Description and Brand Names

US Brand Name

1. Fanapt
2. Fanapt Titration Pack

Descriptions

Iloperidone is used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with bipolar disorder (manic-depressive illness). This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of iloperidone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iloperidone in the elderly. However, elderly patients are more likely to have dementia, which may require caution in patients receiving iloperidone.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mavorixafor
• Mesoridazine
• Metoclopramide
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acecainide
• Adagrasib
• Ajmaline
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Boceprevir
• Bretylium
• Bunazosin
• Buprenorphine
• Bupropion
• Buserelin
• Celecoxib
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dapiprazole
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxazosin
• Doxepin
• Droperidol
• Duloxetine
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Givinostat
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomethadyl
• Lofexidine
• Lonafarnib
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Moxisylyte
• Nafarelin
• Nefazodone
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenoxybenzamine
• Phentolamine
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Prazosin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Silodosin
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tamsulosin
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Terazosin
• Tetrabenazine
• Tolazoline
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimazosin
• Trimipramine
• Triptorelin
• Troleandomycin
• Tucatinib
• Urapidil
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alzheimer’s disease or
• Blood vessel disease or
• Bradycardia (slow heartbeat), severe or
• Dehydration or
• Heart attack, recent or history of, or
• Heart failure, history of or
• Heart rhythm problems (eg, prolonged QT interval), or a history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Stroke, history of—May cause side effects to become worse.

• Blood or bone marrow problems (eg, leukopenia, neutropenia) or
• Breast cancer, prolactin-dependent or
• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin in the blood) or
• Neuroleptic malignant syndrome (NMS), history of or
• Priapism (painful and prolonged erection of the penis) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Cataract surgery—An eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in patients who are taking or who have recently taken this medicine when they are having cataract surgery. You should tell your ophthalmologist (eye doctor) before your surgery if you are taking iloperidone.

• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Should not use in patients with this condition.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of schizophrenia and manic or mixed episodes with bipolar disorder:
    • Adults—At first, 1 milligram (mg) 2 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 12 mg 2 times a day (24 mg per day).
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor for instructions if you must stop taking the medicine for more than 3 days.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

This medicine can cause a change in heart rhythm called QT prolongation. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or trouble breathing. Call your doctor right away if you have any of these symptoms or any questions.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase prolactin levels in the body if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you medicines that can lower these.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Iloperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

This medicine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, which may lead to falls, fractures, or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Avoid drinking alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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