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’ interest and browsing habits. The information set out in the policy is provided in addition to, and should be read alongside, our privacy policy which you can find 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.
  • Advertising/Marketing (Social Media and Targeting) – this includes the use of cookies to track you for advertising purposes so that we or our advertising partners can select and display relevant ads, including displaying ads relating to our business when you navigate to other websites. These cookies are also used by services provided by third-parties on our website or services.

Depending on applicable law, we may offer you choices as to how we use cookies. However, our use of Necessary cookies is required to make our website and services function properly, and therefore we do not provide choices regarding the use of these cookies.

Cookies Used on this Website

Please click to view a list of cookies in use on our site, grouped by reference to the purposes described above.

We use Google Analytics to gather information about the use of our website. This may involve the use of cookies from Google on our website. 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 preference center pop-up, which you can also access by clicking . If required, you can choose to provide or withhold your consent for each of the purposes for which cookies are deployed (except for 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, or to opt-out of targeted advertising. For example, under the California Consumer Privacy Act, our use of third-party advertising and analytics cookies may be considered a "sale," but note that we do not "sell" your personal information for monetary consideration.

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 .

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 June 19, 2023.

Our Details

This website is owned and operated by Intra‑Cellular Therapies, with its corporate headquarters at 430 East 29th Street, Suite 900, New York, NY 10016.

You can contact us:

  1. by post, to 430 East 29th Street, Suite 900, New York, NY 10016;
  2. by telephone, on +1 (646) 440-9333; or
  3. by email, using [email protected].

CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Important Safety Information

Boxed Warnings:

  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
  • Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and provide intensive symptomatic treatment and monitoring.
  • Tardive Dyskinesia (TD), a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. Given these considerations, CAPLYTA should be prescribed in a manner most likely to reduce the risk of TD. Discontinue CAPLYTA if clinically appropriate.
  • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
  • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
  • Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
  • Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
  • Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
  • Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
  • Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
  • Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

Drug Interactions: Avoid concomitant use with CYP3A4 inducers. Reduce dose for concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4 inhibitors (21 mg).

Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Reduce dose for patients with moderate or severe hepatic impairment (21 mg).

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs placebo were:

  • Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%).
  • Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9% vs 4%), and dry mouth (5% vs 1%, 5% vs 1%).

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Indications

CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Please see full Prescribing Information, including Boxed Warnings.

Boxed Warnings:

  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.