Lumateperone

Important warning for older adults with dementia:

Older adults with dementia (loss of memory and brain function) may have an increased chance of death if treated with antipsychotic medications such as lumateperone. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment with antipsychotics.

Important warning for people who have depression:

Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses have a greater risk of becoming suicidal. This is especially of concern at the beginning of treatment and any time that your dose is changed. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and mania (frenzied, abnormally excited mood). Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of taking lumateperone.

Lumateperone is used to treat: Lumateperone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

• schizophrenia (a mental illness that affects how a person thinks, feels and behaves)
• bipolar I disorder (a disease that causes depression, mania, and other abnormal moods)
• major depressive disorder

Lumateperone comes as a capsule to take by mouth. Take with food once daily. Take lumateperone at around the same time every day.

Take lumateperone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lumateperone may help control your symptoms, but it will not cure your condition. It may take several weeks or longer before you feel the full benefit of lumateperone. Continue to take lumateperone even if you feel well. Do not stop taking lumateperone without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lumateperone,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with lumateperone. Make sure you have discussed any medications you are currently taking or plan to take before starting lumateperone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking lumateperone, please get the advice of your doctor or pharmacist.
• the following herbal product may interact with lumateperone: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking lumateperone. Do not start this medication while taking lumateperone without discussing with your healthcare provider.
• tell your doctor if you have severe diarrhea or vomiting or you think you may be dehydrated. Also, tell your doctor if you have or have ever had heart disease, heart failure, a heart attack, an irregular heartbeat, high or low blood pressure, a stroke, or a ministroke; any condition that makes it difficult for you to swallow; seizures; trouble keeping your balance; diabetes; a low number of white blood cells; dyslipidemia (high cholesterol levels); or liver disease.
• tell your doctor if you are pregnant, if you plan to become pregnant or are breast-feeding. If you become pregnant while taking lumateperone, call your doctor.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking lumateperone.
• you should know that lumateperone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking lumateperone.
• you should know that lumateperone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking lumateperone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that lumateperone may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to exercise or be exposed to extreme heat.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking lumateperone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking lumateperone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

Do not drink grapefruit juice or eat grapefruit while taking this medication.

Take the missed dose as soon as you remember it with food. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Lumateperone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• extreme tiredness or fatigue
• weight gain
• nausea
• dry mouth
• dizziness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or the SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• rash, hives, or itching
• problems with coordination or increased falls
• unusual movements of your face or body that you cannot control
• sore throat, fever, chills, or other signs of infection
• fever; stiff muscles; sweating; confusion; sweating; or fast, pounding, or irregular heartbeat
• tightening of neck muscles or throat; or difficulty breathing or swallowing
• seizures

Lumateperone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order laboratory tests before and during your treatment with lumateperone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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