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 |
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. |
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. |
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. | |
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.