Cariprazine

Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) were:

• Schizophrenia: extrapyramidal symptoms and akathisia
• Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness
• Bipolar depression: nausea, akathisia, restlessness, and extrapyramidal symptoms

• Strong CYP3A4 inhibitors: Reduce VRAYLAR dosage by half
• CYP3A4 inducers: Concomitant use is not recommended

• Cerebrovascular Adverse Reactions in Elderly Patients with DementiaRelated Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack)
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
• Tardive Dyskinesia: Discontinue if appropriate
• Late-Occurring Adverse Reactions: Because of VRAYLAR’s long halflife, monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and with each dosage change
• Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain
• Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia. Consider discontinuing VRAYLAR if a clinically significant decline in WBC occurs in absence of other causative factors
• Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope
• Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
• Potential for Cognitive and Motor Impairment: Use caution when operating machinery