ABILIFY MAINTENA® (aripiprazole) IN PATIENTS TAKING ANY ORAL ANTIPSYCHOTIC
Establish tolerability with oral aripiprazole before initiating therapy. For patients already stable on oral aripiprazole or another oral antipsychotic, after the first
Initiation and Dosing
ABILIFY MAINTENA is a once-monthly LAI you can initiate from any oral antipsychotic
Recommended starting and maintenance dose of
ABILIFY MAINTENA is 400 mg once monthly1
*Oral aripiprazole (
Important Warning and Precaution Regarding Concomitant Medication
Dosage adjustments are recommended in patients who are CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days. Avoid concomitant use of CYP3A4 inducers with ABILIFY MAINTENA for greater than 14 days. Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days.
All doses can be given by deltoid or gluteal intramuscular administration
400 mg and 300 mg doses may be given via the deltoid and gluteal injection sites
Needle options are conveniently color-coded based on the size of patient and site
- Rotate site of injection between the 2 deltoid or gluteal muscles
- Each box of
ABILIFY MAINTENAoffers needle options for deltoid and gluteal administration—no additional ordering needed
Important Warning and Precaution Regarding Injection Site Reactions
Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers for less than 14 days.
†200 mg and 160 mg dosage adjustments are obtained only by using the 300 mg or 400 mg strength vial kits.
For additional dosage and administration information, please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.
TO LEARN MORE ABOUT DOSE ADJUSTMENTS, DOWNLOAD THE
Important Warning and Precaution Regarding Orthostatic Hypotension
ABILIFY MAINTENA may cause orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.
In patients with schizophrenia, doses of
ABILIFY MAINTENA provided a range of aripiprazole levels consistent with oral aripiprazole2
Median aripiprazole average steady-state‡ plasma concentrations (Cavg,ss) for daily oral aripiprazole and once-monthly
Simulations based on pharmacokinetic data in patients with schizophrenia
‡Steady-state concentrations for the typical subject were attained by the fourth dose for both gluteal and deltoid sites of administration.
§Data from the gluteal site.
After achieving steady state, adults with schizophrenia reached maximum plasma concentrations of aripiprazole within 1 week2
Mean plasma concentration from ﬁrst gluteal injection to 24 weeks in a Phase Ib, open-label pharmacokinetic study2
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.
Instructions for Use
ABILIFY MAINTENA options offer flexibility in dosing and administration. It is available in a pre-filled, dual chamber syringe and vial kit.
Instructions for Use Videos
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
- 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 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. Kane JM, Sanchez R, Perry PP, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73(5):617-624. 2. 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.