ABILIFY MAINTENA: Monthly Injectable Treatment for Schizophrenia and Bipolar I Disorder in Adults

ABILIFY MAINTENA is an extended-release injectable suspension of aripiprazole, administered by intramuscular injection once monthly. It is used specifically for the treatment of schizophrenia and maintenance monotherapy in bipolar I disorder in adults. The medication is designed for gradual delivery to maintain therapeutic levels over time.

ABILIFY MAINTENA is approved for the following uses in adults:

• Treatment of schizophrenia.
• Maintenance monotherapy treatment of bipolar I disorder.

It is not approved for treating patients with dementia-related psychosis.

aripiprazole

Aripiprazole, the active ingredient in ABILIFY MAINTENA, acts as an atypical antipsychotic. It modulates neurotransmitter activity in the brain, particularly dopamine and serotonin receptors, to help stabilize mood and manage symptoms associated with schizophrenia and bipolar I disorder.

General Administration

• Administered monthly by deep intramuscular injection into the deltoid or gluteal muscle by a healthcare professional only.
• Do not use other administration routes.

Initial Treatment

• Patients must first tolerate oral aripiprazole before starting ABILIFY MAINTENA (due to its long half-life, tolerability assessment may take up to 2 weeks).
• There are two initiation options for patients previously on oral antipsychotics:

1. 1-day initiation: Two separate IM injections of 400 mg each (into different muscles, either deltoid or gluteal) plus a single oral dose of 20 mg aripiprazole on the first treatment day.
2. 14-day initiation: One 400 mg IM injection plus 14 consecutive days of oral aripiprazole (10-20 mg) or current oral antipsychotic to maintain therapeutic levels.

Maintenance Dose

• Recommended dose: 400 mg once monthly, no sooner than 26 days after the last injection.
• If adverse reactions occur, dose may be reduced to 300 mg monthly.

Missed Doses

• If 2nd or 3rd dose missed and 4-5 weeks have passed since last injection, inject as soon as possible.
• If more than 5 weeks since last injection, restart treatment using the 1-day or 14-day initiation regimen.
• If 4th or later doses missed and 4-6 weeks have passed since last injection, inject as soon as possible.
• If more than 6 weeks since last injection, restart treatment with initiation regimen.

Dose Adjustments for Cytochrome P450 Interactions

• Known CYP2D6 poor metabolizers: recommended dose is 300 mg monthly.
• Avoid use with strong CYP3A4 inhibitors in poor metabolizers.
• When strong CYP2D6 or CYP3A4 inhibitors are co-administered for over 14 days, reduce dose as specified (see detailed tables in full prescribing information).
• Avoid concomitant use of CYP3A4 inducers for more than 14 days.

No explicit contraindications stated in provided evidence.

Boxed Warning

Elderly patients with dementia-related psychosis treated with antipsychotics, including ABILIFY MAINTENA, have an increased risk of death. ABILIFY MAINTENA is not approved for treating dementia-related psychosis.

Drug Interactions

• CYP2D6 Poor Metabolizers: Recommended dose adjustment to 300 mg monthly; avoid concomitant strong CYP3A4 inhibitors.
• Strong CYP2D6 or CYP3A4 Inhibitors: Dose may require reduction when used for longer than 14 days; specific dose modifications depend on whether 1-day or 14-day initiation is used.
• CYP3A4 Inducers: Avoid concomitant use for longer than 14 days due to potential reduction in aripiprazole blood levels.
• No dose adjustment recommended if CYP inhibitors or inducers are used for less than 14 days.

Store ABILIFY MAINTENA components and kits at room temperature. Follow specific instructions for reconstitution and administration immediately after preparation. Do not store suspension after reconstitution in a syringe.