Pronunciation:

loo-ma-TE-per-one

Brand Names:

• Caplyta

Dosage Forms:

• Capsule

Warnings:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lumateperone is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of lumateperone have not been established in pediatric patients .

Classifications:

Therapeutic—

Antipsychotic

Uses of This Medicine:

Lumateperone is used to treat schizophrenia. It is also used alone or with other medicines (eg, lithium or valproate) to treat depressive episodes in patients with bipolar I or II disorder (bipolar depression). This medicine should not be used to treat behavioral problems in elderly 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 lumateperone in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

• Abametapir
• Apalutamide
• Aprepitant
• Armodafinil
• Atazanavir
• Boceprevir
• Bosentan
• Carbamazepine
• Cenobamate
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Dexamethasone
• Diltiazem
• Dronedarone
• Efavirenz
• Enzalutamide
• Erythromycin
• Eslicarbazepine Acetate
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fluvoxamine
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ketoconazole
• Letermovir
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nilotinib
• Omaveloxolone
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Posaconazole
• Prednisone
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Verapamil
• Voriconazole

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
• Neuroleptic malignant syndrome, history of or
• Stroke, history of or
• Trouble swallowing—May cause side effects to become worse.

• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Hyperglycemia (high blood sugar) or
• Seizures, history of—Use with caution. May make these conditions worse.

• 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. Do not take more of this medicine and do not take it more often than your doctor ordered.

You may take this medicine with or without food.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

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 (capsules):
  • For schizophrenia and bipolar depression:
    • Adults—42 milligrams (mg) once a 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.

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.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects to newborn babies if used during the later part of pregnancy.

For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.

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

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.

Lumateperone 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 this problem continues or gets worse, check with your doctor.

This medicine may cause some people to become may cause drowsiness, trouble with thinking or controlling body movements, 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.

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.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

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 (eg, St. John's wort) 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:

Incidence not known

Black, tarry stools

blurred vision

chest pain

confusion

cough or hoarseness

double vision

dry mouth

fast heartbeat

fever with or without chills

flushed, dry skin

fruit-like breath odor

general feeling of tiredness or weakness

headache

high fever

inability to move the arms, legs, or facial muscles

inability to move the eyes

inability to speak

increased blinking or spasms of the eyelid

increased hunger

increased sweating

increased thirst

increased urination

lip smacking or puckering

loss of bladder control

lower back or side pain

nausea

numbness or tingling in the face, arms, or legs

painful or difficult urination

puffing of the cheeks

rapid or worm-like movements of the tongue

seizures

severe muscle stiffness

slow speech

sore throat

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

sticking out of the tongue

stomach pain

sweating

swollen glands

tiredness

trouble in breathing, speaking, or swallowing

trouble thinking or walking

uncontrolled chewing movements

uncontrolled movements of the arms and legs

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

unexplained weight loss

unusual bleeding or bruising

unusual facial expressions

unusual tiredness or weakness

unusually pale skin

vomiting

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

Dizziness

dry mouth

sleepiness or unusual drowsiness

weight gain

Incidence not known

Burning feeling

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.