Brexpiprazole | Rexulti

REXULTI is an atypical antipsychotic indicated for:

  • Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) (1,14.1)
  • Treatment of schizophrenia (1,14.2)

Moderate to Severe Hepatic Impairment (Child-Pugh score ≥7): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia (2.3)

Moderate, Severe or End-Stage Renal Impairment (CLcr<60 mL /minute): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia (2.4)

Known CYP2D6 Poor Metabolizers: Reduce the usual dosage by half (2.5)

Dosage Forms and Strengths: Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3)

Rexulti

Brexpiprazole | Rexulti Prescribing Information Highlights

The following points are shortened, highlighted information from prescribing information for this drug. For the full prescribing information PDF, click the button below to be directed to the FDA PDF label for this drug.

BREXPIPRAZOLE | REXULTI FULL PRESCRIBING INFO PDF

—–INDICATIONS AND USAGE—–

  • See description above.

—–DOSAGE AND ADMINISTRATION—–

  • See description above.

—–CONTRAINDICATIONS—–

  • Known hypersensitivity to REXULTI or any of its components (4)

—–WARNINGS & PRECAUTIONS—–

  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack) (5.3)
  • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.4)
  • Tardive Dyskinesia: Discontinue if clinically appropriate (5.5)
  • Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain (5.6)
  • 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 REXULTI if a clinically significant decline in WBC occurs in absence of other causative factors (5.7)
  • 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 (5.8)
  • Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold (5.9)

—–ADVERSE REACTIONS—–

Most common adverse reactions were (6.1):

  • MDD: Weight increased and akathisia (≥5% and at least twice the rate for placebo)
  • Schizophrenia: Weight increased (≥4% and at least twice the rate for placebo)

—–USE IN SPECIFIC POPUALATIONS—–

Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure (8.1)

More Information on Brexpiprazole | Rexulti

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