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ARISTADA INITIO
Psychosis
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Drug Name:

ARISTADA INITIO Rx

Generic Name and Formulations:
Aripiprazole lauroxil extended-release injectable suspension 675mg/2.4mL; for IM inj.

Company:
Alkermes

Therapeutic Use:

Indications for ARISTADA INITIO:

In combination with oral aripiprazole, for initiation (or reinitiation after a missed dose) of Aristada when used to treat schizophrenia.

Adult:

Not interchangeable with Aristada. Treatment-naive: establish tolerability with oral aripiprazole first. Give 675mg as IM inj into the deltoid or gluteal muscle in conjunction with oral aripiprazole 30mg as a single dose. Administer first Aristada inj on same day as Aristada Initio or ≤10 days after; avoid inj into same muscle. Missed doses or treatment reinitiation: see full labeling. CYP2D6 poor metabolizers, concomitant strong CYP2D6 inhibitors, or strong CYP3A4 inhibitors/inducers: avoid. Refer to Aristada monograph for dosing.

Children:

Not established.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis.

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.

See Also:

ARISTADA

Pharmacological Class:

Atypical antipsychotic.

Interactions:

Concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine); reduce Aristada dose if concomitant use >14 days; avoid with Aristada Initio. Concomitant strong CYP3A4 inducers (eg, carbamazepine, rifampin); consider increasing Aristada dose if concomitant use >14 days; avoid with Aristada Initio. Potentiate antihypertensives (eg, carvedilol, lisinopril, prazosin), benzodiazepines (eg, lorazepam); monitor BP and adjust dose; avoid with Aristada Initio. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

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 Initio 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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