Fanapt

Fanapt is used to treat schizophrenia in adults or acute manic or mixed episodes associated with bipolar I disorder in adults. It is taken orally (by mouth) twice a day.

Fanapt (iloperidone) is an atypical antipsychotic that is thought to work by blocking two key brain receptors, dopamine (D2) and serotonin (5-HT2), which help regulate mood and perception, although the exact way it works is not known.

Fanapt was proven effective for schizophrenia across three clinical trials, significantly outperforming placebo in reducing symptoms. In bipolar I disorder, a 4-week trial showed Fanapt 24 mg/day substantially reduced manic symptoms compared to placebo, with benefits seen across age, sex, and race.

Fanapt (iloperidone) gained FDA approval on May 6, 2009. A generic is available under the name iloperidone.

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.

• Fanapt is taken twice a day.
• Your healthcare provider will start with a low dose and slowly increase it to the recommended therapeutic dose. This is to reduce the risk of orthostatic hypotension (feeling dizzy when you go from a stiing or lying down to standing position).
• Fanapt may be taken with or without food.

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 regularly.

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.

Fanapt carries a Boxed Warning for increased risk of death in elderly patients with dementia-related psychosis. Fanapt is not approved for dementia-related psychosis. Elderly patients with dementia-related psychosis who take antipsychotic medicines like Fanapt have a higher risk of death than those taking a placebo.

Other warnings and serious side effects include:

• Risk of allergic reactions: Patients should not use Fanapt if they have a known allergy to Fanapt or its ingredients. Allergic reactions, including anaphylaxis, rapid swelling of the skin (angioedema), throat tightness, swelling of the throat, face, lips, mouth, and tongue, hives, rash, and itching, have been reported. Tell your healthcare provider if you have any of these symptoms
• Stroke risk: An increased risk of stroke has been reported in elderly people with dementia-related psychosis. Fanapt is not approved for use in people with dementia-related psychosis.
• Heart rhythm changes: Fanapt may alter your heart rhythm. Tell your healthcare provider if you have or have had heart problems. Contact them right away if you feel faint or notice irregular or forceful heartbeats, as these could be signs of a rare but potentially fatal side effect. Do not use Fanapt with other drugs known to cause heart rhythm changes.
• Neuroleptic malignant syndrome (NMS): Tell your healthcare provider immediately if you experience very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of NMS, a rare but serious and potentially fatal condition.
• Tardive dyskinesia (TD): Abnormal or uncontrollable movements of the face, tongue, or other parts of the body may be signs of TD, which could become permanent. The risk of TD becoming permanent increases the longer you take the medication and the higher your dose. Tell your healthcare provider if you experience uncontrollable body movements.
• Metabolic changes: Fanapt has been associated with high blood sugar, high cholesterol, high triglycerides, and weight gain, all of which can increase cardiovascular risk. In some cases, high blood sugar has been linked to coma or death. Your healthcare provider should monitor your blood sugar, fat levels, and weight before and regularly during treatment.
• Liver problems: Tell your healthcare provider about any liver conditions. Fanapt is not recommended for patients with severe liver problems.
• Seizures: Tell your healthcare provider if you have a history of seizures or any condition that may increase your seizure risk before starting Fanapt.
• Orthostatic hypotension and falls: Light-headedness or faintness when rising quickly from a sitting or lying position has been reported, particularly when starting treatment, restarting treatment, or increasing the dose. Fanapt may also increase the risk of falls, which could cause fractures or other injuries.
• Low white blood cell count: Decreases in infection-fighting white blood cells have been reported in some patients taking antipsychotics. If you have a history of low white blood cell counts, your blood should be monitored during the first few months of therapy. Rare but serious cases of agranulocytosis have been reported with drugs like Fanapt.
• Elevated prolactin levels: Fanapt can raise prolactin levels. Tell your healthcare provider if you experience breast enlargement, breast pain, breast discharge, irregular menstrual cycles, or impotence. Persistently elevated prolactin levels may lead to bone loss.
• Overheating and dehydration: Fanapt may affect your body's ability to regulate temperature. Avoid overheating and dehydration.
• Swallowing problems: Fanapt has been associated with difficulty swallowing (dysphagia). Tell your healthcare provider if you have or have had swallowing problems.
• Priapism: In the rare event of a painful or prolonged erection lasting 4 or more hours, stop taking Fanapt and seek immediate medical attention.
• Impaired judgment and motor skills: Fanapt can affect your judgment, thinking, and motor skills. Do not drive or operate hazardous machinery until you know how Fanapt affects you.
• Eye surgery: A condition called intraoperative floppy iris syndrome has been observed in some patients taking drugs like Fanapt. Tell your eye surgeon if you take or have taken Fanapt before cataract or other eye surgery.

