- For patients without a history of aripiprazole use, establish tolerability for up to 2 weeks with oral aripiprazole prior to initiating therapy
- For patients already stable on oral aripiprazole or another oral antipsychotic, after the first ABILIFY MAINTENA injection, continue treatment with the antipsychotic for 14 consecutive days
*Oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic.
- ABILIFY MAINTENA is to be administered by either deep intramuscular deltoid or gluteal injection by a healthcare professional
- After the first injection of ABILIFY MAINTENA, treatment with oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic should be continued for 14 consecutive days
- If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg
- For additional dosage and administration information, please see FULL PRESCRIBING INFORMATION, including BOXED WARNING
Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.
Review the Initiation Guide before prescribing
This helpful resource has information to get your appropriate patients started on ABILIFY MAINTENA.
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 of administration.
- Rotate site of injection between the 2 deltoid or gluteal muscles
- Each box of ABILIFY MAINTENA offers needle options for deltoid and gluteal administration—
no additional ordering needed
- In an open-label study comparing bioavailability of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain was observed in both groups at approximately equal rates
In a short-term, clinical trial with ABILIFY MAINTENA in patients with schizophrenia treated with gluteal administered ABILIFY MAINTENA, the percent of patients reporting any injection site-related adverse reaction was 5.4%, and 0.6% for placebo. In an open label study of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain was observed at approximately equal rates.
- 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
Adjustments if the second or third doses are missed:
Adjustments if the fourth or subsequent doses are missed:
Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers for less than 14 days.
Adjustments based on CYP2D6 metabolism or concomitant medications
†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 INITIATION GUIDE.
Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with oral aripiprazole.
ABILIFY MAINTENA options offer flexibility in dosing and administration. It is available in a pre-filled, dual chamber syringe and vial kit.
Instruction for use videos
The following are instructional videos on how to use the 2 delivery systems.
Pre-filled, dual chamber syringe instructions for use
Vial kit instructions for use
Choices that offer flexibility in administration
Pre-filled, dual chamber syringe
- 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 ABILIFY MAINTENA, remember to specify either the pre-filled, dual chamber syringe or the vial kit.
- Along with the first injection, patients should also receive a prescription for oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic for 14 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.]