Dosing and administration options
ABILIFY MAINTENA ® (aripiprazole) options offer flexibility in dosing and administration. It is available in a pre-filled, dual chamber syringe and vial kit.
Instructions for Use Videos
The following are instructional videos on how to use the 2 delivery systems.

Dosing and Administration Guide
DOWNLOADInjection Site Reactions:
In a short-term, clinical trial with
Dosing and Administration
ABILIFY MAINTENA ® (aripiprazole) provides options for dosing and administration
ADMINISTRATION
- Two intramuscular (IM) administration sites: deltoid or gluteal
- Two delivery systems: pre-filled, dual chamber syringe or vial kit
- All doses can be given by deltoid or gluteal IM administration
- Only for administration by a healthcare professional
RECOMMENDED STARTING AND MAINTENANCE DOSE
-
For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with
ABILIFY MAINTENA . Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability - 400-mg single injection administered monthly
- Along with first injection of
ABILIFY MAINTENA , treatment with oral aripiprazole(10 mg to 20 mg) or current oral antipsychotic should be continued for14 consecutive days - Consider reducing to 300 mg in patients with adverse reactions
- Do not administer
ABILIFY MAINTENA any sooner than 26 days after previous injection
DOSAGE ADJUSTMENTS
- Dosage adjustments are required for missed doses
- Dosage adjustments are recommended for patients who are CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for more than 14 days
- Avoid concomitant use of CYP3A4 inducers with
ABILIFY MAINTENA for more than 14 days
For additional dosage and administration information, please see
FULL PRESCRIBING INFORMATION, including BOXED WARNING.
Important Warning and Precaution Regarding Pathological Gambling and Other Compulsive Behaviors:
Intense urges, particularly for gambling, and the inability to control these urges have been reported while taking aripiprazole. Other compulsive urges have been reported less frequently. Prescribers should ask patients or their caregivers about the development of new or intense compulsive urges. Consider dose reduction or stopping aripiprazole if such urges develop.
Choices that offer flexibility in administration

- Pre-filled, dual chamber syringe reduces the number of steps required for reconstitution compared with the vial kit
- Administer within 30 minutes after reconstituting
pre-filled, dual chamber syringe

- Vial kits provide the flexibility to choose doses in amounts other than 400 mg or 300 mg in patients requiring dosage adjustments
Specify the choice of delivery system
When writing an electronic or conventional prescription for

- Along with the first injection, patients should also receive a prescription for oral aripiprazole
(10 mg to 20 mg) or current oral antipsychotic for14 consecutive days - All doses can be given by gluteal or deltoid intramuscular administration. See above for dosing information
- Both the pre-filled, dual chamber syringe and the vials are stored at room temperature*
*Pre-filled, dual chamber syringe: Store below 30°C (86°F). Do not freeze. Protect the syringe from light by storing in the original package until time of use.
Vial: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
Important Warning and Precaution Regarding Orthostatic Hypotension:
Important Warning and Precaution Regarding Falls:
Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.
Pharmacokinetic Study
ABILIFY MAINTENA ® (aripiprazole) keeps blood concentrations of aripiprazole within therapeutic levels throughout the month in adult patients with schizophrenia.1,2
Mean plasma concentration from first gluteal injection to 24 weeks
*Patients received oral aripiprazole 10 mg/day for 14 days prior to the first
Cmin,ss=minimum steady-state plasma drug concentration during a dosage interval.1
Open-label Phase 1b study1:
- Assessed the safety, tolerability, effectiveness, and pharmacokinetics of
ABILIFY MAINTENA administered by gluteal intramuscular injection to patients with schizophrenia - Mean steady-state plasma concentration range for once-monthly
ABILIFY MAINTENA 400 mg (n=12) was within the concentration range for multiple, consecutive daily doses (14 days) of oral aripiprazole 10 mg to 30 mg1-3 - Following multiple doses, there is a gradual rise of aripiprazole to maximum plasma concentration (Tmax) at a median of 4 days for the deltoid muscle and 5 to 7 days for the gluteal muscle
Important Warning and Precaution Regarding Leukopenia, Neutropenia, and Agranulocytosis:
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.
References: 1. Mallikaarjun S, Kane JM, Bricmont P, et al. Pharmacokinetics, tolerability and safety of aripiprazole once-monthly in adult schizophrenia: an open-label, parallel-arm, multiple-dose study. Schizophr Res. 2013;150(1):281-288. 2. Mallikaarjun S, Salazar DE, Bramer SL. Pharmacokinetics, tolerability, and safety of aripiprazole following multiple oral dosing in normal healthy volunteers. J Clin Pharmacol. 2004;44(2):179-187. 3. Data on file. ABIMAI-046.