For U.S Residents only | Health Care Professionals
If you or someone you care for has been diagnosed with treatment-resistant, severe schizophrenia, you should know about CLOZARIL and how it may help in the treatment of this type of mental illness.
The risk of suicide in the general population is about 1%. There is a 30 to 40 times increased risk of death from suicide in individuals who have previously attempted suicide compared with the general population. Schizophrenia is among other serious mental disorders that are predictors of recurrent suicide attempts.
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 1 (844) 457-8721; or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch
Required Laboratory Testing Prior to Initiation and During Therapy
Initiating Treatment
Eosinophilia, including, drug reaction with eosinophilia
and systemic symptoms syndrome (DRESS)
QT Interval Prolongation
Metabolic Changes
These metabolic changes include:
Neuroleptic Malignant Syndrome (NMS)
Assess for co-morbid conditions.
Hepatotoxicity
Fever
Pulmonary Embolism (PE)
Anticholinergic Toxicity
Gastrointestinal:
Interference with Cognitive and Motor Performance
Discontinuing Treatment
Re-Initiation of Treatment
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. 1 (844) 457-8721
May 2019 HLS Copyright 2019
CLOZARIL is a registered trademark of Novartis AG Logo is a registered trademark of HLS Therapeutics INC.
Approved for use 5/8/2019 MLR USA: 20190501
Distributed by:
HLS Therapeutics (USA), Inc.
Rosemont, PA 19010
(844) 457-8721
© 2016 HLS Therapeutics
2016J0630
November 2016
CLOZARIL and Clozaril plus Torch are Registered Trademarks of Novartis AG
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