IMPORTANT SAFETY INFORMATION

Clozapine tablets are contraindicated in patients with a history of Clozapine-induced agranulocytosis or severe granulocytopenia. Clozapine tablets are contraindicated in patients with previous hypersensitivity to Clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson syndrome) or any other component of Clozapine tablets.

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THIS IS A VERY IMPORTANT TIME IN YOUR LIFE

 

 

You and your family have been working hard to deal with your schizophrenia, and you’ve been taking medication to help—but your schizophrenia has not been completely under control. With your doctor’s help you’ve switched medications a couple of times, but you still haven’t experienced the additional improvement you’ve been hoping for. Now it’s time to see if a different medication can help.

CLOZAPINE IS A MEDICATION THAT MAY BE ABLE TO HELP

Clozapine is a prescription medicine for the treatment of severely ill patients with schizophrenia, a serious mental illness, who are not helped by other medicines for schizophrenia (treatment-resistant schizophrenia). It should be used only after other standard drugs for schizophrenia have either failed or caused serious side effects.

  • Clozapine is also used for reducing the risk of suicide in patients with schizophrenia or schizoaffective disorder who have attempted suicide in the past and may be at risk of suicidal behavior again.
  • Clozapine was the first of a class of treatments called atypical antipsychotic agents and, over the years, studies have shown that Clozapine is an effective treatment option for some patients.

IMPORTANT INFORMATION

You should not take Clozapine if you:

  • Have had blood problems called agranulocytosis or severe granulocytopenia after taking Clozapine.
  • Are allergic or had an allergic reaction (photosensitivity, vasculitis, erythema multiforme, or Stevens‐Johnson syndrome) to Clozapine or any of the ingredients of Clozapine.


IMPORTANT SAFETY INFORMATION

Indication

Clozapine is a prescription medicine for the treatment of severely ill patients with schizophrenia, a serious mental illness, who are not helped by other medicines for schizophrenia (treatment-resistant schizophrenia). It should be used only after other standard drugs for schizophrenia have either failed or caused serious side effects. Clozapine is also used for reducing the risk of suicide in patients with schizophrenia or schizoaffective disorder who have attempted suicide in the past and may be at risk of suicidal behavior again.

Important Safety Information

  • Agranulocytosis. Clozapine therapy can cause a severe decrease in white blood cells, called agranulocytosis which could lead to a serious infection and death. You should report any signs or symptoms to your doctor that may be associated with agranulocytosis or infection such as fever; mouth sores; skin, throat, vaginal, kidney, bladder or lung infection.

    Because of the risk of agranulocytosis, Clozapine is available only through a restricted program called the Clozapine Patient Registry. Prescribers, patients, and pharmacies must enroll in the program. Your doctor will schedule frequent blood tests while taking Clozapine so that he/she can monitor and make sure you are not developing agranulocytosis. You must have your blood tested before beginning treatment with Clozapine. If your results are acceptable after weekly blood tests for the first 6 months of treatment, you may be able to have your blood tested every other week for the next 6 months. After that, testing once each month might be possible. Your doctor will determine how often you will need testing. When stopping treatment with Clozapine for any reason, blood tests will continue on a weekly basis for 4 weeks.

  • Orthostatic Hypotension, Bradycardia, and Syncope: Clozapine can cause your blood pressure to drop suddenly, called orthostatic hypotension, which can make you feel dizzy or lightheaded and can lead to fainting (syncope) when you change position, such as standing or sitting up after lying down. This can also cause you to stop breathing or your heart to stop beating. Tell your doctor if you have heart disease or any other cardiovascular or cerebrovascular problems or are taking medicine for hypertension, or high blood pressure or have experienced dehydration. Follow your doctor’s instructions for dosage and administration. Contact your doctor immediately if you feel faint, lose consciousness, or have any signs or symptoms suggestive of low heart rate or abnormal heart beat.

  • Seizures. There is a high risk of having seizures during Clozapine treatment. Tell your doctor if you have a history of seizures or are at risk for seizures. Alcohol abuse while taking Clozapine may increase the risk of seizures. You should avoid driving or doing any other dangerous activity while taking Clozapine.

  • Myocarditis and Cardiomyopathy. Clozapine can cause an inflammation of the heart muscle, known as cardiomyopathy and myocarditis, which can be life-threatening. Tell your doctor if you experience any chest pain, difficulty breathing, an increase in heart rate, palpitations, fever, flu-like symptoms, or low blood pressure. Patients with Clozapine-related myocarditis or cardiomyopathy should not take Clozapine again.

