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WBC Count and ANC Value Requirements and Monitoring Frequency

***Patients with moderate leukopenia are at an increased risk for agranulocytosis and should have a careful risk-benefit assessment to guide continued treatment.***

In order to start Clozaril, the WBC must be at least 3500 mm3, and the ANC must be at least 2000 mm3. Both values are required (P.I. 2005) in order to dispense Clozaril. For the first 6 months, the patients are required to have their blood work done weekly. The blood work result must be seen by the dispensing pharmacist prior to dispensing the drug. The blood work draw date may not be more than 7 days old in order for the pharmacist to dispense the medication. The pharmacist, after viewing the blood work, may dispense a 1-week’s supply of Clozaril. If the blood values (WBC and ANC) are not available to the pharmacist, Clozaril may not be dispensed.* Blood work must be reported to the CNR promptly (within 5 days of dispensing Clozaril).

This can be accomplished in two ways:
a) by visiting www.clozarilregistry.com and registering on-line for electronic submission OR
b) using the form entitled "White Blood Cell / Absolute Neutrophil Count Reporting Form"

After 6 months of continuous therapy with Clozaril without any interruptions [due to a low WBC and /or ANC, defined as a WBC<3000 mm3 and /or ANC<1500 mm3] or increased monitoring [WBC<3500 mm3 and /or ANC <2000 mm3], the patient may have their blood monitoring done every 14 days, and will be entitled to receive a 2-week supply of Clozaril. The blood work draw date may not be more than 7 days old in order for pharmacist to dispense the drug.

After 12 months of continuous therapy (6 months of continuous weekly followed by 6 months of continuous biweekly monitoring) with Clozaril without any interruptions [due to a low WBC and /or ANC, defined as a WBC<3000 mm3 and /or ANC<1500 mm3] or increased monitoring [or WBC<3500 mm3 and /or ANC<2000 mm3], the patient may have their blood monitoring done every 4 weeks, and will be entitled to receive a 4-week supply of Clozaril. The blood work draw date may not be more than 7 days old in order for pharmacist to dispense the drug.

In the event that a patient is discontinued from Clozaril, weekly blood work for 4 weeks (minimum) must be performed and reported to the CNR. *Please see full prescribing information.

 
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