Privacy Policy

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 HETLIOZPRO.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.

Information Collected.

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 HETLIOZ® (tasimelteon). When you do so, our registration process requires you to provide your name, telephone number, email address and certain additional information about your interest in HETLIOZ® (collectively, "Subscription Data").

We also may collect certain information automatically when you visit the Services, including:

  • Your browser type and operating system;
  • Your Internet Protocol (IP) address, which is the number automatically assigned to your computer whenever you access the Internet and that can sometimes be used to derive your general geographic area;
  • Other unique identifiers, including mobile device identification numbers;
  • Sites you visited before and after visiting the Services;
  • Pages you view and links you click on within the Services;
  • Information collected through cookies, web beacons, and other technologies;
  • Information about your interactions with e-mail messages, such as the links clicked on and whether the messages were opened or forwarded; and
  • Standard Server Log Information

Use of Information.

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 email, telephone, or otherwise about HETLIOZ® (tasimelteon), Vanda, and our products and services; to learn more about your experience with HETLIOZ®; 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.

Sharing of Information.

We are committed to maintaining your trust, and we want you to understand when and with whom we may share the information we collect.

  • Service Providers. We may share your information with service providers that perform certain functions or services on our behalf (such as to host the Services, manage databases, perform analyses, or send communications for us).
  • Other Parties When Required By Law or as Necessary to Protect the Services. We may disclose information to third parties if (1) required by law or (2) we have a good faith belief that such action is necessary to conform to applicable laws or comply with any legal, regulatory or similar requirement or investigation, to protect or defend the rights or property of Vanda, our corporate parents, affiliates, and subsidiaries, or the users of our Services or to enforce the Terms of Use.
  • In Connection With a Transfer of Assets. If we sell all or part of our business, or make a sale or transfer of assets, or are otherwise involved in a merger or business transfer, or in the event of bankruptcy, we may transfer your information to one or more third parties as part of that transaction.
  • Other Parties With Your Consent. We may share information about you with third parties when you consent to such sharing.

Security.

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.

Children’s Privacy.

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”).

Third Party Sites.

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.

Cookies, Pixel Tags, and Similar Technologies.

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.

Opt-Out.

You may elect to avoid future communications from Vanda by sending an email to opt-out@vandapharma.com with your electronic mail address.

Your California Privacy Rights

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.

Changes.

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.

Contact.

If you have any questions regarding this Privacy Policy or the Services, please contact Vanda at:
Vanda Pharmaceuticals Inc.
Attn: Privacy Statement
2200 Pennsylvania Ave NW
Suite 300E
Washington DC 20037
Tel: 202-734-3400
Email: privacy@vandapharma.com

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Healthcare Provider Important Safety Information

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.

Indication

HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQ® oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.

Important Safety Information

  • HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed, because HETLIOZ® can potentially impair the performance of activities requiring complete mental alertness.
  • The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.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
  • Use of HETLIOZ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ®, and a greater risk of adverse reactions. HETLIOZ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ®, with reduced efficacy.
  • There are no adequate and well-controlled studies of HETLIOZ® in pregnant women. Based on animal data, HETLIOZ® may cause fetal harm. Caution should be exercised when HETLIOZ® is administered to a nursing woman.
  • HETLIOZ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
  • The safety and effectiveness of HETLIOZ® for the treatment of Non-24 in pediatric patients 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full US Prescribing Information.