Aripiprazole lauroxil LAI
ARISTADA INITIO
Pronunciation: ay-ri-PIP-ra-zoel lawr-OX-il (air-is-ta-da-i-NI-shee-oe)
“Innie show”
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
Read the full label on DailyMed ↗
| 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)
Available strengths
- inj 675 mg
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.
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 675 mg | inj | per unit | — | $1026.91/mL | not offered |
Other forms: Aripiprazole lauroxil LAI (ARISTADA)
⚠ BOXED WARNING
- Increased mortality in elderly patients with dementia-related psychosis
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityMetabolic effects, extrapyramidal symptoms/tardive dyskinesia and agent-specific QT or orthostatic risk.