Aripiprazole lauroxil LAI

ARISTADA

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What it isLong-acting injectable antipsychotic prodrug for schizophrenia; tissue hydrolysis slowly releases aripiprazole.

Why this oneInterval flexibility spans four-, six-, and eight-week dosing, fitting the schedule to the patient.

What limits itConversion is slow, so initiation requires three weeks of oral aripiprazole overlap or ARISTADA INITIO plus oral aripiprazole.

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
Schizophrenia	Adults	Initiate with ARISTADA INITIO 675 mg + oral aripiprazole 30 mg ×1, or 21 days oral aripiprazole	441, 662, or 882 mg IM monthly; 882 mg q6wk; or 1064 mg q2mo	—

Renal No adjustment needed

Hepatic No adjustment needed

Injection not earlier than 14 days after previous dose

Instructions

IM injection (deltoid or gluteal per dose) by a healthcare professional
Establish tolerability with oral aripiprazole before first injection
Do not give an injection earlier than 14 days after the previous one
CYP2D6 poor metabolizers and strong CYP3A4/CYP2D6 inhibitors or CYP3A4 inducers >2 wk: adjust dose (see Table 4)

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 and ARISTADA INITIO

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