Pronunciation:

eye-loe-PER-i-done

Brand Names:

• Fanapt
• Fanapt Titration Pack

Dosage Forms:

• Tablet

Warnings:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Iloperidone is not approved for use in patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Benzisoxazole

Uses of This Medicine:

Iloperidone is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. 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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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 or age-related liver problems, which may require caution in patients receiving iloperidone.

Breast-feeding—

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.

Other medicines—

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
• 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
• Azimilide
• Azithromycin
• Bedaquiline
• Bretylium
• Buprenorphine
• Buserelin
• Celecoxib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Duloxetine
• Efavirenz
• Encorafenib
• Entrectinib
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nefazodone
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Ritonavir
• Selpercatinib
• Sematilide
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• 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 or
• Breast cancer, prolactin-dependent or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin in the blood) or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• 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 of This Medicine:

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:
    • Adults—At first, 1 milligram (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 12 mg two 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 While Using This Medicine:

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 changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, 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 any of the following symptoms while taking this medicine: 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 blood levels 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 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 itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone. If you become too cold, you may feel drowsy, confused, or clumsy.

Iloperidone may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast, pounding, or irregular heartbeat or pulse

Less common

Blurred vision

body aches or pain

chills

cold sweats

confusion

cough

difficult or labored breathing

difficulty with moving

difficulty with speaking

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drooling

ear congestion

fever

headache

inability to sit still

loss of balance control

loss of voice

muscle pain or stiffness

muscle trembling, jerking, or stiffness

nasal congestion

need to keep moving

pain in the joints

restlessness

runny nose

shakiness in the legs, arms, hands, or feet

shortness of breath

shuffling walk

sneezing

sore throat

stiffness of the limbs

sweating

tightness in the chest

trembling or shaking of the hands or feet

twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

uncontrolled movements, especially of the face, neck, and back

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Rare

Abdominal or stomach fullness

aching or discomfort in the lower legs or sensation of crawling in the legs

actions that are out of control

aggressive or angry

agitation

anxiety

attack, assault, or force

back pain

black, tarry stools

bloody nose

burning while urinating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

coma

confusion as to time, place, or person

constipation

convulsions

decrease in the amount of urine

decrease in the frequency of urination

decrease in urine volume

decreased awareness or responsiveness

decreased urination

decreased weight

depression

difficult or painful urination

difficulty in passing urine (dribbling)

difficulty with walking

dilated neck veins

dizziness

dry mouth

dry skin and hair

extreme thirst

extremely high fever or body temperature

fainting

false beliefs that cannot be changed by facts

fast, shallow breathing

feeling cold

frequent urination

gaseous abdominal pain

groin pain

hair loss

hoarseness or husky voice

holding false beliefs that cannot be changed by fact

hostility

inability to move the eyes

increased blinking or spasms of the eyelid

increased thirst

irregular breathing

irritability

lightheadedness

loss of appetite

loss of bladder control

mimicry of speech or movements

mood swings

muscle aching or cramping

muscle spasms

muscle twitching

nausea or vomiting

nervousness

noisy breathing

noisy, rattling breathing

numbness or tingling in the hands, feet, or lips

pale, clammy skin

peculiar postures or movements, mannerisms, or grimacing

pounding, slow heartbeat

rapid breathing

rapid weight gain

recurrent fever

restlessness

seizures

severe sleepiness

slow movement

slow reflexes

sore throat

sore tongue

sores, ulcers, or white spots on the lips or in the mouth

sticking out of tongue

stupor

sunken eyes

swelling

swelling of the face, ankles, fingers, feet, or lower legs

swollen glands

swollen joints

swollen, tender prostate

talking, feeling, and acting with excitement

thirst

troubled breathing at rest

troubled breathing with exertion

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual bleeding or bruising

unusual excitement, nervousness, or restlessness

unusual facial expressions

weight gain

wrinkled skin

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

sleepiness or unusual drowsiness

Less common

Abdominal or stomach discomfort

not able to ejaculate semen

rash

stuffy nose

Rare

Absent, missed, or irregular menstrual periods

blindness

blurred vision

breast pain

burning feeling in the chest or stomach

burning upper abdominal pain

canker sores

continuing ringing or buzzing or other unexplained noise in the ears

decreased interest in sexual intercourse

decreased vision

delusions of persecution, mistrust, suspiciousness, or combativeness

dry eyes

feeling of constant movement of self or surroundings

hearing loss

inability to have or keep an erection

increase in blood flow to the whites of the eyes

increased appetite

increased watering of the mouth

indigestion

irregular menstruation

irritation or soreness of the mouth

longer or heavier menstrual periods

loss in sexual ability, desire, drive, or performance

loss of bowel control

loss of memory

normal menstrual bleeding occurring earlier, possibly lasting longer than expected

problems with memory

redness, swelling, or itching of the eyelids

sensation of spinning

stomach upset

stopping of menstrual bleeding

swelling of the breasts or breast soreness in both females and males

swelling or inflammation of the mouth

tenderness in the stomach area

uncontrolled eye movements

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.