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Caplyta

Generic name: lumateperoneLOO-ma-TE-per-one ]
Drug class: Atypical antipsychotics

Medically reviewed by Judith Stewart, BPharm. Last updated on Aug 1, 2022.

What is Caplyta?

Caplyta capsules contain lumateperone, an antipsychotic medicine.

Caplyta is a once-daily capsule used to control the symptoms of schizophrenia in adults.

Although the physical cause of schizophrenia is unknown, it is believed that imbalances between chemicals, such as dopamine, serotonin, and glutamate, in the brain is the probable cause. The exact way Caplyta works is unknown but it is thought to affect the balance of these brain-signaling chemicals to help control schizophrenia symptoms.

Caplyta is also used alone or with the medicine lithium or valproate to treat depressive episodes that happen with bipolar disorder (manic depression).

Warnings

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.

Before taking this medicine

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

Caplyta 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:

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Caplyta 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.

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

Is is not known if this medicine is safe and effective in children.

How should I take Caplyta?

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

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

You will need frequent medical tests.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, or heavy sweating. Call your doctor if you are sick with vomiting or diarrhea.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Schizophrenia:

42 mg orally once a day

Comments:
-Dose titration is not necessary.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Depression

42 mg orally once a day

Comments:
-Dose titration is not necessary.

Use: Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate

What happens if I miss a dose?

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.

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?

While you are taking Caplyta, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

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

Grapefruit may interact with lumateperone and lead to unwanted side effects. Avoid the use of grapefruit products.

Caplyta side effects

Get emergency medical help if you have signs of an allergic reaction to 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 lumateperone 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.

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:

  • weight gain;

  • 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.

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 affect Caplyta, especially:

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.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Caplyta only for the indication prescribed.

Popular FAQ

Does Caplyta cause weight gain?

Caplyta (lumateperone) treatment is not associated with the weight gain that some other antipsychotic drugs are. Caplyta is an atypical antipsychotic that is used to treat schizophrenia and bipolar depression in adults.

Results from a number of trials combined together showed that the weight gain observed in patients treated with Caplyta was similar to the weight gain observed in patients who received placebo.

Positive results were also reported by a study that followed patients for one year after they switched from standard of care to Caplyta. Significant improvements in mean body weight were observed during the year of treatment with Caplyta (-2.1  kg, P <0.001) when mean body weights from the beginning and end of the year were compared. Significant reductions in body mass index (BMI) and waist circumference were also observed.

When should I take Caplyta?

Caplyta (lumateperone) should be taken once a day with or without food. The recommended dosage of Caplyta is one 42mg capsule a day. Caplyta can cause somnolence and sedation, but these side effects are reported less frequently when Caplyta is taken in the evening.

How long does it take Caplyta to work?

Patient with schizophrenia started to show improved Positive and Negative Syndrome Scale (PANSS) total scores after one week of treatment with Caplyta (lumateperone), according to the results of a phase III trial. PANSS is a scale used to measure the severity of schizophrenia symptoms. Symptoms continue to improve the longer you take the drug.

While there may be some signs of improvement during the initial weeks of treatment, it can take up to 2-3 months for the full effects of Caplyta to be felt in patients with schizophrenia.

In the first 1-2 weeks, hallucinations, disorganized thinking and delusions may improve, although sometimes they won’t go away altogether. It can also take at least 1-2 weeks for motivation and the desire to be around other people to improve.

Patients with bipolar depression also started to show improvement in their symptoms during the initial weeks of treatment with Caplyta, according to the results of another phase III trial. At the end of the 6 week trial, patients with bipolar depression treated with Caplyta 42mg day showed a statistically significant improvement in their symptoms compared with patients receiving placebo.

Further information

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