CLOZARIL® (clozapine) is an atypical antipsychotic indicated for:
WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.
Most common adverse reactions (≥5%) were: CNS reactions (sedation, dizziness/vertigo, headache, and tremor); cardiovascular reactions (tachycardia, hypotension, and syncope); autonomic nervous system reactions (hypersalivation, sweating, dry mouth, and visual disturbances); gastrointestinal reactions (constipation and nausea); and fever.
To report SUSPECTED ADVERSE REACTIONS, contact HLS at (844) 457-8721; or FDA at (800) FDA-1088 or https://www.fda.gov/medwatch.Required Laboratory Testing Prior to Initiation and During Therapy
Re-Initiation of Treatment
Anticholinergic Toxicity – When possible, avoid use with other anticholinergic drugs and use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions.
Cognitive and Motor Performance (Interference) – Advise caution when operating machinery, including automobiles.
Eosinophilia – Assess for organ involvement (e.g., myocarditis, pancreatitis, hepatitis, colitis, nephritis). Discontinue if these occur.
Fever – Evaluate for infection and for neutropenia, or NMS.
Gastrointestinal Hypomotility with Severe Complications: – Severe gastrointestinal adverse reactions have occurred with the use of CLOZARIL. If constipation is identified, close monitoring and prompt treatment is advised.
Fever – Evaluate for infection and for neutropenia, NMS.
Hepatotoxicity – Can be fatal. Monitor for hepatotoxicity. Discontinue treatment if hepatitis or transaminase elevations combined with other symptoms occur.
Metabolic Changes – Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include:
Neuroleptic Malignant Syndrome (NMS) – Immediately discontinue and monitor closely. Assess for co-morbid conditions.
Pulmonary Embolism (PE) – Consider PE if respiratory distress, chest pain, or deep vein thrombosis occur.
QT Interval Prolongation – Can be fatal. Consider additional risk factors for prolonged QT interval (disorders and drugs).
Nursing Mothers: Discontinue drug or discontinue nursing, taking into consideration importance of drug to mother.
Pneumonia and other Inflammatory Conditions – Published case reports describe examples where pneumonia or other inflammatory conditions may increase clozapine concentrations. The clinical significance, the impact of treatments to modulate this inflammation, and mechanism of this potential increase in clozapine concentrations have not been fully characterized but may involve reduced cytochrome P450 1A2 activity.
For additional safety information, please see full Prescribing Information, including Boxed WARNING, which can be found at clozaril.com or www.clozapinerems.com.
For more information please contact:
HLS Therapeutics (USA), Inc.
(844) 457-8721
MLR: 2023HER002
Distributed by:
HLS Therapeutics (USA), Inc.
Rosemont, PA 19010
(844) 457-8721
© 2024 HLS Therapeutics (USA), Inc.
MLR: USA 20240210
CLOZARIL and Clozaril plus Torch are Registered Trademarks of Novartis AG
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