Welcome to the latest edition of our Guidelines+ Monographs Series. In this installment, we will delve into the medication aripiprazole, marketed under the brand name Abilify Asimtufii by Otsuka Pharmaceutical Co., Ltd. Abilify Asimtufii (aripiprazole) is a long-acting injectable atypical antipsychotic for the treatment of schizophrenia and bipolar I disorder. It was initially approved in 2023.
In the following sections, we will provide a comprehensive overview of aripiprazole and analyze its positioning across various guidelines for its approved indications.
Note* – This Guidelines+ Monographs for aripiprazole (Abilify Asimtufii) is current as of October 2024. Consult our clinical guidelines library and/or or medication information lookup tool to ensure you are always accessing the most current information.
Medication Overview:
- Brand name: Abilify Asimtufii®
- Generic name: aripiprazole
- Manufacturer(s): Otsuka Pharmaceutical Co., Ltd
- Initial FDA Approval: April 2023
Indications and FDA Approval Details
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| Schizophrenia | For the treatment of schizophrenia. | Adult | April 2023 |
| Bipolar I Disorder | As maintenance monotherapy treatment of bipolar I disorder | Adult | April 2023 |
Dosage and Strengths
Extended-release injectable suspension: 960 mg/3.2 mL and 720 mg/2.4 mL single-dose pre-filled syringes.
Boxed Warning
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death
- Abilify Asimtufii is not approved for the treatment of patients with dementia-related psychosis
Warnings and Precautions
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities)
- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
- Tardive Dyskinesia: Discontinue if clinically appropriate
- Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain
- Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation
- Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and caution in patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope
- Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with history of clinically significant low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing Abilify Asimtufii if clinically significant decline in WBC in the absence of other causative factors
- Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
- Potential for Cognitive and Motor Impairment: Use caution when operating machinery
Adverse Reactions
Most commonly observed adverse reactions (incidence ≥5% and at least twice the rate of placebo) were increased weight, akathisia, injection site pain, and sedation.
Now that we’ve covered the basic monograph information for aripiprazole, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Aripiprazole in Clinical Guidelines
- Management of First-Episode Psychosis and Schizophrenia (SCZ)
- Authoring Societies: Veteran Health Administration/Department of Defense (VA/DoD)
- Publication: May 10, 2023
- VA/DoD recommend using metformin, topiramate, or aripiprazole augmentation for treatment of metabolic side effects of antipsychotic medication and weight loss for individuals with schizophrenia.
- Management of Bipolar Disorder
- Authoring Society: VA/DoD
- Publication: September 30, 2023
- If lithium, quetiapine, olanzapine, paliperidone, or risperidone is not selected based on patient preference and characteristics, we suggest aripiprazole, asenapine, carbamazepine, cariprazine, haloperidol, valproate, or ziprasidone as monotherapy for acute mania.
- The VA/DoD suggest against the addition of aripiprazole, paliperidone, or ziprasidone after unsatisfactory response to lithium or valproate monotherapy for acute mania.
- The VA/DoD suggest aripiprazole, olanzapine, quetiapine, or ziprasidone in combination with lithium or valproate for the prevention of recurrence of mania.
- Treatment of Patients With Schizophrenia
- Authoring Society: American Psychiatric Association (APA)
- Publication: August 31, 2020
- APA recommends that patients with schizophrenia be treated with an antipsychotic medication and monitored for effectiveness and side effects.
- APA recommends that patients with schizophrenia whose symptoms have improved with an antipsychotic medication continue to be treated with an antipsychotic medication.
- APA suggests that patients with schizophrenia whose symptoms have improved with an antipsychotic medication continue to be treated with the same antipsychotic medication.
This concludes our Guidelines+ Monographs for Abilify Asimtufii (aripiprazole). This list is current as of October 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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