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.

Fanapt and medicines like it have been associated with swallowing problems (dysphagia). If you have or have had swallowing problems, you should tell your healthcare provider.

When taking Fanapt, you should avoid drinking alcohol, and you should not breastfeed.

You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking Fanapt.

Tell your healthcare provider about all prescription and non-prescription medicines and supplements you are taking. Some medications may interact with Fanapt.

Fanapt is not FDA-approved for use in children or adolescents <18 years.

If you experience a side effect while taking Fanapt, you are encouraged to report it. Contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The exact way Fanapt works in schizophrenia and bipolar I disorder is not fully understood. It is believed to work by blocking two key receptors in the brain, dopamine (D2) and serotonin (5-HT2). These receptors play an important role in regulating mood, thoughts, and perception, and when overactive, can contribute to symptoms such as hallucinations and mood disturbances.

When the body processes Fanapt, it also produces an active metabolite called P88, which works in a similar way to the drug itself and may contribute to its overall effect.

Fanapt (iloperidone) belongs to the drug class called atypical antipsychotics.

Do not use Fanapt if you have a known allergy to Fanapt, iloperidone, or its ingredients (see the end of this guide for a list of ingredients).

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

Before taking Fanapt, tell your healthcare provider about all your medical conditions, including if you have:

• Problems with your liver. Fanapt is not recommended for patients with severe liver problems.
• 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.
• Plans to become pregnant or are pregnant
• Plans to breastfeed or are breastfeeding.

Pregnancy

Taking Fanapt in the third trimester of pregnancy may cause extrapyramidal and/or withdrawal symptoms in a neonate. You should tell your healthcare provider immediately if you become pregnant.

Pregnancy Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Fanapt during pregnancy

Breastfeeding

Do not breastfeed while taking Fanapt.

The most common side effects of Fanapt in patients with schizophrenia were dizziness, dry mouth, feeling unusually tired or sleepy, stuffy nose, feeling faint/light-headed when standing quickly, racing heartbeat, and weight gain.

The most common side effects of Fanapt in patients with bipolar I disorder were racing heartbeat, dizziness, dry mouth, increased liver enzymes, stuffy nose, weight gain, low blood pressure, and feeling unusually tired or sleepy.

Compared to placebo, the average weight gain in clinical studies in schizophrenia lasting 4 to 6 weeks was 6 pounds, and in a clinical study of patients with bipolar I disorder over 4 weeks was 7 pounds.

If you experience any of these symptoms, talk with your healthcare provider.

Dose of Fanapt for Schizophrenia

• Starting dose: 1 mg orally twice daily
• Titration: Titrate over 7 days according to the titration schedule in the prescribing information to avoid orthostatic hypotension.
• Recommended Maintenance Dose: 6 mg to 12 mg twice daily

Dose of Fanapt for Acute Manic or Mixed Episodes Associated with Bipolar I Disorder

• Starting dose: 1 mg orally twice daily
• Titration: Titrate over 5 days according to the titration schedule in the prescribing information to avoid orthostatic hypotension.
• Recommended Maintenance Dose: 12 mg twice daily

Recommended Dosage Adjustments

• Liver Disease: Consider a reduced dose for moderate impairment. Not recommended for severe liver impairment.
• Known CYP2D6 Poor Metabolizers: Reduce the dose of Fanapt by half.
• Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inhibitors: Dosage modifications recommended see Fanapt prescribing information.

Avoid alcohol while taking Fanapt.

Do not breastfeed while taking Fanapt.

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.

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Especially tell your doctor if you take:

• Strong CYP2D6 inhibitors (such as fluoxetine, paroxetine). Your dosage of Fanapt may need to be halved.
• Strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin). Your dosage of Fanapt may need to be halved.
• Inhibitors of CYP2D6 and CYP3A4. Your dosage of Fanapt may need to be halved.

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.

Store at room temperature, protect from light and moisture.

Fanapt tablets are manufactured by Vanda Pharmaceuticals Inc., Washington, D.C. 20037 USA.

Active ingredient: iloperidone

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and purified water (removed during processing).

Fanapt tablets are available in the following strengths: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg.