May 19, 2005

Clozapine Monthly Monitoring Announced

FDA Grants Monthly WBC Monitoring for FazaClo(R) (clozapine, USP); Patient Registry for FazaClo Orally Disintegrating Tablets Already Configured for Convenient New Monitoring Schedule

From a company Marketing/Press release:


In a move that will bring added convenience to thousands of clozapine patients and healthcare providers, Alamo Pharmaceuticals' FazaClo (clozapine, USP) -- a product for patients with treatment-resistant schizophrenia - may now offer monthly safety monitoring.

Like all products containing the active ingredient clozapine, treatment with FazaClo is monitored prior to filling each prescription and refill in order to limit the risk of agranulocytosis, a rare but serious side effect that affects the blood. As each FazaClo patient's blood tests show acceptable white blood cell counts, the data is arrayed in the computerized FazaClo(R) Patient Registry(R) database, and the patient's pharmacist then releases the next prescription.

This regulatory action shows expanded confidence in the safety of FazaClo as an alternative that brings previously unresponsive patients with schizophrenia a chance for a new, more normal life. Acting on a review of long term patient data showing that the rare blood effect most often appears during the first 12 months of treatment, the monthly monitoring schedule relieves patients and care providers of the need for weekly or bi-weekly testing once the patient has had 12 continuous months of acceptable WBC (white blood cell counts).

   Prescribing Information

Please log on to to consult full Prescribing Information including BOXED WARNINGS regarding agranulocytosis, seizures, myocarditis, and other adverse cardiovascular and respiratory effects.
Phenylketonurics: FazaClo Orally Disintegrating Tablets contain phenylalanine.

   Because of the risk of agranulocytosis and granulocytopenia associated with the use of clozapine, Alamo Pharmaceuticals has developed a monitoring system called the FazaClo(R) Patient Registry(R). Prescribing physicians, dispensing pharmacists and FazaClo (clozapine, USP) patients must be registered in the FazaClo Patient Registry which will compare patient information against the National Non-Rechallenge Masterfile and maintain a continuing record of WBC values and related information for all patients who receive FazaClo Orally Disintegrating Tablets.

   Alamo Pharmaceuticals

   FazaClo is a product of Alamo Pharmaceuticals. The company's headquarters is in Beverly Hills, CA, and its office for pharmaceutical operations and sales is in Parsippany, New Jersey.

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