Clozapine

What it is used for

Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior 1.1 Treatment-resistant Schizophrenia Clozapine Orally Disintegrating Tablets (Clozapine ODT) are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.

Because of the risks of severe neutropenia and of seizure associated with their use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment. The effectiveness of Clozapine ODT in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing Clozapine ODT and chlorpromazine in patients who had failed other antipsychotics.

1.2 Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorder Clozapine ODT is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state.

Suicidal behavior refers to actions by a patient that put him/herself at risk for death. The effectiveness of Clozapine ODT in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the InterSePT™ trial.

The most important thing to know

Clozapine tablets can cause serious side effects including: Severe neutropenia (low white blood cell (WBC) counts) that can lead to serious infections and death. Your healthcare provider will do WBC blood tests before starting treatment with clozapine tablets and weekly for the first 6 months. After your first 6 months of treatment, your healthcare provider will determine how frequent you will have blood tests.

If you have symptoms of severe neutropenia or an infection, your healthcare provider will do more frequent WBC blood test(s) to check if clozapine tablets are causing your symptoms and may send you to see a blood specialist (hematologist). Tell your healthcare provider right away if you have any of the following symptoms or signs of neutropenia or infection: wounds that take a long time to heal skin, throat, vaginal, urinary tract, or lung infection pain or burning while peeing unusual vaginal discharge or itching abdominal pain or bloating Orthostatic hypotension (decreased blood pressure), bradycardia (slow heart rate), or syncope (fainting) that can lead to death.

You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Tell your healthcare provider right away if you feel dizzy or pass out. Seizures. See “

How to take it

Take clozapine tablets exactly as your healthcare provider tells you to take them. Do not change your dose or stop taking clozapine tablets unless your healthcare provider tells you to. Talk to your healthcare provider or pharmacist if you are not sure how to take clozapine tablets. Take clozapine tablets with or without food.

If you miss taking clozapine tablets for 1 day or more, call your healthcare provider right away. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you take too many (overdose) clozapine tablets, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Symptoms of clozapine tablets overdose can include: feeling sleepy confusion coma fast or irregular heartbeat low blood pressure shallow or difficult breathing having a lot of saliva in your mouth seizures What should I avoid while taking clozapine tablets? You should not drink alcohol while taking clozapine tablets because it can increase your chances of getting serious side effects.

Do not drive, operate machinery, swim, climb, or do dangerous activities until you know how clozapine tablets affect you.

Side effects, and when to stop

Clozapine tablets can cause serious side effects, including: falls. Clozapine tablets may make you sleepy, dizzy, may cause a decrease in your blood pressure when changing positions, and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. slow emptying of your stomach and intestines (decreased gastric motility).

Severe constipation and bowel problems can happen and can lead to hospitalization, surgery, and death. You may not feel or be aware of constipation symptoms. Your healthcare provider will examine you for possible bowel problems. Tell your healthcare provider if you get any signs and symptoms of decreased gastrointestinal motility during treatment with clozapine tablets, including: having bowel movements less than normal hard or dry stools difficulty passing gas stomach bloating or pain nausea or vomiting Staying well hydrated, increasing physical activity, and taking fiber during treatment with clozapine tablets can help prevent constipation and other bowel problems.

Your healthcare provider may prescribe medicines to prevent severe problems. high count of a certain white blood cell (eosinophilia). Clozapine tablets can cause a high count of eosinophils in some people and can be serious. This is a different risk than the risk of clozapine tablets causing an abnormally low white blood cell count (neutropenia).

Your healthcare provider may send you to see an internal medicine specialist (internist) or blood specialist (hematologist). Tell your healthcare provider right away if you have any of these symptoms: feeling very tired or weak fever rash swelling joint pain coughing and wheezing nausea, vomiting, or diarrhea night sweats confusion difficulty swallowing serious heart rhythm problems (QTc Interval Prolongation) that can cause death.

