Pronunciation: kap-LITE-ah
Generic name: lumateperone
Dosage form: oral capsule
Drug class: Atypical antipsychotics

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 10, 2024.

What is Caplyta?

Caplyta (lumateperone) is used to treat adults with schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) or depression associated with bipolar 1 or 2 disorder (manic depression).

• When used to treat bipolar disorder, Caplyta can be used alone or with lithium or valproate.

Caplyta's mechanism of action involves changing the activity of neurotransmitters in the brain, such as dopamine, glutamate, and serotonin to increase or balance their levels. Caplyta helps relieve symptoms such as hallucinations, delusions, and disorganized thoughts associated with schizophrenia, and low mood associated with bipolar depression. See What is the mechanism of action for Caplyta? for more information.

Caplyta gained FDA approval on December 20, 2019. Caplyta belongs to the drug class called atypical antipsychotics. 

Caplyta price

Caplyta's cost is covered for approximately 90% of people with commercial insurance. With a Caplyta Savings Card, eligible patients may pay as little as $0 for their first 2 fills and $15 for subsequent fills.

For those with Medicaid and Medicare Part D, Caplyta is covered for more than 99% of people.

See Caplyta Prices, Coupons, Copay Cards & Patient Assistance for more information about the cost of Caplyta.

Caplyta side effects

The most common side effects of Caplyta are:

• sleepiness
• dizziness
• nausea
• dry mouth.

Caplyta does not appear to be associated with weight gain. See Does Caplyta cause weight gain? for more information.

Caplyta may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

Serious side effects and warnings

Caplyta carries a Boxed Warning for an increased risk of death in elderly patients with dementia-related psychosis and an increased risk for suicidal thoughts and behaviors in children and young adults.

Increased risk of death in elderly people with dementia-related psychosis. Medicines like Caplyta can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Caplyta is not approved for the treatment of people with dementia-related psychosis.

Increased risk of suicidal thoughts and actions. Caplyta and antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

• Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when Caplyta or the antidepressant medicine is started or when the dose is changed.
• Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
• Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
• Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
  • thoughts about suicide or dying • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood.

Caplyta can also cause the following serious side effects.

Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Caplyta is not approved for the treatment of people with dementia-related psychosis.

Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

• high fever
• confusion
• changes in your breathing, heart rate, and blood pressure
• stiff muscles
• increased sweating.

Uncontrolled body movements (tardive dyskinesia). Caplyta may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Caplyta. Tardive dyskinesia may also start after you stop taking Caplyta.

Problems with your metabolism such as:

• high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Caplyta. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start Caplyta, and then regularly during long-term treatment with Caplyta. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Caplyta:
  • feel very thirsty
  • need to urinate more than usual
  • feel very hungry
  • feel weak or tired
  • feel sick to your stomach
  • feel confused, or your breath smells fruity.
• increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start Caplyta, and then periodically during treatment with Caplyta.
• weight gain. You and your healthcare provider should check your weight before you start and often during treatment with Caplyta.

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with Caplyta.

Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position after taking Caplyta.

Falls. Caplyta may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Seizures (convulsions). Caplyta may increase your risk of seizures.

There is a risk that Caplyta may cause difficulty swallowing which can cause food or liquid to get into your lungs. Tell your healthcare provider immediately if this happens.

Problems controlling your body temperature so that you feel too warm.

Some people may be allergic to Caplyta or any of the inactive ingredients in the capsules. Get emergency medical help if you have signs of an allergic reaction to Caplyta such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

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

Before taking this medicine

You should not use Caplyta if you are allergic to Caplyta, lumateperone, or any of the ingredients in the capsules. Caplyta may also increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Before taking Caplyta, tell your healthcare provider about all your medical conditions, including if you have ever had:

• heart problems or a stroke
• high or low blood pressure
• have or have had diabetes or high blood sugar, or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start and during treatment with Caplyta.
• have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides or low levels of HDL cholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver problems
• have or have had a low white blood cell count
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Caplyta may harm your unborn baby. Taking Caplyta during the last 3 months of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take Caplyta during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Caplyta. Do not stop the medicine without your doctor's advice. If you become pregnant during treatment with Caplyta, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/ clinical-and-research-programs/pregnancyregistry/.

Breastfeeding

Caplyta passes into your breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby during treatment with Caplyta.

Fertility

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

How should I take Caplyta?

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

• Take Caplyta 1 time each day with or without food.
• You can take Capylta in the morning or at night but try to take it around the same time each day.
• Caplyta can cause drowsiness and sedation, but these side effects are not usually a problem when Caplyta is taken in the evening.
• Your treatment may also include weight control and frequent medical tests.

Caplyta dosing information

Usual Adult Dose of Caplyta for Schizophrenia: Caplyta 42 mg orally once a day

Usual Adult Dose of Caplyta for Bipolar 1 or 2 Disorder: Caplyta 42 mg orally once a day

• Use of Caplyta in bipolar disorder as monotherapy or as adjunctive therapy with lithium or valproate.

The dosage of Caplyta should be reduced in moderate to severe liver disease to Caplyta 21 mg once daily.

What happens if I miss a dose of Caplyta?

Take Caplyta 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.

What happens if I overdose?

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

What should I avoid while taking Caplyta?

Caplyta may make it difficult for you to control your body temperature so that you feel too warm. 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.

Caplyta can cause sleepiness and drowsiness, make you feel tired, or make it difficult for you to think and do normal activities. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can also cause falls, accidents, or severe injuries.

What other drugs will affect Caplyta?

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.

Related/similar drugs

Lybalvi, quetiapine, lamotrigine, aripiprazole, Abilify, olanzapine, Seroquel, risperidone, lithium

Caplyta storage

Store Caplyta at room temperature away from moisture and heat.

Caplyta ingredients

Active ingredient in Caplyta: lumateperone.
Inactive ingredients in Caplyta: croscarmellose sodium, gelatin, magnesium stearate, mannitol, and talc. Colorants include FD& C blue #1 and red #3 (42 mg), FDA/E172 black iron oxide, FDA/E172 red iron oxide and FD& C red #3 (10.5 mg), and titanium dioxide (42 mg, 21 mg, and 10.5 mg).

Available as Caplyta 42 mg, Caplyta 21 mg, and Caplyta 10.5 mg.

Who makes Caplyta

Intra-Cellular Therapies Inc. manufactures Caplyta.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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