Brexpiprazole is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis.
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-
Related 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 clinically appropriate
Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain
Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing Brexpiprazole if a clinically significant decline in WBC occurs in absence of other causative factors
Orthostatic Hypotension and Syncope: 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
Dosage Adjustments for Hepatic Impairment: For patients with moderate to severe hepatic impairment, the maximum recommended dosage is 2 mg once daily for patients with MDD, and 3 mg once daily for patients with schizophrenia
Dosage Adjustments for Renal Impairment: For patients with moderate, severe or end-stage renal impairment (creatinine clearance ClCr<60 mL/minute), the maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia
Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients
Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, concomitant diseases, and other drug therapy.
Benzodiazepine antagonist
Store Brexpiprazole tablets at 20°C to 25°C; excursions permitted to 15°C to 30°C
