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

Fanapt is used to treat schizophrenia in adults.

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

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

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 this medicine 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 may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• trouble swallowing;

• long QT syndrome (in you or a family member);

• a seizure;

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

• breast cancer;

• high cholesterol or triglycerides;

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

• low bone mineral density; or

• liver disease.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of iloperidone on the baby.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Fanapt without your doctor's advice.

You should not breastfeed while you are taking iloperidone.

Fanapt is not approved for use by anyone younger than 18 years old.

Take Fanapt exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

It may take at least 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 on a regular basis.

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.

Usual Adult Dose for Schizophrenia:

Initial dose: 1 mg orally twice a day
Maintenance dose: 6 to 12 mg twice a day
Maximum dose: 24 mg/day

Comments:
-This drug must be titrated slowly to avoid orthostatic hypotension.
-Control of symptoms may be delayed during the first 1 to 2 weeks of treatment because of the need to titrate slowly.
-Treatment should be increased in increments of not more than 2 mg twice daily as tolerated.
-Healthcare providers should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

Use: Treatment of schizophrenia

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

Fanapt may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• trouble swallowing;

• long QT syndrome (in you or a family member);

• a seizure;

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

• breast cancer;

• high cholesterol or triglycerides;

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

• low bone mineral density; or

• liver disease.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of iloperidone on the baby.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Fanapt without your doctor's advice.

You should not breastfeed while you are taking iloperidone.

Fanapt is not approved for use by anyone younger than 18 years old.

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.

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

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

While you are taking Fanapt, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have 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 Fanapt can cause a serious movement disorder that may not be reversible. The longer you use iloperidone, the more likely you are to develop this disorder, especially if you are an older adult.

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

• fast or pounding heartbeats, fluttering in your chest;

• a light-headed feeling, like you might pass out;

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

• tremors, slow muscle movement, muscles pain or stiffness;

• confusion, agitation, thoughts of hurting yourself;

• loss of bladder control;

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

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• low white blood cell counts - fever, chills, sore throat, mouth sores, skin sores, cough, trouble breathing; 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Iloperidone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Fanapt with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with iloperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.