Physicians are advised to discuss the following issues with patients (and/or their guardians) for whom they prescribe Apo-Clozapine.

• Patients who are to receive Apo-Clozapine should be warned about the significant risk of developing agranulocytosis, a potentially life-threatening adverse event. They should be informed that regular blood tests are required to monitor for the occurrence of agranulocytosis, and that Apo-Clozapine tablets will be made available only through a special program designed to ensure the required blood monitoring. 

They should also be informed that weekly blood tests will be required for the first 26 weeks of their treatment with clozapine and that, following this initial higher risk period, they could be allowed to change to a once every 2 weeks schedule, provided that their clinical condition is permitting such a change in monitoring regimen. 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 advised to contact their physician immediately if they develop persistent tachycardia (rapid heart rate) at rest accompanied by other signs and symptoms of heart failure (e.g. chest pain, shortness of breath, swelling of the ankles and feet, or arrhythmias (abnormal heart rhythms). Other symptoms which may be present in addition to the above include fatigue, flu-like symptoms, fever that is otherwise unexplained, hypotension (low blood pressure) and/or raised jugular venous pressure (bulging neck veins when sitting or standing). Patients are advised to contact their physician before discontinuing any medication.
  
  
• Patients should be informed of the significant risk of seizure during Apo-Clozapine treatment and should be advised to avoid activities that require alertness (e.g., driving, operating machinery, swimming, climbing, etc.). 
  
  
• 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 stop taking Apo-Clozapine for 2 days or more, they should not restart their medication at the same dosage, but should contact their physician for dosage 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 Apo-Clozapine.