Classes
DEA Class; Rx
Common Brand Names; Abilify, Abilify Maintena, Abilify MyCite, Aristada, Aristada Initio
- Antipsychotcs, 2nd Generation;
- Antimanic Agents
Description
Used orally in adults for schizophrenia, bipolar I disorder, and as an adjunct for major depression; short-acting injection used for agitation; distinct extended-release IM injections are used for maintenance of selected indications; used orally in pediatric patients for schizophrenia, bipolar I disorder, Tourette’s syndrome, or irritability due to autism
Boxed warning related to an increased risk of suicidality in children, adolescents, and young adults, as well as regarding increased mortality risk in elderly patients treated for dementia-related psychosis
Indications
Indicated for the treatment of schizophrenia.
Contraindications
Hypersensitivity to aripiprazole
Adverse Effects
Weight gain (8-30%)
Headache (27%)
Agitation (19%)
Insomnia (18%)
Anxiety (17%)
Nausea and vomiting (11-15%)
Akathisia (10-13%)
Lightheadedness (11%)
Constipation (10-11%)
1-10%
Dizziness (10%)
Dyspepsia (9%)
Somnolence (5-8%)
Fatigue (6%)
Restlessness (6%)
Tremor (6%)
Dry mouth/xerostomia (5%)
Extrapyramidal disorder (5%)
Orthostatic hypotension (1-5%)
Musculoskeletal stiffness (4%)
Abdominal discomfort (3%)
Blurred vision (3%)
Cough (3%)
Pain (3%)
Myalgia (2%)
Rash
Rhinitis
Aripiprazole lauroxil
- Extrapyramidal symptoms (5-7%)
- Injection site reactions (4%)
- Pain at injection site (<2%)
- Increased weight (<2%)
- Increased creatinine phosphokinase (<2%)
- Akathisia (<2%)
- Headache (<2%)
- Insomnia (<2%)
- Restlessness (<2%)
Warnings
Risk of extrapyramidal symptoms (EPS) (eg, pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia; monitor
Tardive dyskinesia may occur; may consider discontinuation of therapy if clinically indicated
Use may be associated with neuroleptic malignant syndrome (NMS); monitor for mental status changes, fever, muscle rigidity and/or autonomic instability
May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy
Use caution in patients with known cardiovascular disease, cerebrovascular disease, or predisposition to hypotension; may increase incidence of cerebrovascular adverse reactions (eg, stroke, transient ischemic attack, including fatalities)
Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope
Use caution in patients with Parkinson disease; may aggravate motor disturbances
May increase risk of suicidal tendencies in children and adolescents (see Black Box Warnings)
FDA warning regarding off-label use for dementia in elderly (see Black Box Warnings)
Patients may act on dangerous impulses (eg, gambling)
Monitor for orthostatic hypotension
May cause seizures or convulsions; use cautiously in patients with history of seizures or with conditions that lower the seizure threshold
Pregnancy and Lactation
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA during pregnancy
Aripiprazole is present in human breast milk; there are reports of poor weight gain in breastfed infants exposed to aripiprazole and reports of inadequate milk supply in lactating women taking aripiprazole; development and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
Maximum Dosage
30 mg/day PO tablets and 25 mg/day PO oral solution; 30 mg/day immediate-release IM; 400 mg/month extended-release IM (Abilify Maintena); 882 mg/month extended-release IM (Aristada); 675 mg IM single-dose administration (Aristada Initio).
30 mg/day PO tablets and 25 mg/day PO oral solution; 30 mg/day immediate-release IM; 400 mg/month extended-release IM (Abilify Maintena); 882 mg/month extended-release IM (Aristada) and 675 mg IM single-dose administration (Aristada Initio) but safety and efficacy of Aristada and Aristada Initio have not established in geriatric adults over 65 years of age.
Weight greater than or equal to 50 kg: 30 mg/day PO for schizophrenia and bipolar disorder; 15 mg/day PO for autism; 20 mg/day PO for Tourette’s syndrome; safety and efficacy of the immediate-release (Abilify) and extended-release IM injections (Abilify Maintena, Aristada, Aristada Initio) have not been established.
Weight less than 50 kg: 30 mg/day PO for schizophrenia and bipolar disorder; 15 mg/day PO for autism; 10 mg/day PO for Tourette’s syndrome; safety and efficacy of the immediate-release (Abilify) and extended-release IM injections (Abilify Maintena, Aristada, Aristada Initio) have not been established.
Greater than or equal to 10 years and weighing greater than or equal to 50 kg: 30 mg/day PO for bipolar disorder; 15 mg/day PO for autism; 20 mg/day PO for Tourette’s syndrome; not indicated for schizophrenia.
Greater than or equal to 10 years and weighing less than 50 kg: 30 mg/day PO for bipolar disorder; 15 mg/day PO for autism; 10 mg/day PO for Tourette’s syndrome; not indicated for schizophrenia.
6 to 9 years weighing greater than or equal to 50 kg: 15 mg/day PO for autism; 20 mg/day PO for Tourette’s syndrome; not indicated for bipolar disorder or schizophrenia.
6 to 9 years weighing less than 50 kg: 15 mg/day PO for autism; 10 mg/day PO for Tourette’s syndrome; not indicated for bipolar disorder or schizophrenia.
Less than 6 years: Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Aripiprazole
tablet
- 2mg
- 5mg
- 10mg
- 15mg
- 20mg
- 30mg
tablet, embedded with ingestible event marker (IEM) sensor (Abilify MyCite)
- 2mg
- 5mg
- 10mg
- 15mg
- 20mg
- 30mg
Abilify MyCite system is composed of the following components:
- Aripiprazole tablet embedded with an ingestible event marker (IEM) sensor
- MyCite patch (wearable sensor) that detects the signal from the IEM sensor after ingestion and transmits data to a smartphone
- MyCite APP, a smartphone application (app) which is used with a compatible smartphone to display information for the patient
- Web-based portal for healthcare professionals and caregivers
oral disintegrating tablet
- 10mg
- 15mg
oral solution
- 1mg/mL
extended-release injectable IM suspension (Abilify Maintena)
- 300mg/vial or prefilled dual chamber syringe
- 400mg/vial or prefilled dual chamber syringe
extended-release injectable IM suspension (aripiprazole lauroxil [Aristada])
- 441mg/prefilled syringe (300 mg of aripiprazole)
- 662mg/prefilled syringe (450 mg of aripiprazole)
- 882mg/prefilled syringe (600 mg of aripiprazole)
- 1064mg/prefilled syringe (724 mg of aripiprazole)
extended-release injectable IM suspension (aripiprazole lauroxil [Aristada Initio])
- 675mg/2.4mL prefilled syringe (459 mg of aripiprazole)