Aripiprazole monohydrate LAI

ABILIFY ASIMTUFII

Open Aripiprazole monohydrate LAI in the interactive console ↗

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

Why this oneFor patients stable on monthly aripiprazole it halves the injection visits — one gluteal injection covering two months.

What limits itIt is a continuation product: tolerability is established on oral or monthly aripiprazole first, and it is given gluteally only.

FDA label

Read the full label on DailyMed ↗

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)	960 mg IM q2mo	—
Bipolar I disorder (maintenance monotherapy)	Adults	See initiation (1-day or 14-day)	960 mg IM q2mo	—

Renal Undefined

Hepatic Undefined

960 mg once every 2 months (56 days after previous injection); window ±2 weeks

Instructions

Gluteal IM only, by a healthcare professional
Establish tolerability with oral aripiprazole first
1-day initiation: ASIMTUFII 960 mg + Abilify Maintena 400 mg + oral aripiprazole 20 mg; or 14-day: 960 mg + 14 days oral aripiprazole 10–20 mg
May reduce to 720 mg q2mo for adverse reactions
May administer up to 2 weeks before/after the 2-month timepoint
CYP2D6 poor metabolizers: 720 mg q2mo

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