MEDICATION GUIDE

CLOZAPINE ORAL DISINTEGRATING TABLETS (CLOZAPINE ODT) (kloe′ za peen)

for oral use

CLOZAPINE ODT 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 ODT 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 ODT is causing your symptoms and may send you to see a blood specialist (hematologist). Tell your health care provider right away if you have any of the following symptoms or signs of neutropenia or infection:

• feel like you have the flu
• fever or chills
• feel extremely tired or weak
• sores or ulcers inside your mouth, gums, or on your skin
• sores or pain in or around your rectal area

• wounds that take a long time 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 “What should I avoid while taking Clozapine ODT?”
• 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 ODT can increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and dementia. Clozapine ODT is not for treatment of elderly people with dementia-related psychosis.

Clozapine ODT is 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 ODT is safe and effective in children.

Do not take Clozapine ODT if you:

• are allergic to clozapine or any of the ingredients in Clozapine ODT. See the end of this Medication Guide for a complete list of ingredients in Clozapine ODT.

• 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) which causes plaque
  build-up in arteries, or triglycerides, or low levels of “good” cholesterol (HDL-C) which helps remove excess cholesterol from the arteries
• 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 ODT
• use products containing caffeine
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you become pregnant while taking Clozapine ODT.
  • If you become pregnant while receiving Clozapine ODT, 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 ODT 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 ODT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

• Clozapine ODT and other medicines may affect each other causing side effects.
• Your healthcare provider can tell you if it is safe to take Clozapine ODT with your other medicines. Do not start or stop any medicines while taking Clozapine ODT 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.

• Take Clozapine ODT exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Clozapine ODT unless your healthcare provider tells you to. Talk to your healthcare provider or pharmacist if you are not sure how to take Clozapine ODT.
• If you miss taking Clozapine ODT 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.
• Take Clozapine ODT with or without food.
• See the detailed Instructions for Use at the end of this Medication Guide for information on how to take Clozapine ODT.
• If you take too much (overdose) Clozapine ODT, 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 ODT 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

• You should not drink alcohol while taking Clozapine ODT 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 ODT affects you.

Clozapine ODT can cause serious side effects, including:

• See "What is the most important information I should know about Clozapine ODT?"
• falls. Clozapine ODT 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 ODT, 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 ODT 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 ODT can cause a high count of eosinophils in some people and can be serious. This is a different risk than the risk of Clozapine ODT causing an abnormally low white blood cell count (neutropenia). Your health care 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 ODT. 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 ODT. Extremely high blood sugar can lead to coma and death. If you have diabetes or risk factors for diabetes (such as being overweight), your health care provider should check your blood sugar before you start Clozapine ODT and during treatment. Tell your healthcare provider if you have any of these symptoms of high blood sugar while taking Clozapine ODT:

• 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 ODT.
• 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 ODT 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 ODT. If you have a fever, your healthcare provider will do blood tests to check for neutropenia or an infection. Your healthcare provider may also send you to see a blood specialist (hematologist). Tell your healthcare provider if you have a fever.

• blood clot in your lung (pulmonary embolism) or in the veins of your legs (deep vein thrombosis). Get emergency help right away if you have symptoms of a blood clot including:

• chest pain and shortness of breath
• swelling or pain in your leg, ankle or foot
• warm feeling in the skin of your affected leg
• changes in your skin color such as turning pale or blue

• a problem that includes dry mouth, increased sweating, increased pulse rate, constipation, and urinary retention (anticholinergic toxicity).
• problems  thinking  clearly  and  moving your body. See What should I avoid while taking Clozapine ODT?”
• uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia). Tardive dyskinesia may not go away, even if you stop Clozapine ODT. Tardive dyskinesia may also start after you stop taking Clozapine ODT.
• stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.

The most common side effects of Clozapine ODT include:

• sleepiness or drowsiness
• dizziness
• heart and blood vessel problems
• fast heartbeat
• passing out (syncope)
• increased sweating
• vision problems

• headache
• shaking movements (tremors)
• low blood pressure
• having a lot of saliva in your mouth
• dry mouth
• constipation and nausea
• fever

• These are not all the possible side effects of Clozapine ODT.
• Your healthcare provider may lower your dose or temporarily or permanently stop treatment with Clozapine ODT if you have certain symptoms or if your WBC count is low.
• Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
• You may report side effects to FDA at 1-800-FDA-1088.

• Store Clozapine ODT at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Clozapine ODT bottle in a sealed blister until time of use.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Clozapine ODT for a condition for which it was not prescribed. Do not give Clozapine ODT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider (including pharmacist) for information about Clozapine ODT that is written for health professionals.

Active ingredient: clozapine

Inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol

Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054