Fanapt

Iloperidone comes as a tablet to take by mouth. It is usually taken with or without food twice a day. Take iloperidone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take iloperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of iloperidone and gradually increase your dose, not more often than once every day for the first 7 days. Your doctor will also need to start you on a low dose of iloperidone and gradually increase your dose if you do not take iloperidone for 3 days or longer at any time during your treatment.

Iloperidone may help control your symptoms but will not cure your condition. It may take up to 2 weeks or longer before iloperidone begins to control your symptoms. Continue to take iloperidone even if you feel well. Do not stop taking iloperidone without talking to your doctor.

Before taking iloperidone,

• tell your doctor and pharmacist if you have had a serious allergic reaction (difficulty breathing or swallowing or swelling of the face, lips, throat, tongue, hands, or feet) to iloperidone. Your doctor will probably tell you not to take iloperidone. Also tell your doctor if you are allergic to any other medications, or any of the ingredients in iloperidone tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antidepressants; antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); bupropion (Aplenzin, Wellbutrin, Zyban); chlorpromazine; clarithromycin (Biaxin); fluoxetine (Prozac, Sarafem); gatifloxacin (Tequin) (not available in the U.S.); certain HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); levo-alpha-acetylmethadol (ORLAAM) (not available in the U.S.); methadone (Dolophine, Methadose); medications for mental illness, high blood pressure, or seizures; moxifloxacin (Avelox); nefazodone; paroxetine (Paxil, Pexeva); pentamidine (Nebupent, Pentam); procainamide; quinidine; sedatives; sleeping pills; sotalol (Betapace); thioridazine or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you use or have ever used street drugs or have overused prescription medications, or have or have had thoughts about harming or killing yourself. Also tell your doctor if you or anyone in your family has or has ever had diabetes and if you have or have ever had prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), a slow or irregular heartbeat, a recent heart attack, heart failure, dyslipidemia (high cholesterol levels), a low level of potassium or magnesium in your blood, seizures, breast cancer, trouble keeping your balance, any condition that makes it difficult for you to swallow, or heart or liver disease. Also tell your doctor if you have a low level of white blood cells or if you have ever developed a low level of blood cells as a side effect of a medication that you took. Also tell your doctor if you have severe vomiting or diarrhea or become dehydrated at any time during your treatment.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking iloperidone, call your doctor. Iloperidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• you should know that iloperidone may affect your thinking, judgment, and ability to move. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking iloperidone. Alcohol can make the side effects from iloperidone worse.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking iloperidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking iloperidone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• you should know that iloperidone may cause dizziness, lightheadedness, fast heartbeat, and fainting when you get up too quickly from a lying position. This is more common when you first start taking iloperidone or when your dose is increased. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that taking iloperidone may make it harder for your body to cool down if it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.

Iloperidone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weight gain
• nausea
• diarrhea
• stomach pain
• dry mouth
• sleepiness
• breast enlargement or discharge
• missed menstrual periods
• decreased sexual ability in men
• joint pain
• dizziness, feeling unsteady, or having trouble keeping your balance

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
• hives
• itching
• swelling of the face, lips, throat, tongue, hands, or feet
• difficulty breathing or swallowing
• dizziness; fast, pounding, or irregular heartbeat; or fainting
• falling
• unusual movements of the face or body that you cannot control
• seizures
• sore throat, fever, chills, and other signs of infection
• unexplained fever without other signs of infection
• muscle stiffness
• confusion
• sweating
• painful erection that lasts for hours

Iloperidone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

• Novartis Pharmaceuticals Corporation

• Vanda Pharmaceuticals Inc.

Fanapt is part of the drug class:

• Other antipsychotics

Take Fanapt exactly as prescribed.

Fanapt  comes in tablet form and is taken twice a day, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Fanapt at the same time.

• Store Fanapt at room temperature 25°C (77°F).
• Protect Fanapt tablets from exposure to light and moisture.
• Keep this and all medicines out of the reach of children.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Iloperidone can be taken with or without food.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Your doctor will need to check your progress while you are using iloperidone.

If you have stopped taking iloperidone for more than 3 days in a row, talk with your doctor before you start taking it again. You may need to restart the medicine at a lower dose.

Store at room temperature away from moisture, heat, and light.

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 high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Dizziness or passing out.
• A heartbeat that does not feel normal.
• A fast heartbeat.
• Change in how you act.
• Mood changes.
• Shakiness, trouble moving around, or stiffness.
• Not able to pass urine or change in how much urine is passed.
• Trouble swallowing.
• Seizures.
• Shortness of breath.
• Enlarged breasts.
• Change in sex ability.
• Nipple discharge.
• For women, no period.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
• Some people who take this medicine may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if Fanapt is stopped. Sometimes, signs may lessen or go away over time after this medicine 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 Fanapt 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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach.
• Weight gain.
• Dry mouth.
• Feeling sleepy.
• Feeling tired or weak.
• Stuffy nose.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Fanapt® tablets are indicated for the treatment of adults with schizophrenia. Efficacy was established in two short-term (4- and 6-week) placebo-and active-controlled studies of adult patients with schizophrenia [see Clinical Studies (14)].

When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that Fanapt is associated with prolongation of the QTc interval [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether Fanapt will cause torsade de pointes or increase the rate of sudden death is not yet known.

Patients must be titrated to an effective dose of Fanapt. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia [see Dosage and Administration (2.1) and Clinical Studies (14)].

The effectiveness of Fanapt in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Fanapt for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].

     Human Experience

In pre-marketing trials involving over 3210 patients, accidental or intentional overdose of Fanapt was documented in 8 patients ranging from 48 mg to 576 mg taken at once and 292 mg taken over a 3-day period. No fatalities were reported from these cases. The largest confirmed single ingestion of Fanapt was 576 mg; no adverse physical effects were noted for this patient. The next largest confirmed ingestion of Fanapt was 438 mg over a 4-day period; extrapyramidal symptoms and a QTc interval of 507 msec were reported for this patient with no cardiac sequelae. This patient resumed Fanapt treatment for an additional 11 months. In general, reported signs and symptoms were those resulting from an exaggeration of the known pharmacological effects (e.g., drowsiness and sedation, tachycardia and hypotension) of Fanapt.

     Management of Overdose

There is no specific antidote for Fanapt. Therefore appropriate supportive measures should be instituted. In case of acute overdose, the physician should establish and maintain an airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizures or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous ECG monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide and quinidine should not be used, as they have the potential for QT-prolonging effects that might be additive to those of Fanapt. Similarly, it is reasonable to expect that the alpha-blocking properties of bretylium might be additive to those of Fanapt, resulting in problematic hypotension. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of Fanapt-induced alpha blockade). In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision should continue until the patient recovers.

Fanapt tablets are white, round and identified with a logo “” debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side. Tablets are supplied in the following strengths and package configurations:

Storage

Store Fanapt tablets at controlled room temperature, 25°C (77°F); excursions permitted to 15°to 30 °C (59° to 86°F) [See USP Controlled Room Temperature]. Protect Fanapt tablets from exposure to light and moisture.

Take Fanapt exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Fanapt can be taken with or without food.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Your doctor will need to check your progress while you are using Fanapt.

If you have stopped taking Fanapt for more than 3 days in a row, talk with your doctor before you start taking it again. You may need to restart the medicine at a lower dose.

Store at room temperature away from moisture, heat, and light.

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes