ARISTADA is indicated for the treatment of schizophrenia in adults. 

For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

In conjunction with the first ARISTADA injection, administer a single injection of ARISTADA INITIO and one dose of oral aripiprazole 30 mg, or continue treatment with oral aripiprazole for 21 consecutive days.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

ARISTADA is not approved for the treatment of patients with dementia-related psychosis.

Medication errors, including substitution and dispensing errors, between ARISTADA and ARISTADA INITIO could occur. ARISTADA INITIO is for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks.

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) may occur in association with antipsychotic drugs, including ARISTADA.

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome.

Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain.

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics.

Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.

Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors.

Aripiprazole may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. Patients at increased risk of these adverse reactions or at increased risk of developing complications from hypotension include those with dehydration, hypovolemia, treatment with antihypertensive medication, history of cardiovascular disease (e.g., heart failure, myocardial infarction, ischemia, or conduction abnormalities), history of cerebrovascular disease, as well as patients who are antipsychotic-naïve. In such patients, consider using a lower starting dose, and monitor orthostatic vital signs.

Antipsychotics including ARISTADA may cause somnolence, postural hypotension, or motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.

ARISTADA, like other antipsychotics, has the potential to impair judgment, thinking or motor skills.

In clinical trials and/or postmarketing experience, events of leukopenia and neutropenia have been reported temporally related to antipsychotic agents. Agranulocytosis has also been reported.

As with other antipsychotic drugs, use ARISTADA cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.

Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.

Use with strong CYP3A4 Inhibitor reduce the dose of ARISTADA to the next lower strength. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated. For patients known to be poor metabolizers of CYP2D6: Reduce dose to 441 mg from 662 mg, 882 mg, or 1064 mg. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated. Avoid use for patients at 662 mg, 882 mg, or 1064 mg dose.

Use with strong CYP2D6 Inhibitor reduce the dose of ARISTADA to the next lower strength. No dosage adjustment is necessary in patients taking 441 mg ARISTADA, if tolerated. Avoid use for patients at 662 mg, 882 mg, or 1064 mg dose.

With concomitant use of ARISTADA with a strong CYP3A4 inducer for more than 2 weeks consider increasing the ARISTADA dose.

The concomitant use of oral aripiprazole and carbamazepine decreased the exposure of aripiprazole compared to the use of oral aripiprazole alone.

Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents (e.g.,carvedilol, lisinopril, prazosin).

The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone. The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone.

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Animal studies: developmental toxicity.

Aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production.

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• Use in patients under 18 years of age and in patients over 65 years of age. GoToSource

• Use in patients with dementia-related psychosis. GoToSource

• Irritability associated with autism. GoToSource

• Depression, obsessive-compulsive disorder, post-traumatic stress disorder, personality disorders, tourette’s syndrome, autism, eating disorders, insomnia, attention-deficit hyperactivity disorder, anxiety, substance abuse, major depressive disorder and borderline personality disorder. GoToSource

⚠️  Patients with CYP2D6 gene results in higher systemic concentrations of Aristada and are at higher risk of adverse reactions.

Orthostatic hypotension (fall in blood pressure when upright position is assumed), increased mortality rate in elderly patients with dementia-related psychosis, stroke, neuroleptic malignant syndrome (life-threatening drug reaction), tardive dyskinesia (involuntary, repetitive body movements), hyperglycemia (high blood sugar), diabetes mellitus, dyslipidemia (high blood lipid (fat) levels), weight gain, leukopenia (low white blood cell count), neutropenia (low levels of neutrophils a type of white blood cell), agranulocytosis (low level of granulocytes a type of white blood cell), seizures, cognitive and motor impairment, disruption of body temperature regulation, anaphylactic reaction (potentially life-threatening allergic reaction), angioedema (swelling in deep layers of skin), laryngospasm (spasm of the vocal cords), pruritus (severe itching), urticaria (hives), pathological gambling and hiccups. GoToSource

Lawsuits filed for compulsive behaviors