FazaClo

Fazaclo can cause a serious blood condition. Your doctor will order certain lab tests before you start your treatment, during your treatment, and for at least 4 weeks after your treatment. Your doctor will order the lab tests once a week at first and may order the tests less often as your treatment continues. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; weakness; fever, sore throat, chills, or other signs of flu or infection; or sores in your mouth or throat.

A program has been set up to be sure that people do not take Fazaclo without the necessary monitoring. You, your doctor, and your pharmacist must be registered with the program, and your pharmacist will not dispense your medication unless he or she has received the results of your blood tests. Ask your doctor for more information about this program and how you will receive your medication.

Fazaclo may cause seizures. Tell your doctor if you have or have ever had seizures. Do not drive a car, operate machinery, swim, or climb while taking Fazaclo, because if you suddenly lose consciousness, you could harm yourself or others.

Fazaclo may cause myocarditis (swelling of the heart muscle that may be dangerous). If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; difficulty breathing or fast breathing; fever; chest pain; or fast, irregular, or pounding heartbeat.

Fazaclo may cause dizziness, lightheadedness, or fainting when you stand up, especially when you first start taking it or when your dose is increased. Tell your doctor if you are taking medications for anxiety such as diazepam (Valium), sleeping pills, or other medications for schizophrenia. Your doctor will probably start you on a low dose of Fazaclo and gradually increase your dose to give your body time to adjust to the medication and decrease the chance that you will experience this side effect. Talk to your doctor if you do not take Fazaclo for 2 days or longer. Your doctor will probably tell you to restart your treatment with a low dose of Fazaclo.

Use in Older Adults:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as Fazaclo have an increased chance of death during treatment.

Fazaclo is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed Fazaclo if you, a family member, or someone you care for has dementia and is taking this medication.

Clozapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Clozapine is used to treat severe schizophrenia. Clozapine is also used to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders. Clozapine is usually given after other medications have been tried without successful treatment of symptoms.

Clozapine may also be used for purposes not listed in this medication guide.

Clozapine is not for use in psychotic conditions related to dementia. Clozapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not take clozapine if you are allergic to it, or if you have untreated or uncontrolled epilepsy, a bone marrow disorder, paralytic ileus or intestinal blockage, a history of infection caused by taking clozapine, or if you are also using drugs that weaken your immune system (such as cancer medicine or steroids).

Clozapine can lower blood cells that help your body fight infections. This can make it easier for you to develop a serious or life-threatening infection. This risk is higher in women and older adults, and in people who are malnourished or have serious medical problems.

While you are taking clozapine, your blood will need to be tested often. Do not miss any follow-up visits to your doctor.

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 or throat ulcers, cough, sore throat, rapid heart rate, or rapid and shallow breathing.

There are many other medicines that can interact with clozapine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Your pharmacist can provide more information about clozapine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Clozapine is an antipsychotic medicine works by changing the actions of chemicals in the brain.

Clozapine is used to treat severe schizophrenia, or to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders.

Clozapine is available only from a certified pharmacy under a special program.

Clozapine may also be used for purposes not listed in this medication guide.

Clozapine can cause a serious heart problem, especially if you use certain medicines at the same time. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with clozapine.

Taking clozapine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with clozapine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• dolasetron, methadone, probucol, tacrolimus;

• an antibiotic--ciprofloxacin, enoxacin, erythromycin, pentamidine, rifampin;

• an antidepressant--citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline;

• anti-malaria medication--mefloquine, halofantrine;

• heart rhythm medicine--amiodarone, encainide, flecainide, procainamide, propafenone, quinidine, sotalol;

• medicine to treat a psychiatric disorder--chlorpromazine, droperidol, haloperidol, iloperidone, pimozide, thioridazine, ziprasidone; or

• seizure medication--carbamazepine, phenytoin.

This list is not complete and many other drugs can interact with clozapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

This section provides information on the proper use of a number of products that contain clozapine. It may not be specific to FazaClo. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not miss any doses.

This medicine comes with a patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the oral liquid or tablet with or without food.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or chew it as desired.

Shake the bottle of the oral liquid for 10 seconds before each use. Measure the dose with the dosing syringe that comes with the package. Wash the oral syringe with warm water after using it.

Drink plenty of fluids with this medicine to help prevent constipation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (disintegrating tablets, suspension, or tablets):
  • For schizophrenia or prevention of suicidal behavior:
    • Adults—At first, 12.5 milligrams (mg) per day, taken as a single dose or two times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 900 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss 2 or more days of clozapine doses, talk to your doctor before you start taking it again. You might have to restart the medicine at a lower dose than you were taking before.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not refrigerate or freeze the oral liquid. Throw away any unused medicine 100 days after opening the bottle for the first time.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Shakiness, trouble moving around, or stiffness.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Coughing up blood.
• Blue or very pale skin in the arms or legs.
• Feeling very tired or weak.
• Change in eyesight.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• Some people who take FazaClo may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if this medicine is stopped. Sometimes, signs may lessen or go away over time after FazaClo (clozapine orally disintegrating tablets) is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take this medicine or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about FazaClo, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about FazaClo. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using FazaClo.

Review Date: October 4, 2017

Treatment-Resistant Schizophrenia

FazaClo is 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 its use, FazaClo should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see Warnings and Precautions (5.1, 5.5)].

The effectiveness of clozapine in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics [see Clinical Studies (14.1)].

Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorder

FazaClo 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 in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the InterSePT™ trial [see Clinical Studies (14.2)].

                                                                                                  150 mg (Bottle)

NDC No. 18860-105-10

FazaClo®

(clozapine)

Orally Disintegrating Tablets

100 Tablets                                     Rx Only

                 150 mg

Phenylketonurics: Contains Phenylalanine, 10.44 mg per Tablet.

Usual Adult Dosage: Consult the package insert for prescribing information.

Storage Conditions: Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

KEEP OUT OF REACH OF CHILDREN.

Dispense: Dispensing should be contingent upon ANC results; quantities dispensed should not exceed the limits set forth in the full product labeling.

Distributed by Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304 USA.

U.S. Patent Nos. 6,024,981; 6,221,392; and 6,106,861.
FazaClo® is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries.