For U.S Residents only | Health Care Professionals
CLOZARIL is available only from pharmacies registered with the CNR (CLOZARIL National Registry).
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