For U.S Residents only | Health Care Professionals
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.
Although suicidal behavior is difficult to predict, research scientists have found several factors that can increase the risk of recurrent suicide in people with schizophrenia.
These risk factors include:
People suffering from schizophrenia have a particularly high risk for suicide with 20% to 40% attempting suicide at some point during their lifetime. Research suggests that the risk is even higher for people diagnosed with schizoaffective disorder, an illness in which there are both severe mood swings (mania and/or depression), and some psychotic symptoms of severe schizophrenia.
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