Lumateperone (loo-ma-TE-per-one)

Treats schizophrenia or bipolar depression.

Brand Name(s):

Caplyta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how lumateperone works. Tell your doctor if you are also using any of the following:
  • Amprenavir, aprepitant, armodafinil, bosentan, carbamazepine, ciprofloxacin, clarithromycin, cyclosporine, diltiazem, efavirenz, erythromycin, etravirine, fluconazole, fluvoxamine, itraconazole, modafinil, nafcillin, nefazodone, nelfinavir, phenytoin, pioglitazone, prednisone, probenecid, rifampin, ritonavir, St John's wort, valproic acid, verapamil, voriconazole
  • Blood pressure medicines
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• 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.
• Tell your doctor if you are breastfeeding or planning to breastfeed, or if you have kidney disease, liver disease, diabetes, trouble swallowing, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low blood pressure, heart failure, high cholesterol or fats in the blood, heart rhythm problems, or a history of a heart attack or stroke.
• 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 cause the following problems:
  • Increased risk of stroke
  • Neuroleptic malignant syndrome (a nerve and muscle problem)
  • Tardive dyskinesia (a muscle problem that may become permanent)
  • Changes in blood sugar or cholesterol levels
• This medicine may make you dizzy or drowsy, or may cause 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.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• This medicine may make it more difficult for your body to cool down. Be careful to not become overheated during exercise or hot weather, because you could have heat stroke.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, fast, slow, pounding, or uneven heartbeat
• Double vision, headache, trouble speaking, thinking, or walking
• Extreme energy, mood or mental changes, anxiety, agitation, restlessness, trouble sleeping, unusual thoughts or behavior
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Increased thirst, hunger, or urination
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Seizures
• Sweating, confusion, muscle stiffness
• Trouble breathing or swallowing

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Nausea
• Sleepiness or unusual drowsiness, tiredness
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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