FDA Grants Monthly WBC Monitoring for Clozapine
May 19, 2005 - 12:51:00 PM
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"Since FazaClo utilizes the newest and most sophisticated clozapine patient registry in the psychiatric marketplace, we were able to immediately update and configure the database to accept FDA's new monthly monitoring option-and to accommodate their request to include a routine blood count called ANC (absolute neutrophil count) for all patients."
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By Alamo Pharmaceuticals,
[RxPG] 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).
"Since FazaClo utilizes the newest and most sophisticated clozapine patient registry in the psychiatric marketplace, we were able to immediately update and configure the database to accept FDA's new monthly monitoring option-and to accommodate their request to include a routine blood count called ANC (absolute neutrophil count) for all patients" stated Paul Duffy, Alamo Pharmaceuticals' Executive Vice President of Operations. "This is all part of our on-going effort to provide unsurpassed support to mental health professionals and their patients."
How FazaClo Helps Enhance This New Convenience
Because FazaClo is the only Orally Disintegrating Tablet form of clozapine, it has some unique characteristics that add to patient convenience. The product has a minty taste that helps patients to remember when they took their medication, and because taking FazaClo looks like taking a breath mint, patients are less likely to call attention to their illness. And FazaClo Orally Disintegrating Tablets dissolve in 15-30 seconds on the tongue, so patients don't need to find water to take their medicine.
Research Shows Patients Like the FazaClo Orally Disintegrating Tablets(1)
In a study where patients were crossed over to FazaClo from ordinary clozapine tablets, 81% of patients said they liked their FazaClo Orally Disintegrating Tablets. This is important, because experts tell us that when patients like their medication, they are more likely to adhere to their therapeutic program and have better outcomes(2).
Prescribing Information
Please log on to http://www.fazaclo.com/ 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.
Publication:
U.S. Food and Drug Administration (FDA)
On the web:
www.fazaclo.com 
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Additional information about the news article
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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.
For more information please visit http://www.fazaclo.com/.
1. Randomized, open-label, multiple-dose, two-way crossover comparison of relative bioavailability of Alamo Pharmaceuticals FazaClo (clozapine,USP) Orally Disintegrating Tablets to Clozaril(R)* Tablets under fasting conditions following multidose administration of 100 mg every 12 hours in 33 patients with schizophrenia. In this study, FazaClo was administered without any liquids and Clozaril was administered with liquids. Patients completed a questionnaire noting their impression of the mint-flavored FazaClo Orally Disintegrating Tablet.
2. Data on file, Alamo Pharmaceuticals, LLC. *Clozaril(R) is a registered trademark of Novartis Pharmaceutical Corporation.
CONTACT: Josh Weinstein, jwEinstein Strategic Messaging,+1-973-927-5674, or , for Alamo Pharmaceuticals [email protected]
Web site: http://www.fazaclo.com/
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