Generic Name and Formulations:
Aripiprazole lauroxil extended-release injectable suspension 441mg/1.6mL, 662mg/2.4mL, 882mg/3.2mL, 1064mg/3.9mL; for IM inj.
Indications for ARISTADA:
Treatment-naive: establish tolerability with oral aripiprazole first. Give by IM inj into the deltoid (441mg dose only) or gluteal muscle (all doses). Initial and maintenance: 441mg, 662mg, or 882mg once monthly (no sooner than 14 days after the previous inj), or 882mg once every 6 weeks, or 1064mg every 2 months. In conjunction with first injection, administer oral aripiprazole for 21 consecutive days. Dose adjustments for missed dose, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.
<18yrs: not established.
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Reevaluate periodically. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.
Potentiate antihypertensives; monitor BP and adjust dose. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine); reduce Aristada dose if concomitant use >14 days. Concomitant strong CYP3A4 inducers (eg, carbamazepine, rifampin); consider increasing Aristada dose if concomitant use >14 days. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).
Akathisia, headache, anxiety, insomnia, inj site pain, restlessness, orthostatic hypotension, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others.
For women exposed to Aristada during pregnancy, contact the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.
Kit—1 (prefilled syringe + safety needles)