Prescribing
Informations
Therapist plus two
Isn't Clozapine worth a
little extra effort?

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 for some time now. 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

Doctors prescribe Clozapine for the management of patients with schizophrenia after they’ve tried two or more medications for schizophrenia and have not been helped by these medications (a condition called treatment-resistant schizophrenia).

Clozapine should be used only after at least two 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 are allergic or had an allergic reaction to Clozapine or its ingredients
  • you’ve been told you have a blood problem
  • you have seizures or fits that medicine cannot control
  • you have an obstruction in your bowels or severe constipation
  • you have a slowed heart rate, sleepiness, slowed breathing or coma from any cause
  • you are taking medicines that cause blood problems

PLEASE SEE IMPORTANT SAFETY INFORMATION BELOW

Indication

Clozapine is a prescription medicine for the management 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 at least two 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 agranulocytosis which is a severe decrease in white blood cells, which could lead to a serious infection. Agranulocytosis can be life-threatening. You must have frequent blood tests while taking Clozapine so that your doctor can keep checking to make sure you are not developing agranulocytosis. You must have your blood tested before beginning treatment with Clozapine and weekly for 4 weeks after stopping Clozapine treatment. 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.
  • 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. You should avoid driving or doing any other dangerous activity while taking Clozapine.
  • Myocarditis. Clozapine has caused an inflammation of the heart muscle, called myocarditis, which can be life-threatening. The risk of having myocarditis is highest during the first month of treatment but can continue throughout treatment. Patients with Clozapine-related myocarditis should not take Clozapine again.
  • Orthostatic Hypotension (dizziness or fainting). Clozapine can cause orthostatic hypotension (a rapid fall in blood pressure), which makes you feel dizzy or lightheaded and can lead to fainting 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.
  • Elderly patients with a severe mental illness called dementia-related psychosis and who are taking antipsychotic drugs, such as Clozapine (medicines to treat some mental illnesses), are at a higher risk of death. Clozapine is not approved for use in these patients.
  • You should not take Clozapine if you:
    • Are allergic or had an allergic reaction to Clozapine or any of the ingredients of Clozapine.
    • Have ever been told that you have a blood problem (myeloproliferative disorders)
    • Have seizures or fits that medicine cannot control (uncontrolled epilepsy).
    • Have obstruction of the intestine or bowel where food cannot pass through (paralytic ileus). Notify your doctor if you experience severe constipation
    • Have had blood problems called agranulocytosis or severe granulocytopenia after taking Clozapine.
    • Have severe central nervous system (CNS) depression (i.e. sleepiness, slowed breathing, slowed heart rate, or unconsciousness) or coma from any cause.
    • Are taking medicines that are known to cause agranulocytosis, a serious blood problem, or medicines that affect bone marrow. Tell your doctor about all of the medicines that you have taken or are taking now.
  • QT Prolongation. Clozapine treatment is associated with abnormal heartbeats that can be life-threatening. Tell your doctor if you have had any heart problems. You should not use Clozapine with other medicines that are known to cause any heart problems.
  • 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 pulse, heart rate or blood pressure.
  • 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.
  • Hyperglycemia and Diabetes. Clozapine can cause hyperglycemia, or increases in the amount of glucose, or sugar, in your blood. Your doctor may check your blood sugar level before you start taking Clozapine and while you are taking it to check for increases (or worsening) in the amount of glucose, or sugar levels, in your blood. 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). Your doctor may do tests to check your blood sugar levels before and during treatment with Clozapine.
  • Dyslipidemia and Weight Gain. Clozapine is associated with weight gain and metabolic changes that may increase the risk of having a heart attack or stroke (cardiovascular or cerebrovascular risk). Undesirable changes in lipids or cholesterol levels have occurred in patients treated with Clozapine. Monitoring of weight and lipids at baseline and periodically during Clozapine therapy is recommended. Weight gain has also occurred with the use of Clozapine
  • Pregnancy and Nursing. Mothers taking Clozapine during the third trimester of pregnancy may cause the newborn to develop a syndrome that may include symptoms such as tremors, muscle rigidity, agitation, loss of muscle tone, drowsiness, breathing difficulties, and feeding disorders in these infants. Symptoms may resolve by themselves, or may need intensive care support and longer hospitalizations. 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.
  • Missed Dose. Tell your doctor if you miss a dose of Clozapine for more than two days, or if you are taking any other medications, especially for anxiety, depression, or mood change.
  • Other Cautions. Clozapine can affect how you think or behave and/or your physical abilities, especially during the first few days of treatment. Clozapine can make you feel drowsy and may make you less alert. Be careful not to do any activity, such as driving, that you need to be alert to do safely. Do not drink alcohol while taking Clozapine
  • 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, having a lot of saliva in your mouth, sweating, dry mouth, changed vision, fast heartbeat, low blood pressure, fainting, 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.

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