Indicated for:

• Treatment of schizophrenia in adults 

• Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults

• Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR (cariprazine) is not approved for the treatment of patients with dementia-related psychosis.

In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke.

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors. The safety and effectiveness of VRAYLAR have not been established in pediatric patients.

The maximum recommended dose is 6 mg daily for treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder. The maximum recommended dose is 3 mg daily for treatment of depressive episodes associated with bipolar I disorder.

VRAYLAR may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy. Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest during initial dose titration and when increasing the dose.

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

Usage of VRAYLAR is not recommended in patients with severe hepatic impairment (Child-Pugh score between 10 and 15). Usage of VRAYLAR is not recommended in patients with severe renal impairment (CrCL < 30 mL/minute).

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with administration of antipsychotic drugs.

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs, including VRAYLAR.

VRAYLAR should be prescribed in a manner most likely to reduce the risk of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients: 1) who suffer from a chronic illness that is known to respond to antipsychotic drugs; and 2) for whom alternative,effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, use the lowest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. Periodically reassess the need for continued treatment.

Leukopenia and neutropenia have been reported during treatment with antipsychotic agents, including VRAYLAR.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Dysphagia has been reported with VRAYLAR.

Atypical antipsychotic drugs, including VRAYLAR, have caused metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain.

Atypical antipsychotics cause adverse alterations in lipids.

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

Atypical antipsychotics may disrupt the body’s ability to reduce core body temperature. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use VRAYLAR with caution in patient who may experience these conditions.

Like other antipsychotic drugs, VRAYLAR may cause seizures.

The development of cataracts was observed in nonclinical studies.

Weight gain has been observed with use of atypical antipsychotics, including VRAYLAR.

Concomitant use of VRAYLAR with a strong CYP3A4 inhibitor (e.g. itraconazole, ketoconazole) increases
the exposures of cariprazine and its major active metabolite.

Concomitant use of VRAYLAR with a CYP3A4 inducer (e.g. rifampin, carbamazepine) is not recommended.

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Based on animal data, VRAYLAR may cause fetal harm.

The major active metabolite of cariprazine, DDCAR, has been detected in adult patients up to 12 weeks after discontinuation of VRAYLAR.

GoToSource

• Dosage greater than 6 mg daily for treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder and dosage greater than 3 mg daily for treatment of depressive episodes associated with bipolar I disorder. GoToSource 

• Use in patients under the age of 18. GoToSource 

• Dementia-related psychosis. GoToSource

Extrapyramidal symptoms (tremor, slurred speech and involuntary muscle movements), akathisia (urge to move), dyspepsia (indigestion) and vomiting. GoToSource

Insomnia and weight gain. GoToSource 

Somnolence/sedation and prolongation of the electrocardiogram (ECG) QT interval. GoToSource 

Seizures, hyponatremia (low sodium level in the blood), increased blood pressure, exacerbation of schizophrenia and psychosis. GoToSource  

Increased mortality in elderly patients with dementia-related psychosis. GoToSource

Dyslipidemia (abnormal amount of lipids in blood), hyperglycemia (high blood sugar), neuroleptic malignant syndrome (life-threatening drug reaction), metabolic abnormalities, low white blood cell count, orthostatic hypotension, cognitive and motor impairment and changes in body temperature. GoToSource

No major injury lawsuits reported.