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ARISTADA
Psychosis
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Drug Name:

ARISTADA Rx

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.

Company:
Alkermes

Therapeutic Use:

Indications for ARISTADA:

Schizophrenia.

Adult:

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.

Children:

<18yrs: not established.

Warnings/Precautions:

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.

Interactions:

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).

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Akathisia, headache, anxiety, insomnia, inj site pain, restlessness, orthostatic hypotension, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others.

Note:

For women exposed to Aristada during pregnancy, contact the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Availability:

NO

How Supplied:

Kit—1 (prefilled syringe + safety needles)

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