Pronunciation:

loo-RAS-i-done

Brand Names:

• Latuda

Dosage Forms:

• Tablet

Warnings:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone is not approved for the treatment of patients with dementia-related psychosis. An increased risk of suicidal thoughts and behavior was found in pediatric and young adult patients taking antidepressants. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors .

Classifications:

Therapeutic—

Antipsychotic

Uses of This Medicine:

Lurasidone is used to treat symptoms of psychotic (mental) disorders, such as schizophrenia. This medicine should not be used to treat behavioral problems in elderly patients who have dementia. It may be used alone or with other medicines (eg, lithium, valproate) to treat depression caused by bipolar disorder.

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 lurasidone to treat schizophrenia in children younger than 13 years of age and to treat depression in children younger than 10 years of age. Safety and efficacy have not been established in these age groups.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lurasidone in the elderly. However, this medicine should not be used for behavioral problems in older adults with dementia.

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.

• Atazanavir
• Boceprevir
• Bromopride
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Darunavir
• Enzalutamide
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Metoclopramide
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Phenytoin
• Posaconazole
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

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
• Adagrasib
• Amprenavir
• Aprepitant
• Bosentan
• Buprenorphine
• Ceritinib
• Ciprofloxacin
• Crizotinib
• Dabrafenib
• Delavirdine
• Dexamethasone
• Diltiazem
• Duvelisib
• Efavirenz
• Erythromycin
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Imatinib
• Ivosidenib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Letermovir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Methadone
• Modafinil
• Nafcillin
• Netupitant
• Nevirapine
• Olutasidenib
• Omaveloxolone
• Oxcarbazepine
• Pacritinib
• Phenobarbital
• Pirtobrutinib
• Prednisone
• Primidone
• Ritlecitinib
• Trofinetide
• Verapamil

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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 dementia or
• Dehydration or
• Heart attack, history of or
• Heart failure or
• Heart or blood vessel disease or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Parkinson's disease or
• Stroke, history of or
• Trouble swallowing—May cause side effects to become worse.

• Blood or bone marrow problems (eg, agranulocytosis, leukopenia, neutropenia) or
• Diabetes or risk factors for diabetes or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin in the blood) or
• Mania, or history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe or
• Liver disease, moderate to severe—You may need a dose adjustment. Talk with your doctor if you have concerns about this.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor even if you feel well. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You must take this medicine with food (containing at least 350 calories).

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

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 schizophrenia:
    • Adults—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 160 mg per day.
    • Children 13 to 17 years of age—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For depression:
    • Adults—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
    • Children 10 to 17 years of age—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day.
    • Children younger than 10 years of age—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.

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 that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Lurasidone should not be used with certain medicines such as carbamazepine (Tegretol®), clarithromycin (Biaxin®), ketoconazole (Nizoral®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), St. John's wort, or voriconazole (Vfend®). Using these medicines together may cause serious unwanted effects. Make sure your doctor knows all of the medicines you are taking.

Lurasidone 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. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may increase risk of transient ischemic attack or stroke in elderly patients. Tell your doctor right away if you have confusion, double vision, headache, inability to move the arms, legs, or facial muscles, slow speech, or trouble speaking, thinking, or walking while using this medicine.

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 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 while you are using this medicine.

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. Talk to your doctor about ways to prevent weight gain.

Lurasidone 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 right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.

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

This medicine may cause some people to become drowsy or dizzy, or to have trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Avoid activities involving high temperature or humidity. This medicine may reduce your body's ability to adjust to the heat.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by 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

Absence of or decrease in body movement

difficulty with swallowing

drooling

inability to sit still

incremental or ratchet-like movement of the muscle

loss of balance control

mask-like face

muscle discomfort

muscle trembling, jerking, or stiffness

need to keep moving

restlessness

rigid or stiff muscles

shakiness in the legs, arms, hands, or feet

shuffling walk

slow movements

slow reflexes

slurred speech

stiffness of the arms and legs

tic-like (jerky) movements of the head, face, mouth, and neck

trembling or shaking of the hands or feet

twisting movements of the body

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

Less common

Arm, back, or jaw pain

blurred vision

burning while urinating

changes in patterns and rhythms of speech

chest pain or discomfort

chills

cold sweats

confusion

difficult or painful urination

difficulty opening the mouth

difficulty with breathing

dizziness

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

fast, pounding, or irregular heartbeat or pulse

fixed position of the eye

headache

high fever

inability to move the eyes

inability to speak

increased blinking or spasms of the eyelid

increased sweating

lockjaw

loss of bladder control

muscle spasm, especially of the neck and back

nervousness

pale skin

pounding in the ears

seizures

severe muscle stiffness

severe or sudden headache

slow or fast heartbeat

slurred speech

sticking out of the tongue

sweating

temporary blindness

tiredness

trouble with breathing, speaking, or swallowing

troubled breathing with exertion

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

unusual bleeding or bruising

unusual facial expressions

unusual tiredness or weakness

unusually pale skin

weakness in the arm or leg on one side of the body, sudden and severe

Rare

Black, tarry stools

bloody urine

breast pain or swelling

cough

dark-colored urine

decreased frequency or amount of urine

fever

increased thirst

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

lower back or side pain

muscle cramp, pain, or stiffness

nausea

sore throat

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

swelling of the face, fingers, or lower legs

swollen glands

vomiting

weight gain

Incidence not known

Decreased urine output

hives or welts, itching, skin rash

loss of consciousness

redness of the skin

swelling of the throat or tongue

tightness in the chest

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

Anxiety

belching

drowsiness

dry mouth

heartburn

hyperventilation

indigestion

irritability

relaxed and calm feeling

sleepiness or unusual drowsiness

stomach discomfort, upset, or pain

trouble sleeping

unusually deep sleep

unusually long duration of sleep

Less common

Abnormal dreams

back pain

blurred vision

burning feeling in the chest or stomach

decreased appetite

diarrhea

feeling of constant movement of self or surroundings

indigestion

sensation of spinning

sweating

tenderness in the stomach area

watering of mouth and drooling

Rare

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

unexpected or excess milk flow from the breasts

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.