Aripiprazole monohydrate LAI
ABILIFY ASIMTUFII
“Asympify! (a spell to remove symptoms)”
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
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| 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
Available strengths
- inj 720, 960 mg (q2 months)
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.
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 720 mg | inj | per unit | — | $1785.23/mL | not offered |
| 960 mg | inj | per unit | — | $1782.93/mL | not offered |
Other forms: Aripiprazole (ABILIFY) · Aripiprazole monohydrate LAI (ABILIFY MAINTENA)
⚠ 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.
Active metabolites
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