Your healthcare provider will do a physical exam and may obtain blood tests and an electrocardiogram before starting you on treatment with clozapine tablets. Tell your healthcare provider right away if you have any of these symptoms: passing out or feeling like you will pass out dizziness feeling as if your heart is pounding or missing beats problems with your metabolism such as: high blood sugar (hyperglycemia) or diabetes.

Increases in blood sugar can happen in some people who take clozapine tablets. Extremely high blood sugar can lead to coma and death. If you have diabetes or risk factors for diabetes (such as being overweight), your healthcare provider should check your blood sugar before you start clozapine tablets and during treatment.

Tell your healthcare provider if you have any of these symptoms of high blood sugar while taking clozapine tablets: feel very thirsty need to urinate more than usual feel very hungry feel weak or tired feel sick to your stomach feel confused, or your breath smells fruity increased fat levels (cholesterol and triglycerides) in your blood (dyslipidemia).

Your healthcare provider should check the fat levels in your blood before you start and during treatment with clozapine tablets. weight gain. You and your healthcare provider should check your weight regularly. neuroleptic malignant syndrome (NMS). NMS is a rare but serious condition that can lead to death and must be treated in a hospital.

Tell your healthcare provider right away if you become severely ill and have any of these symptoms: high fever stiff muscles confusion changes in breathing, heartbeat, and blood pressure increased sweating liver problems. Clozapine tablets can cause serious life-threatening liver problems that can lead to death. Tell your healthcare provider right away if you have any of these symptoms: feeling tired loss of appetite nausea and vomiting yellowing of your skin or whites of your eyes pain on the right side of your stomach (abdomen) elevated bilirubin levels fever.

Some people may have a fever while they take clozapine tablets.

Who should not take it

Do not take clozapine tablets if you: are allergic to clozapine tablets or any of the ingredients in clozapine tablets. See the end of this Medication Guide for a complete list of ingredients in clozapine tablets. Before taking clozapine tablets, tell your healthcare provider about all your medical conditions, including if you: have or have had heart problems or a family history of heart problems including heart attack, heart failure, abnormal heart rhythm or long QT syndrome, or stroke have or have had low or high blood pressure have or have had kidney or liver problems have or have had seizures (convulsions) have or have had stomach or intestinal problems including constipation, slow emptying of your stomach, or diarrhea have or have had low levels of potassium or magnesium in your blood have or have had diabetes or high blood sugar in you or your family have or have had high levels of total cholesterol, “bad” cholesterol (LDL-C), or triglycerides, or low levels of “good” cholesterol (HDL-C) have increased pressure in your eyes (glaucoma), an enlarged prostate, or problems passing urine have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia) smoke tobacco plan to stop smoking tobacco while taking clozapine tablets use products containing caffeine are pregnant or plan to become pregnant.

Talk to your healthcare provider if you become pregnant while taking clozapine tablets. If you become pregnant while receiving clozapine tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/ are breast feeding or plan to breast feed.

Clozapine can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take clozapine tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Clozapine tablets and other medicines may affect each other causing side effects.

Your healthcare provider can tell you if it is safe to take clozapine tablets with your other medicines. Do not start or stop any medicines while taking clozapine tablets without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What to avoid

” Myocarditis (heart muscle inflammation), pericarditis (inflammation of outer layer of the heart) and cardiomyopathy (heart muscle weakness) that can lead to death. Symptoms of myocarditis, pericarditis, and cardiomyopathy include: chest pain fast heartbeat or palpitations shortness of breath fever flu-like symptoms feel tired or faint swollen legs, ankles, or feet Increased risk of death in elderly people with dementia-related psychosis.

Medicines like clozapine tablets can increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and dementia. Clozapine tablets are not for treatment of elderly people with dementia-related psychosis. What are clozapine tablets? Clozapine tablets are a prescription antipsychotic medicine used to treat people: Who are severely ill with schizophrenia not helped by other schizophrenia medicines With schizophrenia or schizoaffective disorder who have been suicidal and may be at risk of suicidal behavior again It is not known if clozapine tablets are safe and effective in children.

Storing it

Store clozapine tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep clozapine tablets and all medicines out of the reach of children.