General Clozapine Dispensing Information
TEVA clozapine is an FDA approved ("AB" rated) brand-equivalent version of Novartis Clozaril®. Clozapine is indicated for the treatment of severe schizophrenia in patients who fail standard therapy (see package insert for full prescribing information). Although clozapine has proven to be effective for this indication, there are potential serious side effects that require careful medical supervision. TEVA has developed the Clozapine Patient Registry to assist health care professionals in the monitoring of patients taking TEVA clozapine.
Patients must be registered with the TEVA Clozapine Patient Registry prior to dispensing TEVA clozapine. Patients must also be assigned to a dispensing pharmacy and a treating physician.
Prior to issuing an Eligibility Code/Patient ID, the TEVA Clozapine Patient Registry will conduct a rechallenge status check with the National Non-Rechallenge Masterfile on all patients new to clozapine, restarting clozapine, or if clozapine experience is unknown.
Once a patient is registered and eligibility is confirmed, a one, two or four week supply of TEVA clozapine can be dispensed per the physician's prescription and the patients monitoring frequency.
A current and acceptable WBC count and ANC value is required prior to dispensing clozapine and for 4 weeks after discontinuation of treatment.
To initiate treatment, the WBC count must be greater than 3,500/mm3 and the ANC value must be greater than 2,000/mm3. The lab report should be no older than 7 days from the date drug is dispensed and should be submitted to the TEVA Clozapine Patient Registry within 7 days of the blood draw date.
Monitoring Frequency Information
Table 1 in the Package Insert provides details on frequency of monitoring based on stage of therapy or results from WBC/ANC monitoring. Figure 2 in the Package Insert provides detail on resuming monitoring frequency after interruption in therapy. Click Here for more information.
Patients are monitored weekly for the first six months. If there are no low counts the patient can be monitored every two weeks for an additional six months. Afterwards, the patient may qualify for every 4 week monitoring with physician authorization.
Every 4 week monitoring requires Clozapine treatment for at least 1 year, every 2 week monitoring for at least the past 6 months, and acceptable WBC and ANC values over the past year (i.e., all WBC counts have been greater than or equal to 3,500/mm3 and all ANC values have been greater than or equal to 2,000/mm3).
Clozaril® is a registered trademark of Novartis AG.