Clozaril (Clozapine) Drug Information: Medication Guide and Patient Information

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May 26, 2012

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Schizophrenia facts

Schizophrenia is a chronic, severe, debilitating mental illness that affects about 1% of the population, more than 2 million people in the United States alone.
With the sudden onset of severe psychotic symptoms, the individual is said to be experiencing acute schizophrenia. Psychotic means out of touch with reality or unable to separate real from unreal experiences.
There is no known single cause of schizophrenia. As discussed later, it appears that genetic factors produce a vulnerability to schizophrenia, with environmental factors contributing to different degrees in different individuals.
There are a number of various treatments for schizophrenia. Given the complexity of schizophrenia, the major questions about this disorder (its cause or causes, prevention, and treatment) are unlikely to be resolved in the near future. The public should beware of those offering "t...

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PATIENT INFORMATION

Physicians are advised to discuss the following issues with patients for whom they prescribe CLOZARIL:

Patients who are to receive CLOZARIL should be warned about the significant risk of developing agranulocytosis. Patients should be advised to report immediately the appearance of lethargy, weakness, fever, sore throat, malaise, mucous membrane ulceration or other possible signs of infection. Particular attention should be paid to any flu-like complaints or other symptoms that might suggest infection.
- Patients should be informed that CLOZARIL tablets will be made available only through a special program designed to ensure the required blood monitoring in order to reduce the risk of developing agranulocytosis. Patients should be informed that their WBC count and ANC will be monitored as follows:
  - Weekly blood tests are required for the first 6 months.
  - If acceptable WBC counts and ANCs (WBC ≥ 3500/mm³ and ANC ≥ 2000/mm³) have been maintained during the first 6 months of continuous therapy, then WBC counts and ANCs can be monitored every 2 weeks for the next 6 months.
  - Thereafter, if acceptable WBC counts and ANCs have been maintained during the second 6 months of continuous therapy, WBC counts and ANCs can be monitored every 4 weeks.
Patients should be informed of the significant risk of seizure during CLOZARIL treatment, and they should be advised to avoid driving and any other potentially hazardous activity while taking CLOZARIL.
Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration.
Patients should be informed that if they miss taking CLOZARIL for more than 2 days, they should not restart their medication at the same dosage, but should contact their physician for dosing instructions.
Patients should notify their physician if they are taking, or plan to take, any prescription or over-the-counter drugs or alcohol.
Patients should notify their physician if they become pregnant or intend to become pregnant during therapy.
Patients should not breast-feed an infant if they are taking CLOZARIL.