fanapt

Fanapt (iloperidone) is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Fanapt is used to treat schizophrenia.

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

Important information

Fanapt is not approved for use in psychotic conditions related to dementia. Iloperidone may increase the risk of death in older adults with dementia-related conditions.

While you are taking Fanapt, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Fanapt may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It can increase some of the side effects of this medicine. Stop using this medicine and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, or feeling like you might pass out.

If you have stopped taking Fanapt for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose.

Before taking this medicine

You should not use Fanapt if you are allergic to iloperidone.

Fanapt is not approved for use in psychotic conditions related to dementia. Iloperidone may increase the risk of death in older adults with dementia-related conditions.

To make sure Fanapt is safe for you, tell your doctor if you have:

• heart disease or high blood pressure;

• a personal or family history of Long QT syndrome;

• a history of heart attack or stroke (including "mini-stroke");

• seizures or epilepsy;

• diabetes (iloperidone may raise your blood sugar);

• kidney or liver disease;

• a history of breast cancer;

• high cholesterol or triglycerides;

• a history of low white blood cell (WBC) counts;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• diabetes, or risk factors such as being overweight or having a family history of diabetes;

• a history of suicidal thoughts;

• trouble swallowing; or

• if you are malnourished or dehydrated.

FDA pregnancy category C. It is not known whether Fanapt will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

See also: Pregnancy and breastfeeding warnings (in more detail)

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Fanapt, do not stop taking it without your doctor"s advice.

It is not known whether iloperidone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Fanapt.

How should I take Fanapt?

Take Fanapt exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Fanapt can be taken with or without food.

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

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.

Fanapt dosing information

Usual Adult Dose for Psychosis:

Fanapt must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alpha-adrenergic blocking properties.

Recommended starting dose: 1 mg twice daily.

Increases to reach the target dose range of 6 to 12 mg twice daily may be made with daily dosage adjustments to 2 mg twice daily, 4 mg twice daily, 6 mg twice daily, 8 mg twice daily, 10 mg twice daily, and 12 mg twice daily on days 2, 3, 4, 5, 6, and 7, respectively.

Efficacy has been demonstrated in a dose range of 6 to 12 mg twice daily.

The maximum recommended dose is 12 mg twice daily (24 mg/day). Doses above 24 mg/day have not been systematically evaluated in the clinical trials.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Fanapt?

While you are taking Fanapt, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Fanapt.

Fanapt may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of Fanapt.

Fanapt side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Fanapt: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of iloperidone can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Fanapt, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough;

• little or no urinating;

• penis erection that is painful or lasts 4 hours or longer; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Older adults may be more likely to have side effects from this medicine.

Common Fanapt side effects may include:

• weight gain;

• dizziness, drowsiness, tired feeling;

• dry mouth, stuffy nose; or

• fast heart rate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Fanapt?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Fanapt with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Fanapt, especially:

• droperidol;

• methadone;

• an antibiotic - azithromycin, ciprofloxacin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, pentamidine;

• antifungal medicine - fluconazole, ketoconazole, posaconazole, voriconazole;

• cancer medicine - arsenic trioxide, vandetanib, vemurafenib;

• an antidepressant - amitriptylline, amoxapine, citalopram, clomipramine, desipramine, escitalopram, fluoxetine, imipramine;

• anti-malaria medication - chloroquine, lumefantrine;

• heart rhythm medicine - amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, quinidine, sotalol; or

• medicine to treat a psychiatric disorder - chlorpromazine, haloperidol, paliperidone, pimozide, ziprasidone, others.

This list is not complete. Other drugs may interact with iloperidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.