Versacloz

Versacloz 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.

Versacloz 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 suspension and is taken usually one to two times a day.

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

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

Versacloz 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 and 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 Versacloz. See the “Versacloz Precautions” section.

Common side effects of Versacloz include the following:

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

This is not a complete list of Versacloz 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 the prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) 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 (Rifadin), 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, Proquin), 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
• chemotherapy, radiation, or other medicines that cause agranulocytosis, low white blood cell count, or affect your bone marrow
• other antipsychotics or other medicines that can affect the amount of clozapine in your blood
• medicines used to treat anxiety, relax your muscles, or help you sleep
• any medicines that make you feel sleepy
• antibiotics
• medicines used to treat heart problems
• medicines used to lower the amount of water in your body (diuretics)
• medicines used for birth control

Serious side effects have been reported with Versacloz 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 Versacloz is causing your symptoms. You must have frequent blood tests while taking Versacloz 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 Versacloz only if you have a blood test and your blood test result is acceptable to your healthcare provider.

During your first 6 months of Versacloz treatment, you will have weekly blood tests. If you have not taken Versacloz or clozapine before, you will need weekly blood tests when you first start Versacloz. If you have acceptable blood test results during your first 6 months of clozapine 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 Versacloz and can be life threatening. These problems may happen more often when you are first starting treatment with Versacloz 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. Versacloz can increase the risk of death in elderly people who have dementia. Versacloz 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 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 Versacloz. 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 Versacloz. This happens more often in the first 3 weeks you take Versacloz. 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 Versacloz if you:

• have had blood problems called agranulocytosis, severe granulocytopenia, or neutropenia after taking clozapine
• are allergic to clozapine or any of the ingredients in Versacloz. 

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 Versacloz, there are no specific foods that you must exclude from your diet when receiving this medication. 

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

• are allergic to Versacloz or 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 Versacloz
• use products containing caffeine
• are pregnant or plan to become pregnant. It is not known if Versacloz will harm your unborn baby. Call your healthcare provider right away if you become pregnant while taking Versacloz
• are breastfeeding or plan to breastfeed. Versacloz 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 Versacloz. Do not breastfeed while taking Versacloz.

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. 

Versacloz falls into category B. There are no well-done studies that have been done in humans with Versacloz. 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 Versacloz will harm your unborn baby. Because animal reproduction studies are not always predictive of human response, Versacloz should be used during pregnancy only if clearly needed.

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

Versacloz has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Versacloz, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. Talk to your healthcare provider about the best way to feed your baby if you take Versacloz. Do not breastfeed while taking Versacloz.

Take Versacloz exactly as prescribed. Do not change your dose or stop taking Versacloz without talking to your healthcare provider.

• If you miss a dose of Versacloz for more than 2 days, do not restart Versacloz at the same dosage. Instead, contact your physician for dosing instructions.
• Do not drink alcohol while taking Versacloz. It can increase your chances of getting serious side effects.
• Do not drive, operate machinery, swim, climb, or do other dangerous activities until you know how Versacloz affects you.

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

During your first 6 months of Versacloz treatment, you will have weekly blood tests. If you have not taken clozapine before, you will need weekly blood tests when you first start Versacloz. If you have acceptable blood test results during your first 6 months of clozapine 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.

• Versacloz oral suspension bottle
• a bottle neck adaptor
• the correct oral syringe to measure your dose
  • If your dose is 1 mL (50 mg) or less, use the smaller 1 mL oral syringe.
  • If your dose is more than 1 mL (50 mg), use the larger 9 mL oral syringe.

How to take Versacloz:

• Make sure the cap is tight on the Versacloz bottle by turning the cap clockwise. Shake the bottle up and down for 10 seconds before use.
• Remove the bottle cap by pushing down on the cap and then turning it counterclockwise.
• The first time you open a new bottle, push the adapter into the bottle until the top of the adaptor is lined up with the top of the bottle. 
• Select the correct oral dose of your Versacloz as your pharmacist showed you.
  • If your dose is 1 mL (50 mg) or less, use the smaller 1 mL oral syringe.
  • If your dose is more than 1 mL (50 mg), use the larger 9 mL oral syringe.
• Fill the oral syringe with air by drawing back the plunger. 
• Insert the open tip of the oral syringe into the bottle neck adaptor. Push all the air from the oral syringe into the bottle by pushing down on the plunger. 
• While holding the oral syringe in place, carefully turn the bottle upside down. Draw some of the medicine out of the bottle into the oral syringe by pulling back on the plunger. Be careful not to pull the plunger all the way out.
• You will see a small amount of air near the end of the plunger in the oral syringe. Push on the plunger so the medicine goes back into the bottle and the air disappears. 
• Pull back on the plunger to draw your correct dose of medicine into the oral syringe.
• While still holding the oral syringe in the bottle, carefully turn the bottle upwards so the syringe is on top. Remove the oral syringe from the bottle neck adaptor without pushing on the plunger. 
• Take your medicine as soon as you draw it into the oral syringe. Do not store the medicine in the oral syringe for later use. 
• Put the open tip of the oral syringe into 1 side of your mouth. Close your lips around the oral syringe as tightly as you can. Push on the plunger slowly so the liquid goes into your mouth. Swallow the medicine slowly as it goes into your mouth.
• Leave the bottle neck adaptor in the bottle. Put the cap back on the bottle and turn it clockwise to tighten it. 
• Rinse the oral syringe with warm tap water after each use. Fill a cup with water. Put the tip of the oral syringe into the water in the cup, pull back on the plunger and draw the water into the oral syringe. Push on the plunger to squirt the water into the sink or a separate container. Repeat until the oral syringe is clean. 
• Let the oral syringe air dry. Throw away any leftover rinse water. 

How to dispose of Versacloz bottle and supplies:

• Place the cap back on the empty Versacloz bottle before you throw it away. The oral syringe, empty bottle and bottle neck adaptor should be placed in your household trash when you finish your bottle of Versacloz. The oral syringe should not be shared with other people or used for medicines other than Versacloz.

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

The recommended starting dose of Versacloz 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 Versacloz, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store Versacloz at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not refrigerate or freeze Versacloz.
• Protect Versacloz from light.
• Shake your Versacloz bottle well for 10 seconds before each use.
• Keep this and all other medications out of the reach of children

Versacloz 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 Versacloz 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.

Versacloz 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 Versacloz, because if you suddenly lose consciousness, you could harm yourself or others.

Versacloz 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.

Versacloz 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 Versacloz 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 Versacloz for 2 days or longer. Your doctor will probably tell you to restart your treatment with a low dose of Versacloz.

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 Versacloz have an increased chance of death during treatment.

Versacloz 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 Versacloz if you, a family member, or someone you care for has dementia and is taking this medication.