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Updated Monitoring Guidelines

We have recently updated the CLOZAPINE Prescription Access System (CPAS) to conform with changes in the prescribing information for The Mylan Brand of Clozapine.

As of July 15, 2005, all patients registered with CPAS must have Absolute Neutrophil Count (ANC) values reported together with test results for White Blood Cell (WBC) counts.  To make this process easier for you, we have provided an ANC calculator.

Frequency-of-monitoring guidelines have also changed.  The new prescribing information allows patients who have completed 1 year of continuous therapy with The Mylan Brand of Clozapine with no abnormal blood event (all results for WBC ≥3500/mm3 and ANC ≥2000/mm3) to be monitored every 4 weeks.  Please see Courtesy Reminders and Alerts, which have been revised to conform to the updated monitoring guidelines.

Click here to review a table that summarizes treatment parameters.

Click here to review the flow chart outlining the guidelines for tracking patients after interruption in therapy.

Click here to download the updated CPAS Overview with a quick summary reference sheet.

Please remember that your ongoing participation in CPAS is based upon: (1) complete familiarity with the current Clozapine Prescribing Information; (2) enrollment of patients in CPAS to reduce the potential of rechallenging patients at risk; and (3) enrollment in a local quality assurance committee.

We hope you find these updates and improvements beneficial for patient management.

Agranulocytosis, granulocytopenia, seizures, orthostatic hypotension, tachycardia, myocarditis, drowsiness, and dizziness have been reported in patients taking clozapine.  For more information, please see accompanying full Prescribing Information, which includes BOXED WARNINGS.


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