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Lumateperone (By mouth)

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

Treats schizophrenia.

Brand Name(s):

Caplyta

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to lumateperone.

How to Use This Medicine:

Capsule

  • Your doctor will tell you how much medicine to use. Do not use more than directed.
  • It is best to take this medicine with food or milk.
  • 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 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, or 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 during treatment with this medicine. This medicine may cause extrapyramidal or withdrawal symptoms (including agitation, feeding disorder, tremor, unusual drowsiness) in the baby during the third trimester.
  • Do not breastfeed during treatment with this medicine.
  • Tell your doctor 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, a low amount of blood, heart rhythm problems, or a history of a heart attack or stroke.
  • This medicine may cause the following problems:
    • Increased risk of stroke
    • Neuroleptic malignant syndrome (NMS)
    • Tardive dyskinesia (a movement disorder)
    • Changes in blood sugar levels
  • 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 you dizzy or drowsy, 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.
  • This medicine 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.
  • 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
  • Confusion, double vision, headache, trouble speaking, thinking, or walking
  • Fever, chills, cough, runny or stuffy nose, sore throat, body aches
  • Increased thirst, hunger, or urination
  • Lightheadedness, dizziness, or fainting
  • Neck muscle spasm, throat tightness, trouble swallowing or breathing, or sticking out of the tongue
  • Seizures
  • Sweating, muscle stiffness
  • Twitching or muscle movements you cannot control (often in your face, tongue, or jaw)

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


Last Updated: 5/1/2020

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