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FazaClo® FAQ (Frequently Asked Questions)
What are FazaClo® Orally Disintegrating Tablets? FazaClo (clozapine, USP) Orally Disintegrating Tablets are prescribed to treat patients with schizophrenia who do not respond well to traditional medications. The tablets are designed to disintegrate in the mouth in about 15 to 30 seconds -- they are then swallowed with the saliva. FazaClo tablets have a pleasant flavor, and can be taken discreetly, like a mint. FazaClo Orally Disintegrating Tablets have been shown to be bioequivalent to Novartis Pharmaceuticals Corporation’s Clozaril® tablets on a milligram for milligram basis. (Clozaril® is a registered trademark of Novartis Pharmaceuticals Corporation) When were FazaClo Orally Disintegrating Tablets approved? Fazaclo Orally Disintegrating Tablets received approval for marketing in the United States by the Food and Drug Administration in February 2004. What makes FazaClo Orally Disintegrating Tablets unique? FazaClo Orally Disintegrating Tablets are well suited for active patients getting on with their lives because they offer considerable convenience. The tablets disintegrate quickly in the mouth and may be taken discreetly since no liquids are required for administration. How are FazaClo Orally Disintegrating Tablets prescribed? Fazaclo Orally Disintegrating Tablets are available in 25 mg and 100 mg tablets. The dosage is determined by the health care practitioner on an individual basis. For treatment to be successful the patient must follow the doctor’s dosage instructions -- under no circumstances should the patient take more than the prescribed dose. FazaClo is available by prescription only through enrolled health care practitioners and pharmacies. FazaClo will be dispensed only to registered patients with current white blood cell (WBC) count and absolute neutrophil count (ANC) reports as specified in the package insert. Regular blood tests will be required. Click here to read more about Dispensing FazaClo. FazaClo Orally Disintegrating Tablets are packaged in individual blisters and should remain in the unopened blister until the time of use. The tablet should not be pushed through the foil. Just prior to use, peel back the foil from the blister and gently remove the tablet, being careful not to crush it. Immediately place the tablet in the mouth and allow it to disintegrate fully before swallowing. No liquid is needed. If FazaClo tablets are split in half in order to deliver a half dose, the unused half-tablet should be safely destroyed. What should be done in case dosing is interrupted? When restarting treatment with FazaClo Orally Disintegrating Tablets, even after a brief interval of interrupted dosing (i.e., two days or more since the last dose), it is recommended that the patient contact his or her health care practitioner for instructions. The patient should contact his or her health care practitioner before discontinuing FazaClo or stopping or starting any other medication. How should FazaClo Orally Disintegrating Tablets be stored? FazaClo tablets should be stored at room temperature (59–86º F, 15-30º C) and protected from moisture. Tablets should not be removed from the blister until immediately before use. FazaClo tablets should be kept out of the reach of children. What are some of the possible serious side effects of FazaClo Orally Disintegrating Tablets? All medications carry with them the risk of side effects. The risks are the same with FazaClo Orally Disintegrating Tablets as with any other form of clozapine. Should any side effect occur, including those listed below, report this to your health professionals right away. They will tell you whether the side effect can be expected to disappear as you get used to your medication, or they may ask you to adjust your dosage. Agranulocytosis (a drop in white blood cell levels) is among the most serious side effects associated with clozapine therapy. Accordingly, Azur Pharma provides the FazaClo Patient Registry, a free service to assist your health professionals in managing your blood counts. When you were given your prescription for FazaClo, your health professional enrolled you in the registry. While taking clozapine, your blood will be tested for its white blood cell count and absolute neutrophil count every week, every other week, or every four weeks. You should immediately report to your health practitioner any feelings of slowing down, weakness, fever, sore throat, sick-type feelings, mouth sores, or other possible signs of infection. Pay particular attention to reporting any flu-like complaints or other symptoms that might suggest you have an infection. Other serious adverse reactions that have been reported include: Seizure: There is a risk of developing seizures while taking FazaClo treatment, so you should avoid driving and any other hazardous activity while taking the medication. People with a history of seizures are also more likely to experience seizures with FazaClo therapy. Myocarditis: The first month of therapy is also the period of greatest risk for a type of inflammation of the heart muscle called myocarditis. Thus, if you experience fatigue, rapid breathing, are easily out of breath, or have periods of sudden rapid heart beats, report these symptoms to your health professionals immediately. Other Adverse Cardiovascular and Respiratory Effects: Especially in the beginning of treatment when your health professional is adjusting your dosage, there is a risk of feeling faint or dizzy when you stand up. This is called “orthostatic hypotension.” Therefore, during those first weeks, take your time getting out of bed or rising from a chair. Rapid or irregular heartbeat or difficulty breathing may also occur and may require a reduction in your dosage of FazaClo Orally Disintegrating Tablets, or treatment with an added medication. Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs have an increased risk for death. FazaClo is not approved for treatment of patients with dementia-related psychosis. Other: For further details about other potential adverse effects of FazaClo, see the General Information section of the website. Other reported side effects not listed here may be found in the prescribing information. Click here to view the Package Insert. What are the ingredients of FazaClo Orally Disintegrating Tablets? The active ingredient of FazaClo tablets is clozapine. Inactive ingredients can be found in the Package Insert. FazaClo tablets also contain phenylalanine (a component of aspartame more commonly known as Nutrasweet® or Equal®) and should not be taken by phenylketonurics (individuals who are unable to break down phenylalanine).
Clozaril® is a registered trademark of Novartis Pharmaceuticals Corporation. |