Caplyta (lumateperone) is used in adults 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).

Caplyta is also used alone or with lithium or valproate to treat depression associated with bipolar disorder (manic depression).

Caplyta belongs to a class of medications called atypical antipsychotics. The exact way lumateperone works is unknown but it is thought to change the activity of certain natural substances in the brain.

Caplyta is not approved for use in older adults with dementia-related psychosis. Caplyta can increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Take Caplyta as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

The recommended dose is one Caplyta 42mg capsule taken once a day with or without food.

Your treatment may also include weight control, and frequent medical tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Schizophrenia:

42 mg orally once a day

Use: For the treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder:

42 mg orally once a day

Use: As monotherapy or as adjunctive therapy with lithium or valproate, for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression)

You should not use Caplyta if you are allergic to lumateperone.

Lumateperone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Caplyta is safe for you, tell your doctor if you have ever had:

• heart problems or a stroke;

• high or low blood pressure;

• seizures;

• trouble swallowing;

• low white blood cell count;

• high cholesterol or triglycerides;

• diabetes or high blood sugar, or a family history of diabetes or high blood sugar; or

• liver or kidney disease.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lumateperone on the baby.

You should not breastfeed while using Caplyta.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction ro Caplyta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

High doses or long-term use of Caplyta can cause a serious movement disorder that may not be reversible. The longer you use Caplyta, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Caplyta may cause serious side effects. Call your doctor at once if you have:

• feeling unsteady, feeling like you might pass out;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• tightness in your neck or throat, trouble swallowing;

• trouble breathing or speaking;

• a seizure;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Caplyta side effects may include:

• nausea;

• dizziness;

• drowsiness; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with lumateperone, especially:

• an antibiotic, antifungal, or antiviral medicine;

• blood pressure medication;

• bronchodilator asthma medication;

• cold or allergy medicine (Benadryl and others);

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• medicine to treat overactive bladder;

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• seizure medicine; or

• St. John's wort.

This list is not complete and many other drugs may interact with lumateperone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.