  • Elderly patients with a mental illness called dementia-related psychosis and who are taking antipsychotic drugs, such as Clozapine, are at a higher risk of death. Clozapine is not approved for use in these patients.

  • You should not take Clozapine if you:
    • Have had blood problems called agranulocytosis or severe granulocytopenia after taking Clozapine.
    • Are allergic or had an allergic reaction (photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson syndrome) to Clozapine or any of the ingredients of Clozapine.
  • Eosiniphilia. Clozapine treatment can cause eosinophilia, or an increase in the number of white blood cells. This usually occurs during the first month of treatment and has been associated with inflammation of the heart, pancreas, liver, colon and kidneys. If it is suspected, Clozapine should be discontinued immediately.

  • QT Prolongation. Clozapine treatment is associated with abnormal heartbeat that can become life-threatening. Tell your doctor if you, or anyone in your family, have had any heart problems. You should not use Clozapine with other medicines that are known to cause any heart problems. Notify your doctor if you feel faint, lose consciousness or have abnormal heartbeat.

  • Neuroleptic Malignant Syndrome (NMS). Clozapine can cause NMS, a condition that can be life-threatening. Tell your doctor right away if you have high fever, stiff muscles, confusion, sweating, or changes in your heart rate or blood pressure.

  • Pulmonary Embolism. Pulmonary embolism (blood clot in the lungs) and deep vein thrombosis have occurred in patients treated with Clozapine. Patients should report pain in their legs (deep vein thrombosis), shortness of breath, chest pain or other respiratory signs and symptoms to their doctor.

  • Anticholinergic Toxicity. Clozapine should be used with caution in patients who have narrow-angle glaucoma, are taking other anticholinergic medications, or have enlarged prostates. Clozapine can result in gastrointestinal adverse reactions, which may be fatal, including constipation, fecal impaction, or paralytic ileus. Tell your doctor if you have ever had any eye, prostate or colon problems and about all of the medications you are taking.

  • Tardive Dyskinesia (TD). Clozapine can cause TD, a serious, sometimes permanent, condition in which you have uncontrolled movements of the face or other parts of the body. The risk for developing TD can increase over time with more medicine, but can also develop within a short time and at low doses. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped.

  • Metabolic Changes (hyperglycemia and diabetes mellitus, dyslipidemia, weight gain). Clozapine is associated with metabolic changes that require specific monitoring. The risks include hyperglycemia and diabetes mellitus, dyslipidemia, weight gain, and cardiovascular reactions. Clozapine can cause an increase in the amount of glucose, or sugar, in your blood, called hyperglycemia. Your doctor may check your blood sugar level before you start taking Clozapine and periodically during treatment. Tell your Doctor right away if you have any of the following symptoms while taking Clozapine: you are very thirsty, urinate very often, are very hungry, have blurry vision, or feel weak. Tell your doctor if you have diabetes or if you are at risk for diabetes (because of obesity or because someone in your family has diabetes).Abnormal lipids or cholesterol levels have occurred in patients treated with Clozapine. Weight gain has also occurred with the use of Clozapine. Monitoring of weight and cholesterol levels at baseline and during Clozapine therapy is recommended.

  • Effect on Behavior and or Physical Abilities. Clozapine can affect how you think or behave and/or your physical abilities, and may make you feel sleepy and less alert, especially during the first few days of treatment. Do not drive or operate heavy machinery until you know how Clozapine affects you. Ask your doctor when it would be okay to do these activities.

  • Missed Doses and Re-initiating Treatment. Tell your doctor if you miss a dose of Clozapine for more than two days. You should not restart your medication, and contact your doctor for dosing instructions.

  • Pregnancy and Nursing. Clozapine should be used in pregnancy only if the potential benefit is greater than the potential risk to the fetus. Tell your doctor if you are pregnant or plan to become pregnant. You should not breastfeed while taking Clozapine.

  • Use with Other Medications. Tell your doctor about all of the medicines you are taking, including over-the-counter medicines. There is a potential that the drugs could interact with each other.

  • Clozapine, USP Orally Disintegrating Tablets contain phenylalanine (a component of aspartame).

  • Common Side Effects. The most common side effects of Clozapine are feeling drowsy or sleepy, feeling dizzy or lightheaded, headache, trembling, fast heart rate, low blood pressure, fainting, excess salivation, sweating, dry mouth, vision changes, constipation, nausea, and fever.

This does not discuss all of the risks associated with Clozapine. Please see the accompanying full Prescribing Information, including Boxed Warnings, for the complete risks associated with Clozapine use. If you would like more information, talk with your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 800.FDA.1088.