Substantial risk of potentially life-threatening agranulocytosis; reserve for use in the following indications: 1) for treatment of severely ill schizophrenic patients who fail to show an acceptable response to adequate courses of standard antipsychotic therapy, either because of insufficient efficacy or an inability to achieve an effective dosage due to intolerable adverse effects. 2) for reducing risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at risk of reexperiencing suicidal behavior.
Measure baseline WBC count and ANC before initiation of therapy and measure WBC count and ANC at regular intervals during treatment and for at least 4 weeks after discontinuance. (See Agranulocytosis under Cautions.)
Available only through distribution systems that ensure periodic monitoring of WBC count and ANC prior to provision of patient’s next supply of drug. (See Restricted Distribution under Dosage and Administration.)
Seizures
Risk of seizures, particularly at higher dosages. Use with caution in patients with a history of seizures or other predisposing factors. Avoid activity where sudden loss of consciousness could cause serious risk to patient or others. (See Seizures under Cautions.)
Myocarditis
Increased risk of fatal myocarditis, particularly during, but not limited to, first month of therapy. Promptly discontinue if myocarditis is suspected. (See Myocarditis under Cautions.)
Increased Mortality in Geriatric Patients
Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) compared with those receiving placebo (2.6%).
Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Other Cardiovascular and Respiratory Effects
Risk of orthostatic hypotension, with or without syncope, particularly during initial titration in association with rapid dosage escalation. Profound collapse may occur rarely, possibly accompanied by respiratory and/or cardiac arrest.
In patients who have had even a brief interruption of therapy (i.e., ≥2 days since last dose), reinitiate therapy at dosage of 12.5 mg once or twice daily. (See Reinitiation of Therapy under Dosage and Administration.)
Caution advised when initiating clozapine in patients receiving benzodiazepines or other psychotropic agents since collapse, respiratory arrest, and cardiac arrest reported during initial treatment in such patients. See Specific Drugs under Interactions.
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