Zetazolex

Brand Name: Zetazolex 1mg Tablet

Composition

Each Zetazolex 1mg tablet contains: Brexpiprazole ..................................................... 1 mg.

Each Zetazolex 2mg tablet contains: Brexpiprazole ................................................... 2  mg

Each Zetazolex 3mg tablet contains: Brexpiprazole .................................................... 3 mg

Each Zetazolex 4mg tablet contains: Brexpiprazole ................................................... 4 mg.

Therapeutic Indications                

• is an atypical antipsychotic indicated for:

○          Use as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.

○          Treatment of schizophrenia in adults and pediatric patients ages 13 years and older.

Dosage and Administration:

Administer ZetaZolex once daily with or without food

• 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.
• Moderate, Severe, or End-Stage Renal Impairment (CrCl<60 mL/minute): Maximum recommended dosage is 2 mg once daily for
• patients with MDD and 3 mg once daily for patients with schizophrenia.
• Known CYP2D6 Poor Metabolizers: Reduce the usual dosage by half

Contraindications:       

• Known hypersensitivity to Zetazolex or any of its components

Warnings and precautions:            

• 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 Zetazolex 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.

Undesirable Effects:       

• Most common adverse reactions in adults 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).

Pharmacological Properties:       

The mechanism of action of brexpiprazole in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

Packaging:                

Zetazolex 1mg Tablets: Box containing 3 blisters of 10 tablets each.

Zetazolex 2mg Tablets: Box containing 3 blisters of 10 tablets each.

Zetazolex 3mg Tablets: Box containing 3 blisters of 10 tablets each.

Zetazolex 4mg Tablets: Box containing 3 blisters of 10 tablets each.