Fazaclo

Fazaclo is a prescription medication used to treat the symptoms of schizophrenia. It is also used to reduce suicidal behavior in patients with schizophrenia or schizoaffective disorder.

Fazaclo is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

This medication comes in an orally disintegrating tablet (tablet that dissolves quickly in the mouth) and is taken usually one to two times a day. Do not divide or break orally disintegrating tablets. Let the tablet disintegrate in the mouth. The tablets can be allowed to disintegrate, or they may be chewed.

Common side effects of Fazaclo include sedation, tachycardia (fast heartbeat), and constipation.

Fazaclo can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Fazaclo affects you.

Fazaclo is a prescription medication used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to reduce suicidal behavior in patients with schizophrenia or schizoaffective disorder who have not been helped by other medications or who have tried to kill themselves and are likely to try to kill or harm themselves again.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Jazz Pharmaceuticals, Inc.

Serious side effects have been reported with Fazaclo. See the “Fazaclo Precautions” section.

Common side effects of Fazaclo include the following:

• sedation
• dizziness/vertigo
• headache
• tremor
• tachycardia (fast heartbeat)
• low blood pressure
• syncope  (fainting or “passing out”)
• hypersalivation (drooling)
• sweating
• dry mouth
• visual disturbances
• constipation
• nausea
• fever

This is not a complete list of Fazaclo side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• drugs that can cause an arrhythmia called Torsades des Point such as
  • certain anti­-arrhythmia medications including procainamide, sotalol (Betapace), quinidine, dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
  • certain fluoroquinolone antibiotics including levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
  • certain macrolide antibiotics including clarithromycin (Biaxin), erythromycin (EES, others)
  • certain azole antifungals including ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
  • certain antidepressants including amitriptyline, desipramine (Norpramin), imipramine (Tofranil), doxepin (Silenor), fluoxetine (Prozac, Sarafem), sertraline (Zoloft), venlafaxine (Effexor XR)
  • certain antipsychotics including haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon)
  • and other medications including cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig, arsenic (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine)
• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin, St John's wort, and nimodipine (Nimotop)
• medications that block the enzyme CYP1A2 such as zileuton (Zyflo), amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), propafenone (Rythmol), verapamil (Calan, Covera, Isoptin), cimetidine (Tagamet), famotidine (Pepcid), birth control pills, acyclovir (Zovirax), ticlopidine (Ticlid), ciprofloxacin (Cipro), and fluvoxamine (Luvox)
• medications that increase the activity of the enzyme CYP1A2 such as montelukast (Singulair), phenytoin (Dilantin, Phenytek), omeprazole (Prilosec, Zegerid), phenobarbital
  • cigarette smoking increases the activity of the enzyme CYP1A2
• medications that block a protein in the body (CYP2D6) such as quinidine, fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril), and paroxetine (Paxil)
• medications that use the enzyme CYP2D6 such as desipramine, dextromethorphan, atomoxetine

Serious side effects have been reported with Fazaclo including the following:

• Agranulocytosis, a blood disorder that can lead to serious infections and death. Agranulocytosis means that you do not have enough of certain white blood cells to fight infection. Tell your healthcare provider right away if you have any of the following symptoms of agranulocytosis:

  • Infection, including skin, throat, urinary tract, vaginal, pneumonia, or any other infection
  • Fever or chills
  • Sores or ulcers inside your mouth, gums or on your skin
  • Wounds that take a long time to heal
  • Feel like you have the flu
  • Pain or burning while urinating
  • Unusual vaginal discharge or itching
  • Abdominal pain
  • Sores or pain in or around your rectal area
  • Feel extremely tired or weak

If you have symptoms of agranulocytosis you will need to have a blood test right away to check if Fazaclo is causing your symptoms. You must have frequent blood tests while taking Fazaclo so your healthcare provider can make sure you are not getting agranulocytosis.

Your blood counts will be reported to a special program called The Clozapine REMS Program. You will receive each refill of Fazaclo only if you have a blood test and your blood test result is acceptable to your healthcare provider.

During your first 6 months of Fazaclo treatment, you will have weekly blood tests. If you have not taken Fazaclo or clozapine before, you will need weekly blood tests when you first start Fazaclo. If you have acceptable blood test results during your first 6 months of Fazaclo treatment, you can have a blood test every other week for the next 6 months. After a year of acceptable blood test results, you can have blood tests every 4 weeks.

