Abilify Maintena

Abilify Maintena is indicated for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.

Abilify Maintena is contraindicated in patients with known hypersensitivity to aripiprazole or any component of the formulation. Hypersensitivity reactions may include anaphylaxis, pruritus, and urticaria.

Common adverse reactions include weight gain, injection-site pain, akathisia, sedation, and extrapyramidal symptoms. Other adverse effects may include insomnia, anxiety, headache, nausea, vomiting, constipation, dizziness, and restlessness. Serious adverse reactions include neuroleptic malignant syndrome, tardive dyskinesia, orthostatic hypotension, seizures, metabolic abnormalities, compulsive behaviors, and severe allergic reactions. Elderly patients with dementia-related psychosis have an increased risk of death when treated with antipsychotic medications.

Monitor patients for neuroleptic malignant syndrome, tardive dyskinesia, orthostatic hypotension, metabolic changes, and compulsive behaviors. Use caution in patients with cardiovascular disease, diabetes mellitus, a history of seizures, or conditions that predispose them to hypotension. Monitor body weight, blood glucose, lipid levels, and abnormal involuntary movements as clinically appropriate. Abilify Maintena may cause drowsiness and impair judgment or motor skills. Patients who have never taken aripiprazole should establish oral tolerability before starting treatment. The injection must be administered by a qualified healthcare professional. This medication is not approved for treating dementia-related psychosis in elderly patients.

The recommended dosage for schizophrenia and maintenance monotherapy of bipolar I disorder in adults is 400 mg administered by intramuscular injection once monthly, with doses at least 26 days apart. The dose may be reduced to 300 mg monthly if adverse reactions occur. Treatment initiation generally requires either a 14-day initiation regimen with oral aripiprazole 10–20 mg daily or the current oral antipsychotic, or a one-day initiation regimen involving two separate 400 mg injections at different injection sites plus a single 20 mg oral dose of aripiprazole, according to the prescribing information. Dosage adjustments may be necessary for CYP2D6 poor metabolizers and patients taking CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers. Administer only by the approved intramuscular route, following the product-specific preparation and administration instructions.

Strong CYP2D6 inhibitors, such as fluoxetine and paroxetine, and strong CYP3A4 inhibitors, such as itraconazole and clarithromycin, may increase aripiprazole exposure and require dosage adjustment. Strong CYP3A4 inducers, such as carbamazepine and rifampin, may decrease aripiprazole exposure and reduce therapeutic effectiveness; prolonged concomitant use should generally be avoided according to the prescribing information. Concomitant use with antihypertensive medications may increase the risk of hypotension. Alcohol and other central nervous system depressants may increase sedation and impairment. Review all prescription medicines, over-the-counter products, and supplements before treatment.

DailyMed, US National Library of Medicine; US Food and Drug Administration (FDA); Otsuka America Pharmaceutical, Inc., official prescribing information for Abilify Maintena.