Cookie Policy - CAPLYTA® (lumateperone) Skip to Main Content For US Residents Only Visit US Healthcare Professionals Site Important Safety Information Prescribing Information Medication Guide Other Indication Cost & Savings Important Safety Information Medication Guide Other Indication Cost & Savings Your browser does not support the audio element. Close Menu Major Depressive Disorder Bipolar Depression For US Residents only Prescribing Information Visit US Healthcare Professionals Site Your browser does not support the audio element. Major Depressive Disorder Bipolar Depression Cookie Policy Introduction Our website uses cookies and similar technologies to provide a more relevant and personalized browsing experience, including ads based on our users' interests and browsing habits. The information set out in this policy is provided in addition to, and should be read alongside, our privacy policy which you can find by clicking here . We respect our users' privacy and rights to opt‑in or opt‑out of our use of their personal information for certain advertising purposes as provided by applicable law. To opt‑in or opt‑out of our use of personal information and cookies for certain purposes, please use the resources and options provided below. About cookies Cookies are alphanumeric identifiers that we transfer to your device's hard drive through your web browser for record‑keeping purposes. Some cookies allow us to make it easier for you to navigate our website, while others allow us to track your activities in our website, support the security and performance of the Services, or allow us to track activity and usage data within the website. Cookies may either be "persistent" cookies or "session" cookies. A persistent cookie will be stored by a web browser and will remain valid until its set expiry date, unless deleted by the user before the expiry date. A session cookie, on the other hand, will expire at the end of the user session, when the web browser is closed. Cookies do not typically contain any information that personally identifies a user, but personal data that we store about you may be linked to the information stored in and obtained from cookies. Additionally, certain laws consider cookie identifiers to be "personal data" or "personal information," and, when applicable, we will treat them as such. Purpose for Using Cookies We use cookies and related technologies for the following purposes: Strictly Necessary – this includes the use of any cookies that are essential to enable you to move around the website or service and use their features. Without these cookies, services you have asked for (such as navigating between pages or staying logged in) cannot be provided. We also use cookies which are strictly necessary to allow you to access our website or services and to receive the services which you have requested. This also includes cookies used to comply with legal obligations which apply to our website, such as our obligation to take appropriate steps to secure personal information input into the website. The types of data usually collected by these cookies includes session identifier; IP address; webpage URL; referring website; and security tokens. Analytics (Performance) – this includes the use of cookies to collect statistical and analytics information about how our visitors use our website or service, and to monitor our website or service performance. This allows us to provide a high‑quality experience by customizing our offering and quickly identifying and fixing any issues that arise. We might use these cookies to display or highlight resources or articles we think may be most relevant to you based on your use of the website or services. 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The information gathered is used to create reports about the use of our website. You can find out more about Google's use of information by visiting https://www.google.com/policies/privacy/partners/ and you can review Google's privacy policy at https://policies.google.com/privacy . Managing Cookies – Your Choices Note: The following opt‑in/opt‑out options are limited to the device and web browser you use to make your selection. If you use another device or browser, or if you change devices or browsers, you will need to opt‑out on each device and browser. If you block or clear cookies from your browser, it may remove the opt‑out setting, requiring you to opt‑out again. a. Opt‑In In some countries or jurisdictions in which we operate, we may be required to ask for your consent to use all non‑Necessary cookies. If required by law, when you first navigate to our website you will be asked to provide your consent to cookies through a cookie pop‑up, which you can also access by clicking here . If required, you can choose to provide or withhold your consent for each of the purposes for which cookies are deployed (except for Strictly Necessary cookies). You can withdraw your consent at any time using the cookie preferences center linked above but note that withdrawal of your consent will not be retroactive. For more information about the legal bases on which we rely to collect, use, and process personal information, please see our privacy policy by clicking here . b. Opt‑Out In some countries or jurisdictions in which we operate, we may be required to give you the option to opt‑out of certain cookies, such as third‑party advertising and tracking cookies. This may be known as the right to opt‑out of "sale" or "sharing" of personal information, to opt‑out of targeted advertising, or to limit the use and disclosure of sensitive personal information. For example, under the California Consumer Privacy Act, our use of third‑party advertising and analytics cookies may be considered a "sale." If required by law, when you first navigate to our website you will be shown a cookie pop‑up with the option to opt‑out of our use of certain third‑party advertising and tracking cookies, which you can also access by clicking here . You also have the right to opt‑out of “sales” and “sharing” of your personal information using an opt‑out preference signal. If our site detects that your browser or device is transmitting an opt‑out preference signal, such as the “global privacy control”—or GPC— signal, we will opt that browser or device out of the use of cookies or other tools on our site that result in a “sale” or “sharing” of your personal information. If you come to our site from a different device or from a different browser on the same device, or if you clear your cookies, you will need to opt‑out again, or use an opt‑out preference signal, for that browser and/or device as well. c. Browser‑Based and Industry Solutions Alternatively, most web browsers allow some control of most cookies through the browser settings. The methods for doing so vary from browser to browser, and from version to version. The Help portion of the toolbar on most browsers will tell you how to prevent your device from accepting new cookies, how to have the browser notify you when you receive a new cookie, or how to disable cookies altogether. Visitors to our website and services who disable cookies will be able to browse the website, but some features may not function. You may go to the Digital Advertising Alliance ("DAA") Consumer Choice Page for information about opting out of interest‑based advertising and their choices regarding having information used by DAA companies. You may also go to the Network Advertising Initiative ("NAI") Consumer Opt‑Out Page for information about opting out of interest‑based advertising and their choices regarding having information used by NAI members. Opting out from one or more companies listed on the DAA Consumer Choice Page or the NAI Consumer Opt‑Out Page will opt you out from those companies' delivery of interest‑based content or ads to you, but it does not mean you will no longer receive any advertising through our website or on other websites. You may continue to receive advertisements, for example, based on the website that you are viewing (i.e., contextually based ads). Also, if your browser is configured to reject cookies when you opt out on the DAA or NAI websites, your opt‑out choice may not be effective. Additional information is available on the DAA's website at www.aboutads.info or the NAI's website at www.networkadvertising.org . You may also visit https://youronlinechoices.eu/ for more information about privacy choices in the EU. You can also download the Google Analytics opt‑out browser add‑on to prevent their data from being used by Google Analytics at https://tools.google.com/dlpage/gaoptout . If you block cookies, you may have to reset your preferences on our website. You may also not be able to use all the features on our website. Changes to the Cookie Policy We may update this cookie policy at any time as needed, and we encourage you to review this policy from time to time. This cookie policy was last updated on March 10, 2025. Our Details This website is owned and operated by Intra‑Cellular Therapies, with its corporate headquarters at 135 Route 202/206, Suite 6, Bedminster, NJ 07921. You can contact us: by post, to 135 Route 202/206, Suite 6, Bedminster, NJ 07921; by telephone, on +1 (646) 440‑9333 ; or by email, using info@itci‑inc.com . Important Safety Information and Indications Expand IMPORTANT SAFETY INFORMATION 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 treating people with dementia-related psychosis. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms to your healthcare provider immediately. Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat). CAPLYTA may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS. Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA. Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity. 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, dizzy, or faint when you rise too quickly from a sitting or lying position. 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 broken bones or other injuries. Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities. Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA. Difficulty swallowing that can cause food or liquid to get into the lungs. The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These are not all the possible side effects of CAPLYTA. Tell your healthcare provider if you have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems. CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk. Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. INDICATIONS CAPLYTA is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children. Please see Medication Guide , including Boxed WARNINGS. IMPORTANT SAFETY INFORMATION 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 treating people with dementia-related psychosis. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms to your healthcare provider immediately. Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat). CAPLYTA may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS. Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA. Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity. 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, dizzy, or faint when you rise too quickly from a sitting or lying position. 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 broken bones or other injuries. Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities. Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA. Difficulty swallowing that can cause food or liquid to get into the lungs. The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These are not all the possible side effects of CAPLYTA. Tell your healthcare provider if you have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems. CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk. Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. INDICATIONS CAPLYTA is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children. Please see Medication Guide , including Boxed WARNINGS. Terms of Use Privacy Policy Cookie Policy Contact Us ITCI Corporate Site Sitemap Your Privacy Choices AdChoices Opt-Out © Johnson & Johnson and its affiliates 2025. CAPLYTA and LET IN THE LYTE are trademarks of Johnson & Johnson and its affiliates. Trademarks listed are the property of their respective owners. 11/25 US-CAP-2500128