For U.S Residents only | Health Care Professionals
CLOZARIL therapy usually starts with a low daily dose, which is then slowly increased until the level that works best is found. The health care prescriber will carefully monitor up to a certain point the person’s symptoms and the drug’s effects, and may change the dosage as often as every day during the first few weeks of treatment. Determining the right dose of CLOZARIL can take as long as 6 to 8 weeks.
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