Abilify Asimtufii

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

Abilify Asimtufii 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, restlessness, and other extrapyramidal symptoms. Other possible adverse effects include nausea, vomiting, constipation, dizziness, insomnia, anxiety, somnolence, and headache. Serious adverse reactions may 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 increase the risk of aspiration. Monitor weight, blood glucose, lipid levels, and abnormal involuntary movements as clinically appropriate. Abilify Asimtufii may cause drowsiness and impair judgment or motor skills. It is not approved for treating dementia-related psychosis in elderly patients. Patients who have never taken aripiprazole should establish tolerability with oral aripiprazole before starting treatment. The injection must be administered by a qualified healthcare professional.

The recommended dosage is 960 mg administered as a single intramuscular gluteal injection once every 2 months (56 days). The dose may be reduced to 720 mg once every 2 months if adverse reactions occur. For patients initiating treatment from oral antipsychotics, treatment may require either a one-day initiation regimen involving Abilify Asimtufii 960 mg, Abilify Maintena 400 mg, and oral aripiprazole 20 mg, or a 14-day initiation regimen with concurrent oral aripiprazole 10–20 mg daily or the current oral antipsychotic, according to the prescribing information. Patients switching from Abilify Maintena may receive Abilify Asimtufii in place of their next scheduled injection. Dosage adjustments may be necessary for known CYP2D6 poor metabolizers and patients taking interacting medications. Treatment must be prescribed and administered under specialist supervision.

Strong CYP2D6 inhibitors, such as fluoxetine and paroxetine, and strong CYP3A4 inhibitors, such as clarithromycin and itraconazole, may increase aripiprazole exposure and require dosage adjustment. Strong CYP3A4 inducers, such as carbamazepine and rifampin, may decrease aripiprazole exposure and reduce therapeutic effectiveness. Concomitant use with antihypertensive medications may increase the risk of hypotension. Alcohol and other central nervous system depressants may increase drowsiness 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 Asimtufii.