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Dispensing FazaClo® The introduction of FazaClo® Orally Disintegrating Tablets offers health care practitioners a therapeutic gain in treating their 1) patients who are severely ill with schizophrenia and who fail to respond adequately to standard drug treatment and 2) patients with schizophrenia or schizoaffective disorder who are at risk of reexperiencing suicidal behavior. Although the efficacy of clozapine in treating schizophrenia has been demonstrated since its introduction in the United States, clozapine products are also associated with the risk of very serious side effects such as agranulocytosis. Click here to view Package Insert for full prescribing information. In order to assist in the early identification of persons experiencing reductions in their white blood cell counts, Azur Pharma has acquired the FazaClo® Patient Registry. In addition to providing a systematic way to promote proper monitoring of WBC counts in patients receiving FazaClo, this registry will identify patients who become non–rechallengeable while receiving FazaClo, listing them in the Clozapine National Non-Rechallenge Masterfile. Click here to read about the Clozapine National Non-Rechallenge Masterfile. FazaClo will be available to enrolled health care practitioners and pharmacies only. Click here to enroll a Health care practitioner or enroll a Pharmacy/Pharmacist. FazaClo will be dispensed only to registered patients with valid Patient Registration Numbers, a WBC count and ANC report within the requirements of the clozapine product labeling, and a prescription from an enrolled health care practitioner. Patients must also be assigned to a treating health care practitioner and dispensing pharmacy. Click here to Register a Patient. The FazaClo Patient Registry will verify that all patients new to FazaClo, restarting FazaClo, or with unknown experience are not included in the Clozapine National Non-Rechallenge Masterfile prior to issuing a Patient Registration Number. The patient’s pharmacy and health care practitioner will be notified of the patient’s non-rechallenge and registration status. After the patient eligibility and registration are confirmed, a one week, two week, or four week supply of tablets will be dispensed according to prescription instructions. Support to facilitate continuation of appropriate FazaClo treatment and monitoring for patients taking extended vacations will be provided, wherever possible. Click here to find out about Patient Vacation and Out-of-Town Management. For patients on FazaClo, WBC Count and ANC Monitoring Forms must be submitted to the FazaClo Patient Registry. For patients on a weekly monitoring schedule, WBC Count and ANC Monitoring Forms must be received within 7 days of the blood draw date. For patients on an every other week monitoring schedule, WBC Count and ANC Monitoring Forms must be received within 14 days of the blood draw date. For patients on an every four weeks monitoring schedule, WBC Count and ANC Monitoring Forms must be received within 28 days of the blood draw date. For patients on a more frequent monitoring schedule, forms must be submitted as soon as possible and not more than 7 days after the first blood draw date listed on the form. Click here to submit WBC count reports. Click here to learn more about WBC Monitoring Frequency. To facilitate broad and efficient data collection, the FazaClo Patient Registry has established multiple methods of data submission. Enrolled health care practitioners and pharmacies may submit registry data:
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