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SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Clozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/μL. Severe neutropenia can lead to serious infection and death. Prior to initiating treatment with FAZACLO a baseline ANC must be at least 1500/μL for the general population; and must be at least 1000/μL for patients with documented Benign Ethnic Neutropenia (BEN). During treatment, patients must have regular ANC monitoring. Advise patients to immediately report symptoms consistent with severe neutropenia or infection (e.g., fever, weakness, lethargy, or sore throat) [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Because of the risk of severe neutropenia, FAZACLO is available only through a restricted program under a Risk Evaluation Mitigation Strategy (REMS) called the Clozapine REMS Program [see WARNINGS AND PRECAUTIONS].
Orthostatic Hypotension, Bradycardia, Syncope
Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages. Use FAZACLO cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications) [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Seizures have occurred with clozapine treatment. The risk is dose-related. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. Use caution when administering FAZACLO to patients with a history of seizures or other predisposing risk factors for seizure (CNS pathology, medications that lower the seizure threshold, alcohol abuse). Caution patients about engaging in any activity where sudden loss of consciousness could cause serious risk to themselves or others [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Myocarditis and Cardiomyopathy
Fatal myocarditis and cardiomyopathy have occurred with clozapine treatment. Discontinue FAZACLO and obtain a cardiac evaluation upon suspicion of these reactions. Generally, patients with FAZACLO-related myocarditis or cardiomyopathy should not be rechallenged with FAZACLO. Consider the possibility of myocarditis or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or ECG changes occur [see WARNINGS AND PRECAUTIONS].
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FAZACLO is not approved for use in patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS].
FAZACLO is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. FAZACLO tablets may be chewed.
Each orally disintegrating tablet contains clozapine equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg.
The active component of FAZACLO is clozapine. The remaining components are aminoalkyl methacrylate copolymer E, mannitol, aspartame, microcrystalline cellulose*, silicified microcrystalline cellulose**, crospovidone, natural and artificial mint flavor, sodium bicarbonate, citric acid, ferric oxide (yellow), and magnesium stearate.
*12.5, 25, and 100 mg tablets
**150 and 200 mg tablets
THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY INFANTS. PHENYLKETONURICS: CONTAINS PHENYLALANINE [see WARNINGS AND PRECAUTIONS]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.6 mg aspartame, thus, 0.87 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 3.1 mg aspartame, thus, 1.74 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 12.4 mg aspartame, thus, 6.96 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 18.6 mg aspartame, thus, 10.44 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 24.8 mg aspartame, thus, 13.92 mg phenylalanine. The allowable daily intake of aspartame is 50 mg per kilogram of body weight per day.
What are the possible side effects of clozapine (Clozaril, FazaClo)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with clozapine. Call your doctor right away if you have signs of infection such as:
- fever, chills, body aches, flu symptoms;
- mouth and throat ulcers;
- cough, sore throat;
- rapid heart rate; or
- rapid and shallow breathing.
Stop using clozapine and call your doctor at once if you have any of...
Last reviewed on RxList: 10/1/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Fazaclo Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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