Caplyta (lumateperone) was approved for the treatment of schizophrenia in 2019 and for depressive episodes linked to bipolar I or bipolar II disorder (bipolar depression) in 2021. Caplyta can be used alone or with lithium or valproate for bipolar depression.
Caplyta is a second-generation antipsychotic. Antipsychotics are medicines for treating certain mental health conditions. Second-generation antipsychotics, also known as atypical or newer antipsychotics, generally cause fewer side effects than first-generation (typical or older) antipsychotics. They are less likely to cause involuntary movements (extrapyramidal effects), but many may cause weight gain and increased cholesterol. However, these effects were not common with Caplyta in studies.
How Does Caplyta Work for Schizophrenia and Bipolar Depression?
An imbalance of brain chemicals called neurotransmitters may contribute to schizophrenia and bipolar depression. The exact way Caplyta works is unknown. It may improve mood and behavior by blocking certain receptors in the brain that bind to the neurotransmitters serotonin and dopamine.
How Do I Take Caplyta?
Caplyta is usually taken as a 42-milligram capsule once daily, with or without food. But the dose may be decreased to 10.5 milligrams or 21 milligrams daily, depending on certain other drugs you may be taking or if you have liver problems.
How Was It Studied for the Treatment of Schizophrenia?
Two clinical studies evaluated the safety and effectiveness of Caplyta in adults with schizophrenia. In both studies, people took either Caplyta or a placebo (a pill with no medicine). The average age was 42-44 years and ranged from 19 to 60 years. Up to 23% of the people studied were female, up to 26% were Caucasian, and up to 78% were African American. The effect of Caplyta was measured using a rating scale that evaluates how severe schizophrenia symptoms are. Higher scores mean more severe symptoms. Most people had severe symptoms of schizophrenia at the start of the studies.
During both studies, scores on the rating scale for schizophrenia decreased, showing that Caplyta made schizophrenia symptoms less severe. Caplyta was also better than the placebo at managing symptoms such as hallucinations, delusions, and disorganized thoughts.
How Was Caplyta Studied for the Treatment of Bipolar Depression?
Two clinical studies evaluated the safety and effectiveness of Caplyta in adults with bipolar depression. One study compared Caplyta to a placebo. The other study compared adding Caplyta to either lithium or valproate to adding the placebo to lithium or valproate. The average age was 45-46 years and ranged from 18 to 74 years. Up to 58% of the people studied were female, up to 91% were Caucasian, and up to 11% were African American. The effect of Caplyta was measured using a depression rating scale. A higher score on the scale means more severe depression symptoms. People had moderate to severe depression symptoms when the studies began.
During both studies, patients taking Caplyta showed improvement in depression symptoms of bipolar disorder. Caplyta was also better than the placebo at making symptoms less severe.
How Long Does It Take for Caplyta to Work?
You may see effects for schizophrenia and bipolar depression start within 1-2 weeks, but it may take 4-6 weeks before you reach the full effect of Caplyta. If symptoms do not improve after 4-6 weeks of treatment, contact your health care provider.
What Are the Possible Side Effects, and How Can I Prevent or Manage Them?
The most common side effects of Caplyta are sleepiness, dizziness, nausea, and dry mouth. Dizziness or sleepiness may cause falls. If you feel dizzy, avoid sudden head movements or getting up quickly from a sitting or lying position. If you feel sleepy, try taking it before bed in the evening. Avoid driving and doing other tasks or actions that require alertness until you know how Caplyta affects you. If you have a dry mouth, try sipping water frequently, sucking on ice chips, chewing sugar-free gum, or sucking on sugar-free candy.
While not common with Caplyta, antipsychotics may lead to weight gain, high blood pressure, diabetes, or high cholesterol. Your health care provider will monitor your weight, blood pressure, cholesterol level, hemoglobin A1c (a measure of blood sugar over time), and waist circumference. Healthy lifestyle choices such as exercising; controlling portion sizes; eating more vegetables, fruits, and lean meats; and limiting unhealthy fats and salt can help prevent these side effects. For more information on adopting a healthy lifestyle, visit the American Heart Association website at https://www.heart.org/en/.
Caplyta may cause problems with body temperature, making it difficult for your body to cool down (heat intolerance). Heavy exercise, extreme heat, dehydration, and certain medicines may worsen heat intolerance. Wearing lightweight clothing, staying hydrated, avoiding extreme heat, and exercising in cooler weather are some ways to help prevent heat intolerance.
Caplyta may cause trouble swallowing. You may cough or choke while eating and drinking, which can cause food or liquid to get into your lungs. Tell your health care provider right away if you are having trouble swallowing.
Caplyta can cause low white blood cell counts, increasing your risk of infection. For the first few months after starting Caplyta, you may need blood tests to measure your level of white blood cells.
Caplyta may cause tardive dyskinesia (TD), which causes stiff, jerky movements of the face and body that you cannot control. TD may not go away even if you stop taking Caplyta and may start after you stop taking Caplyta. Tell your health care provider right away if you have movements that you cannot control.
Caplyta may increase the chances of suicidal thoughts or actions in children or young adults, especially in the first few months of treatment and when your dose is changed. This risk may be increased in people with a history of these thoughts or actions. Call your health care provider right away if you have any signs of new or worsening depression or changes in mood, thoughts, or behaviors.
Adults older than 65 years with dementia have a higher risk of stroke, which may lead to death. Caplyta is not approved to treat dementia.
A rare but deadly health condition called neuroleptic malignant syndrome may happen. Call your health care provider right away if you have a high fever; muscle cramps or stiffness; confusion; changes in heart rate, breathing, or blood pressure; or increased sweating.
These are not all of the possible side effects of Caplyta. Talk with your health care provider if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
What Interactions With Foods and Other Medicines Can Happen?
Several medicines can affect the levels of Caplyta in your body. This may increase the risk of side effects from Caplyta or can cause it not to work as well. Tell your health care provider about all the medicines you take. Your dose may need to be adjusted when taken with certain medicines. Do not start or stop other medicines while taking Caplyta without talking to your health care provider.
How to Pay for Your Prescription
A copay card from the drugmaker may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at https://www.caplyta.com/bipolar/savings-offer or https://www.caplytahcp.com/schizophrenia/patient-savings-support.
For questions about cost, insurance coverage, or any other questions, you can also contact the drugmaker at 888‑252‑4824.
