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 this type of mental illness.
Results from the International Suicide Prevention Trial (InterSePT™) have demonstrated that CLOZARIL can reduce the risk of suicidal behavior in people with schizophrenia or schizoaffective disorder. People with schizoaffective disorder have symptoms of both schizophrenia and mood disorders, such as mental or physical mania (overactivity). CLOZARIL can reduce the risk of repeated suicidal behavior in schizophrenia or in people with schizoaffective disorder.
CLOZARIL is an atypical antipsychotic (a family of drugs used to treat people suffering from schizophrenia). CLOZARIL requires that people – and their health care prescribers – make a commitment to therapy. A blood disorder called agranulocytosis has been associated with CLOZARIL. In the disorder, white blood cells are not made – or not enough of them are made. This reduces the body’s resistance to infection. People who take CLOZARIL must have their WBC and ANCs monitored to prevent or greatly reduce the risk of developing agranulocytosis.
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