabolizing Enzymes | CYP2D6, CYP3A4 |
Loading dose | One day, single-dose regimen of the following: |
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. |
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 |
Reconstitution 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. |
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. 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 and dosing can be found here.