Lumateperone

IMPORTANT WARNING:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as lumateperone have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to lumateperone.

WHY is this medicine prescribed?

Lumateperone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Lumateperone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Lumateperone comes as a capsule to take by mouth. It is usually taken with food once daily. Take lumateperone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking lumateperone,

• tell your doctor and pharmacist if you are allergic to lumateperone, any other medications, or any of the ingredients in lumateperone capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole, and voriconazole (Vfend); antihistamines; medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems; aprepitant (Emend); armodafinil (Nuvigil); bosentan (Tracleer); calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac) and verapamil (Calan, Covera, Verelan); ciprofloxacin (Cipro); clarithromycin; cyclosporine (Neoral, Sandimmune); erythromycin (Eryc); fluvoxamine (Luvox); medications for HIV or AIDS such as amprenavir (Agenerase) (not commercially available in the US), efavirenz (Sustiva), etravirine (Intelence), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); modafinil (Provigil); nafcillin; nefazodone; pioglitazone (Actos); prednisone (Rayos); probenecid (Probalan); rifampin (Rifadin, Rimactane); sedatives; medications for seizures such as carbamazepine (Tegretol), phenytoin (Dilantin, Phenytek), and valproic acid; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lumateperone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• 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, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking lumateperone, call your doctor. Lumateperone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

• tell your doctor if you are breast-feeding. You should not breastfeed while taking lumateperone.

• 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 alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while 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 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.