• Decreased blood pressure (orthostatic hypotension), slow heart rate (bradycardia), or fainting (syncope) that can lead to death. Lightheadedness or fainting caused by a sudden change in your heart rate and blood pressure when you rise too quickly from a sitting or lying position can happen while you take Fasacloz and can be life threatening. These problems may happen more often when you are first starting treatment with Fazaclo or when your dose is increased.
• Seizures. Take caution when driving or when engaging in any other potentially hazardous activity while taking this medication.
• Myocarditis (heart muscle inflammation) and cardiomyopathy (heart muscle weakness) that may lead to death. Tell your healthcare provider if you have all or some of the following symptoms:
  • chest pain
  • fast heartbeat
  • shortness of breath
  • dizziness
  • swollen legs, ankles, and feet
  • feel tired
  • fever
• Higher risk of death in elderly people with memory loss (dementia) or psychosis. Fazaclo can increase the risk of death in elderly people who have dementia. Fazaclo is not for treating psychosis in elderly people with dementia.
• high count of a certain white blood cell (eosinophilia)
• problems with your heartbeat. These heart problems  (such as QT interval prolongation) can cause death. Call 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
• high blood sugar (diabetes) and changes in the fat levels in your blood (dyslipidemia)
• Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who take Fazaclo. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms:
  • high fever
  • excessive sweating
  • stiff muscles
  • confusion
  • changes in your breathing, heartbeat and blood pressure
• fever. Some people may have a fever that comes and goes while they take Fazaclo. This happens more often in the first 3 weeks you take Fazaclo. Talk to 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 and constipation (anticholinergic toxicity)
• problems thinking clearly and moving your body
• uncontrolled movements of your tongue, face, mouth, or jaw ( tardive dyskinesia)
• stroke in elderly people (cerebrovascular problems)

Do not take Fazaclo if you:

• History of clozapine-induced agranulocytosis or severe granulocytopenia
• Known hypersensitivity to clozapine or any other component of Fazaclo

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fazaclo, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking Fazaclo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Fazaclo to any of its ingredients
• 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
• have or have had liver or kidney problems
• have or have had seizures or epilepsy
• have or have had low levels of potassium or magnesium in your blood
• have diabetes
• have increased pressure in your eyes (glaucoma)
• have had Neuroleptic Malignant Syndrome (NMS)
• have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
• have or have had diarrhea or constipation
• have or have had an enlarged prostate gland
• smoke tobacco
• plan to stop smoking tobacco while taking Fazaclo
• use products containing caffeine
• if you have phenylketonuria (Fazaclo contains phenylalanine)
• are pregnant or plan to become pregnant. It is not known if Fazaclo will harm your unborn baby. Call your healthcare provider right away if you become pregnant while taking Fazaclo
• are breastfeeding or plan to breastfeed. Fazaclo 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 Fazaclo. Do not breastfeed while taking Fazaclo.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. 

Fazaclo falls into category B. There are no well-done studies that have been done in humans with Fazaclo. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. It is not known if Fazaclo will harm your unborn baby. Because animal reproduction studies are not always predictive of human response, Fazaclo should be used during pregnancy only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Fazaclo has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Fazaclo, a choice should be made whether to stop nursing or to stop use of this medication. Women should not breastfeed if they are taking Fazaclo. 

Take Fazaclo exactly as prescribed. Read the label carefully.

• Before starting Fazaclo, your doctor will obtain your complete blood cell counts. 
• Tablets rapidly disintegrate after placement in the mouth and may be chewed if desired. No water is needed. Can be administered with or without food 
• Fazaclo orally disintegrating tablets should be immediately placed in the mouth after removing the tablet from the blister pack or bottle. The tablet disintegrates rapidly after placement in the mouth. The tablets can be allowed to disintegrate, or they may be chewed. They may be swallowed with saliva. No water is necessary for administration.
• The orally disintegrating tablets in a blister pack should be left in the unopened blister until the time of use. Just prior to use, peel the foil from the blister and gently remove the orally disintegrating tablet. Do not push the tablets through the foil, because this could damage the tablet.
• If abrupt discontinuation of Fazaclo is necessary (because of agranulocytosis or another medical condition, for example), you need to be monitored carefully for the recurrence of your medical condition's symptoms and side effects related to cholinergic rebound, such as profuse sweating, headache, nausea, vomiting and diarrhea.
• If Fazaclo is missed for more than 2 days, do not restart Fazaclo at the same dosage. Instead, contact your physician for dosing instructions.

Fazaclo will be made available only through a special program designed to ensure the required blood monitoring in order to reduce the risk of developing agranulocytosis. Your doctor will monitor your absolute neutrophil counts (ANC). 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• how your respond to the medication
• your blood work
• other medications you are taking
• your kidney and liver function

The recommended starting dose of Fazaclo is 12.5 mg once daily or twice daily. 

• The total daily dose can be increased in amounts of 25 mg to 50 mg per day, if well-tolerated, to achieve a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of 2 weeks. Afterwards, the dose can be increased once weekly or twice weekly, in amounts of up to 100 mg. The maximum dose is 900 mg per day. 

If you take too much Fazaclo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

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.