Clozapine - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Clozapine. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS, AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS, AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Severe Neutropenia VERSACLOZ has caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating VERSACLOZ treatment, obtain baseline ANC(s). VERSACLOZ initiation is not recommended in patients with a baseline ANC less than 1500/µL (less than 1000/µL for those with Benign Ethnic Neutropenia (also known as Duffy-null associated neutrophil count)). See recommendations for dosage modifications based on ANC levels during VERSACLOZ treatment [see Dosage and Administration (2.4, 2.5)] . Consider a hematology consultation before initiating VERSACLOZ or during VERSACLOZ treatment [see Warnings ad Precautions ] . Orthostatic Hypotension, Bradycardia, Syncope Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day, or when restarting patients who have had even a brief interruption
5 WARNINGS AND PRECAUTIONS Severe neutropenia: See Boxed Warning Gastrointestinal Hypomotility with Severe Complications: Severe gastrointestinal adverse reactions have occurred with the use of VERSACLOZ.
If constipation is identified, close monitoring and prompt treatment is advised .
Eosinophilia: Assess for organ involvement (e.g., myocarditis, pancreatitis, hepatitis, colitis, nephritis).
Discontinue if these occur .
QT Interval Prolongation: Can be fatal.
Consider additional risk factors for prolonged QT interval (disorders and drugs) .
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk.
These metabolic changes include: Hyperglycemia and Diabetes Mellitus: Monitor for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.
Monitor glucose regularly in patients with diabetes or at risk for diabetes .
Dyslipidemia: Undesirable alterations in lipids have occurred in patients treated with atypical antipsychotics .
Weight Gain: Significant weight gain has occurred.
Monitor weight gain .
Neuroleptic Malignant Syndrome (NMS): Immediately discontinue and monitor closely.
Assess for co-morbid conditions .
Hepatotoxicity: Can be fatal.
Monitor for hepatotoxicity.
Discontinue treatment if hepatitis or transaminase elevations combined with other symptoms occur .
Fever: Evaluate for infection, and for neutropenia, NMS .
Pulmonary Embolism (PE): Consider PE if respiratory distress, chest, pain, or deep vein thrombosis occurs .
Anticholinergic Toxicity: When possible, avoid use with other anticholinergic drugs and use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions ( 5.16 , 7.1 ).
Interference with Cognitive and Motor Performance: Advise caution when operating machinery, including automobiles .
5.1 Severe Neutropenia VERSACLOZ has caused severe neutropenia (absolute neutrophil count (ANC) less than 500/μL) [see Adverse Reactions (6.1, 6.2)] and is associated with an increased risk of serious and potentially fatal infections.
Severe neutropenia occurred in a small percentage of VERSACLOZ-treated patients.
The risk of severe neutropenia appears greatest during the first 18 weeks of VERSACLOZ treatment.
The mechanism by which VERSACLOZ causes neutropenia is unknown.
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