Aripiprazole lauroxil LAI
ARISTADA
Pronunciation: ay-ri-PIP-ra-zoel lawr-OX-il (air-is-TAH-da)
“Airy stadium”
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
Read the full label on DailyMed ↗
| 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)
Available strengths
- inj 441, 662, 882, 1064 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 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.
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 441 mg | inj | per unit | — | $1007.59/mL | not offered |
| 662 mg | inj | per unit | — | $1006.57/mL | not offered |
| 882 mg | inj | per unit | — | $1004.18/mL | not offered |
| 1064 mg | inj | per unit | — | $993.60/mL | not offered |
Other forms: Aripiprazole lauroxil LAI (ARISTADA INITIO)
⚠ 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.