Drug updated on 9/5/2024
Dosage Form | Injection (intramuscular; 300 mg and 400 mg) |
Drug Class | Long-acting injectable atypical antipsychotics |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of schizophrenia in adults.
- Indicated for maintenance monotherapy treatment of bipolar I disorder in adults.
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Summary
- Abilify Maintena (aripiprazole) is indicated for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.
- This summary is based on the review of seven systematic reviews/meta-analyses. [1-7]
- Schizophrenia and Schizoaffective Disorder: Long-acting injectable antipsychotics (LAIs) are generally effective in treating schizophrenia spectrum disorders (SSD), including schizophrenia and schizoaffective disorder. Limited studies suggest good effectiveness in adolescents with SSD (13 articles, 119 adolescents). Aripiprazole, risperidone, and paliperidone palmitate show effectiveness, particularly in early psychosis patients, though most data are from naturalistic studies rather than randomized controlled trials (RCTs).
- Bipolar I Disorder: Aripiprazole 400 mg IM once monthly is effective in preventing manic episodes in bipolar I disorder with minimal metabolic effects. Other atypical antipsychotics, such as quetiapine, cariprazine, and lurasidone, also demonstrate efficacy in treating different phases of bipolar disorder.
- Treatment Emergent Adverse Events (TEAEs): No significant difference in the risk of TEAEs was observed between LAIs and placebo, with a lower risk of serious TEAEs for LAIs compared to placebo, except for aripiprazole.
- Metabolic Side Effects: Aripiprazole LAI demonstrates minimal metabolic effects and no significant dose-response association with weight gain, unlike other antipsychotics such as lurasidone and olanzapine.
- Population Types and Subgroup Considerations: Limited evidence indicates that long-acting injectable antipsychotics (LAIs) are safe and effective in adolescents (aged 12-17) with schizophrenia spectrum disorders (SSD), with no studies available for children under 12 years. LAIs may also benefit early psychosis patients by improving adherence, reducing relapse, and enhancing symptom management. Aripiprazole LAI has been shown to be effective and well-tolerated in preventing manic episodes in youth with bipolar disorder.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Abilify Maintena (aripiprazole) Prescribing Information. | 2020 | Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan |