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Vanda Pharmaceuticals Inc. values your privacy and the security of your information. This Privacy Policy explains how Vanda ("Vanda," "we," or "us") collects and uses information obtained from users in connection with HETLIOZ.com and any of our other sites or services that link to this Privacy Policy (collectively, the "Services"). Please read the entire Privacy Policy before using our Services. By using the Services, you agree to abide by the terms of this Privacy Policy.
You generally are not required to provide information about yourself when you visit the Services. However, we may ask you for some or all of the following types of information when you request additional information about Non-24-Hour Sleep-Wake Disorder (Non-24) and HETLIOZ® (tasimelteon); request tools, resources, and information about events for the blindness community; share a personal experience with Non-24 and HETLIOZ®; access various content or features; submit content; or directly contact us with questions or feedback.
We also may collect certain information automatically when you visit the Services, including:
Vanda may use information that we collect through the Services to provide you with products, promotions, services, newsletters, and information in accordance with your preferences, and to respond to correspondence that we receive from you. Sometimes, we may use the information that we collect to contact you via e-mail, telephone, or otherwise about medicines that treat Non-24, Vanda, and our products and services; to learn more about your experience with Non-24; or to otherwise provide you with information that might be of interest to you. At your election at any time, you may choose to stop receiving future communications from Vanda ("opt-out;" see below for more information on how to opt-out).
We also may use information that we collect to maintain or administer the Services, perform business analyses, or for other internal purposes to improve the quality of our business, the Services, and other products and services we offer. For example, Vanda uses information collected automatically to help diagnose problems with its server, analyze trends, and administer the Services. We also may use information that you provide to customize and personalize your use of the Services and as otherwise described to you at the point of collection or pursuant to your consent.
We are committed to maintaining your trust, and we want you to understand when and with whom we may share the information we collect.
We take a number of steps to help protect against loss, misuse, unauthorized access, disclosure, alteration or destruction of the information you provide to us. Unfortunately, no data transmission over the Internet can be guaranteed to be 100% secure. As a result, Vanda cannot ensure the security of any information you provide, and you do so at your own risk.
The Services do not knowingly collect, use, or disclose personal information from children under the age of 13 without prior parental consent, except as permitted by the Children's Online Privacy Protection Act ("COPPA").
The Services may permit you to link to other websites on the Internet, and other websites may contain links to the Services. These other websites are not under Vanda's control. The privacy and security practices of websites linked to or from the Services are not covered by this Privacy Policy, and Vanda is not responsible for the privacy or security practices or the content of such websites.
Vanda also uses cookies, pixel tags, Local Shared Objects, and similar technologies to automatically collect certain information, such as your browser type and operating system, IP address, and other unique identifiers. "Cookies" are pieces of information that a website transfers to your computer's hard disk for record-keeping purposes. Pixel tags are very small images or small pieces of data embedded in images, also known as "web beacons" or "clear GIFs," that can recognize cookies, the time and date a page is viewed, a description of the page where the pixel tag is placed, and similar information from your computer or device. Local Shared Objects (sometimes referred to as "Flash Cookies") are similar to standard cookies except that they can be larger and are downloaded to a computer or mobile device by the Adobe Flash media player. Vanda generally uses cookies and similar technologies to determine which areas of the Services users have visited and to compare users' experiences in using the Services so that it may better tailor the Services for them. You may be able to set your web browser to refuse cookies. However, if you choose to reject cookies, you may not be able to use certain online products, services or features on the Services. Please note that you may need to take additional steps beyond changing your browser settings to refuse or disable Local Shared Objects and similar technologies. For example, Local Shared Objects can be controlled through the instructions on Adobe's Setting Manager page. By using the Services, you consent to our use of cookies and similar technologies.
We may allow third parties to place and read their own cookies, pixel tags, web beacons, Local Shared Objects, and similar technologies to collect information through the Services. For example, our third-party service providers may use these technologies to collect information that helps us with traffic measurement, research, analytics, and providing you with relevant advertisements.
Vanda has worked with certain third-party social media providers to offer you their social networking services through our Services. For example, you can use third-party social networking services, including but not limited to Facebook, Twitter, and others to share information about your experience on our Services with your friends and followers on those social networking services. These social networking services may be able to collect information about you, including your activity on our Services. These third-party social networking services also may notify your friends, both on our Services and on the social networking services themselves, that you are a user of our Services or about your use of our Services, in accordance with applicable law and their own privacy policies. If you choose to access or make use of third-party social networking services, we may receive information about you that you have made available to those social networking services, including information about your contacts on those social networking services.
You may elect to avoid future e-mail communications from Vanda by sending an e-mail to opt-out@vandapharma.com with your electronic mail address.
Some web browsers may transmit "do-not-track" signals to the websites with which the user communicates. Because of differences in how web browsers incorporate and activate this feature, it is not always clear whether users intend for these signals to be transmitted, or whether they even are aware of them. Because there currently is no industry standard concerning what, if anything, websites should do when they receive such signals, we currently do not take action in response to these signals. If and when a final standard is established and accepted, we will reassess how to respond to these signals. In some cases, third parties may be able to collect information about a user's online activities over time and across different websites when he or she uses our Services.
Vanda does not share information that it collects with third parties for the third party's direct marketing purposes.
Vanda reserves the right to change or update this Privacy Policy at any time by posting a notice on the Services. Information collected by the Services is subject to the Privacy Policy in effect at the time of use.
If you have any questions regarding this Privacy Policy or the Services, please contact Vanda at: Vanda Pharmaceuticals Inc., Attn : Privacy Statement, 2200 Pennsylvania Avenue NW, Suite #300E, Washington DC 20037, Tel : 202.734.3400, E-mail : privacy@vandapharma.com
Indications
HETLIOZ® (HeT-lee-ōz) [tasimelteon] capsules are indicated for the treatment of:
HETLIOZ LQ® (HeT-lee-oz el-Cue) oral suspension is indicated for:
Important Safety Information
HETLIOZ® may cause drowsiness. After taking HETLIOZ®, limit your activity to preparing for bed. HETLIOZ® can potentially impair your ability to perform activities that require complete mental alertness.
The most common side effects associated with HETLIOZ® include headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and upper respiratory or urinary tract infection. These side effects may occur more frequently in patients 65 years of age or older. Adverse reactions were similar in patients treated for (Non-24) and patients with SMS treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ® oral suspension, and patients ≥16 years of age who received HETLIOZ® capsules.
Tell your healthcare provider about all of the medicines you're taking. HETLIOZ® should not be taken in combination with fluvoxamine or rifampin.
Tell your healthcare provider about all of your health conditions, including whether you are pregnant, are planning to become pregnant, or are breastfeeding. HETLIOZ® has not been studied in pregnant women.
The safety and effectiveness of HETLIOZ® for the treatment of Non-24-Hour in children have not been established. The safety and effectiveness of HETLIOZ LQ® oral suspension for the treatment of nighttime sleep disturbances in SMS have been established in pediatric patients 3 years and older.
HETLIOZ® is not recommended for use in patients with severe liver problems.
Consumer Important Safety Information
You are encouraged to report side effects of prescription drugs to the FDA. To report side effects, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-0178 or www.fda.gov/medwatch.
For more information, ask your healthcare provider or call 1-844-HETLIOZ (1-844-438-5469).
This information does not take the place of talking with your healthcare provider for medical advice about your condition or treatment.
Download an accessible PDF or listen to the full US Prescribing Information. You can also hear the full US Prescribing Information by calling 1-844-HETLIOZ (1-844-438-5469).