Aripiprazole monohydrate LAI

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What it isLong-acting dopamine partial agonist with serotonin-receptor activity; schizophrenia and maintenance of bipolar I disorder.

Why this oneUnlike aripiprazole lauroxil, it also carries a bipolar I maintenance indication.

What limits itInitiation needs two weeks of overlapping oral aripiprazole (or the two-injection start), and akathisia remains the characteristic complaint.

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	See initiation (1-day or 14-day)	400 mg IM monthly	—
Bipolar I disorder (maintenance monotherapy)	Adults	See initiation (1-day or 14-day)	400 mg IM monthly	—

Renal Undefined

Hepatic Undefined

400 mg monthly, no sooner than 26 days after the previous injection

Instructions

IM (deltoid or gluteal) by a healthcare professional
Establish tolerability with oral aripiprazole first
1-day initiation: two 400 mg injections + oral aripiprazole 20 mg; or 14-day: 400 mg + 14 days oral aripiprazole 10–20 mg
May reduce to 300 mg monthly for adverse reactions
CYP2D6 poor metabolizers: 300 mg monthly

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

Adverse reactions

Increased weight
Akathisia
Injection site pain
Sedation

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