Aripiprazole lauroxil LAI

ARISTADA INITIO

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What it isDopamine partial agonist with serotonin-receptor activity; initiation of aripiprazole lauroxil maintenance for schizophrenia.

Why this oneIt exists only as a bridge: one INITIO injection plus one oral dose replace prolonged oral overlap when starting ARISTADA.

What limits itIt is a one-time initiation or re-initiation tool — not for repeated dosing, and its single strength is not interchangeable with ARISTADA maintenance strengths.

FDA label

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BOXED WARNING Increased mortality in elderly patients with dementia-related psychosis treated with antipsychotics; not approved for dementia-related psychosis.

FDA dosing	Population	Start	Target	Max
Initiation of ARISTADA (schizophrenia), with oral aripiprazole	Adults	675 mg IM ×1 + oral aripiprazole 30 mg ×1	Single dose only (not for repeated dosing)	—

Renal No adjustment needed

Hepatic No adjustment needed

Single administration only; not for repeated dosing

Instructions

Single IM dose only (deltoid or gluteal); not interchangeable with ARISTADA
Establish tolerability with oral aripiprazole first
Avoid in known CYP2D6 poor metabolizers and with strong CYP3A4/CYP2D6 inhibitors or CYP3A4 inducers (no dose adjustment possible)

Cautions

Increased mortality in elderly with dementia-related psychosis (boxed) and cerebrovascular reactions/stroke
Neuroleptic malignant syndrome
Tardive dyskinesia
Metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain)
Pathological gambling and other compulsive behaviors
Orthostatic hypotension/syncope
Leukopenia, neutropenia, agranulocytosis
Seizures
Cognitive/motor impairment
Dosing/medication errors between ARISTADA INITIO and ARISTADA

Adverse reactions

Akathisia
Injection site pain
Increased weight
Increased blood creatine phosphokinase
Headache
Insomnia
Restlessness

Pregnancy Third-trimester exposure: risk of neonatal extrapyramidal/withdrawal symptoms; may decrease milk supply. Registry available.

Lactation Present in human breast milk; may cause clinically relevant decreases in milk supply; monitor infant for dehydration and poor weight gain.

⚠ BOXED WARNING