Schizophrenia What to Know About Caplyta (Lumateperone) An atypical antipsychotic for the treatment of adult schizophrenia. By Kendra Cherry Kendra Cherry Facebook Twitter Kendra Cherry, MS, is an author and educational consultant focused on helping students learn about psychology. Learn about our editorial process Updated on February 13, 2022 Medically reviewed Verywell Mind articles are reviewed by board-certified physicians and mental healthcare professionals. Medical Reviewers confirm the content is thorough and accurate, reflecting the latest evidence-based research. Content is reviewed before publication and upon substantial updates. Learn more. by Daniel B. Block, MD Medically reviewed by Daniel B. Block, MD LinkedIn Twitter Daniel B. Block, MD, is an award-winning, board-certified psychiatrist who operates a private practice in Pennsylvania. Learn about our Medical Review Board Print Owaki / Kulla / Getty Images Table of Contents View All Table of Contents Uses Before Taking Dosage Side Effects Warnings and Interactions Caplyta (lumateperone) is an atypical antipsychotic medication that is used for the treatment of schizophrenia in adults. Schizophrenia is a lifelong brain disorder that causes symptoms such as delusions, hallucinations, disorganized speech, and changes in emotional expression. Caplyta is taken as a capsule one time each day. The exact mechanism of action is not fully understood, but the medication is believed to act as an antagonist on certain serotonin and dopamine receptors. In clinical trials, the drug was shown to improve symptoms of schizophrenia. There is no generic version of the medication available. Caplyta Uses Caplyta is approved for the treatment of schizophrenia in adults. Caplyta works by affecting dopamine, serotonin, and glutamate in order to improve symptoms that affect mood, thoughts, and behaviors. The medication may help with some of the symptoms of schizophrenia, which can improve functioning in daily life. Some of the symptoms of schizophrenia include: Agitation Delusions Disorganized behavior Disorganized thinking Hallucinations Lack of emotional expression It was first approved by the Food and Drug Administration for the treatment of schizophrenia on December 20, 2019. Off-Label Uses Caplyta may also be prescribed off-label to treat some other mental health conditions. When a medication is prescribed off-label, it means that it has not been FDA-approved for that use. However, your doctor may choose to prescribe the medication if they believe it may provide some benefits for your condition. For example, some other atypical antipsychotics are sometimes prescribed off-label to treat conditions such as bipolar disorder, attention-deficit hyperactivity disorder (ADHD), anxiety, and depression. Caplyta is currently being evaluated for use in the treatment of bipolar disorder, behavioral disturbances in people with dementia, depression, and other neurological conditions. However, its safety and efficacy for those conditions have not been established. Before Taking Caplyta If you think that Caplyta might be right for you, it is important to talk to your doctor. Before prescribing this medication, your doctor will first need to evaluate your symptoms and make a diagnosis. This also means that your doctor will need to rule out other conditions that may be causing your symptoms. Your doctor may make the decision to prescribe Caplyta based on your individual symptoms, the potential side effects, and your past response to other schizophrenia medications. Be sure to also talk to your doctor about any other medications or supplements that you are currently taking. Some may have the potential to cause drug interactions that may be dangerous or impact the efficacy of either medication. Precautions and Contraindications People who have a known sensitivity to lumateperone or other components of Caplyta should not take this medication. It should also not be used to treat dementia-related psychosis. Antipsychotic drugs such as Caplyta may also increase the risk of neuroleptic malignant syndrome (NMS), which can be potentially fatal and cause symptoms including autonomic instability, delirium, hyperpyrexia, and muscle rigidity. If a person experiences such symptoms, the use of Caplyta should be discontinued immediately and they should be closely monitored and treated for associated symptoms. Caplyta Dosage According to the prescribing information, Caplyta is available as a 42 milligram (mg) strength capsule. All listed dosages are according to the drug manufacturer. Check your prescription and talk to your doctor to make sure you are taking the right dose for you. How to Take and Store It should be taken once each day with food. The medication should be stored at room temperature between 68°F to 77°F. The drug can be taken while traveling but should be kept