For U.S Residents only | Health Care Professionals
The health care prescriber will decide on the best treatment, and will consider factors including symptoms experienced, current medical conditions, medications already being taken, and potential side effects that a new medication might cause.
Side effects vary from person to person and are not always the same for everyone.
People taking CLOZARIL might experience one or more of the following side effects:
Fever, weakness, infection symptoms
ORTHOSTATIC HYPOTENSION, BRADYCARDIA, & SYNCOPE
Low blood pressure, feeling faint, slow heart rate, and loss of consciousness
MYOCARDITIS AND CARDIOMYOPATHY
Inflammation or enlargement of the heart
INCREASED RISK OF DEATH IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
In addition to agranulocytosis (the most serious side effect associated with CLOZARIL), the following side effects have been reported:
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
Eosinophilia, including, drug reaction with eosinophilia
and systemic symptoms syndrome (DRESS)
QT Interval Prolongation
These metabolic changes include:
Neuroleptic Malignant Syndrome (NMS)
Assess for co-morbid conditions.
Pulmonary Embolism (PE)
Interference with Cognitive and Motor Performance
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
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