between 59°F to 86°F during outings. If you forget to take the medication, take it as soon as you can but skip the missed dose if it is almost time for your next one. Do not take two doses at the same time. Caplyta Side Effects Caplyta has the potential to cause some side effects. Common The two most common side effects of Caplyta are dry mouth and sleepiness. Severe Some of the more serious adverse effects that may occur while taking Caplyta include: Decreased blood pressure upon standing which may lead to loss of consciousness Impaired ability to operate vehicles or heavy equipment Increased risk of falls Increased risk of stroke and death in older individuals who have dementia-related psychosis Low white blood cell counts Seizures Tardive dyskinesia, which involves the uncontrolled movements of the face and body Weight gain and high blood glucose Some people may also experience problems with temperature regulation. Caution should be used during strenuous exercise and care should be taken to avoid dehydration and heat exposure. Warnings and Interactions Antipsychotic drugs such as Caplyta have been associated with metabolic changes such as diabetes mellitus and hyperglycemia. In one trial, approximately 4.7% of patients who were taking Caplyta experienced increases in A1C levels. You should be monitored for symptoms of hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain when you begin taking the medication and checked periodically during long-term treatment. Leukopenia and neutropenia, which involve decreases in white blood cells needed to fight infections, may also occur during treatment with Caplyta and other antipsychotic medications. Fatal cases of agranulocytosis, which involves decreases in white blood cells called granulocytes, have also been reported with other medications in this same class. Individuals who have a history of low white blood cell counts (WBC) should be monitored and the use of Caplyta should be discontinued if there is a significant drop in WBC. Caplyta carries a black box warning for adverse cerebrovascular reactions, which may include stroke, in elderly patients who have dementia-related psychosis. You should avoid taking Caplyta with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors, and UGT inhibitors. Taking these medications together can increase the risk for adverse reactions. Drugs that may lead to interactions include: Amprenavir Ciprofloxacin Erythromycin Fluvoxamine Clarithromycin Nefazodone Modafinil Prednisone Valproic acid You should also avoid taking Caplyta with grapefruit juice and St. John's wort. Avoid using drugs or alcohol while you are taking Caplyta as these substances may decrease the effectiveness of your medication and increase the risk of experiencing adverse effects such as sedation. Always tell your doctor about any medications, supplements, or substances you are currently taking before you begin taking Caplyta. Taking Caplyta during the third trimester of pregnancy may lead to withdrawal or extrapyramidal symptoms in the infant. There is no estimate of the risk of miscarriage or birth defects that may result from taking Caplyta. You should discuss the risks and benefits of taking this medication during pregnancy with your doctor. Always take your medication as directed by your doctor. Do not stop taking your medication, even if you are feeling better. If you are concerned about side effects or some other aspect of your medication, talk to your doctor first before you stop taking or change the dosage. 7 Sources Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Davis RE, Correll CU. ITI-007 in the treatment of schizophrenia: from novel pharmacology to clinical outcomes. Expert Review of Neurotherapeutics. 2016;16(6):601-614. doi:10.1080/14737175.2016.1174577 Intracellular Therapies. Clinical pharmacology of Caplyta. Maglione M, Maher AR, Hu J, et al. Off-Label Use of Atypical Antipsychotics: An Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Sep. (Comparative Effectiveness Reviews, No. 43.) Introduction. Intra-Cellular Therapies, Inc. A phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with bipolar i or bipolar Ii disorder (bipolar depression) conducted globally. clinicaltrials.gov; 2020. Intra-Cellular Therapies. FDA approves Intra-Cellular Therapies' novel antipsychotic, Caplyta (lumateperone) for the treatment of schizophrenia in adults. Food and Drug Administration (FDA). Highlights of prescribing information: Caplyta (lumateperone). Food and Drug Administration (FDA). Drug trials snapshots: Caplyta. By Kendra Cherry Kendra Cherry, MS, is an author and educational consultant focused on helping students learn about psychology. See Our Editorial Process Meet Our Review Board Share Feedback Was this page helpful? Thanks for your feedback! What is your feedback? 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