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Privacy Policy

Harmony Biosciences, LLC, ("Harmony") and its affiliates value your privacy and the security of your personal information. This notice explains our online information practices and the choices you can make about the way your information is collected and used.

This Privacy Policy applies only to the use and collection of data collected by this website, its services, and related mobile applications, and does not apply to any other data collected by Harmony online or offline unless specifically linked to this Privacy Policy.

Harmony Biosciences, LLC, operates our websites and any mobile applications that are owned by us. As used in this Privacy Policy, "We" includes Harmony and its related companies, as well as any third-party vendors we hire to assist in administration of the website. These vendors are required to maintain the confidentiality of user information in accordance with the terms of this Privacy Policy and to otherwise abide by the terms of this Privacy Policy. These vendors are prohibited from using the user information for any other purpose.

We encourage you to read the Privacy Policy in its entirety before using the site. By accessing and using the site or its services, you agree to the collection and use of information in accordance with this Privacy Policy, as well as to the Terms of Use.

Information We May Collect
You can visit our site without providing any personally identifiable information, and we do not collect any personally identifiable information without your consent. Please note that if you choose not to provide personally identifiable information when it is requested, you may not be able to take full advantage of the functionality and services of this site.

If personally identifiable information and non–personally identifiable information are collected as detailed below, we may use both types of information to create aggregated (non–personally identifiable) statistical information.

Personally Identifiable Information

Harmony may request personal data when you engage with certain functions of the site (for example, if you request more information, contact us directly with feedback or questions, or opt in to any of the site’s offerings). If you do not want Harmony to collect your personally identifiable information, please do not provide it to us. Personal data includes information that identifies you as an individual or relates to an identifiable individual and will be collected only if specifically requested and provided by you. The personal data we request may include:

  • name
  • date of birth
  • email address
  • home address
  • phone number
  • professional credentials and practice details (for example, location and specialty), including identification number if applicable
  • additional information as otherwise described to you at the point of collection or pursuant to your consent

In addition, Harmony may occasionally request and obtain sensitive health-related personal data about you through channels related to this site (for example, if you voluntarily provide information about your physical or mental health as part of a request for information or survey). By providing us with your sensitive personal data, you consent to us processing these data for the purposes set out in this Privacy Policy.

Non–Personally Identifiable Information
Harmony collects basic technical information from all users during visits to the site through automatic data collection tools, which may include cookies and other commonly used technologies. These tools collect certain standard information sent to the site from your browser, such as your browser type and language, access times, and the addresses of other websites you visit before and after visiting our site. They may also collect information about your Internet Protocol (IP) address, or actions taken (clicks) as you interact with the site. Please see below for additional detail about the information we collect through cookies and other commonly used technologies. By using the Services, you consent to our use of cookies and similar technologies.

How We Use Your Information
We use your personal data to register you for services that you have signed up for, to communicate with you about your use of our services, to respond to questions or requests, and for other customer service purposes. Harmony Biosciences also uses the data that we collect from our site to operate our business, and provide and improve the services we offer. We will only share your personal data in ways that are described in this Privacy Policy.

At any time, you may choose to opt out of communications from Harmony. See below for more information on how to opt out.

Cookies
Cookies are small data files that may include an anonymous unique identifier. Cookies are sent to your browser from our site and stored on your device’s hard drive to collect information. These data allow us to store your preferences and settings, protect you from fraud, and analyze the performance of our services. You have the right not to provide us with any personal data when you visit the site and may refuse all cookies. However, if you do not accept cookies, you may not be able to use some portions of the site. Cookies stored on your hard drive can be deleted by you at any time through your browser settings. For more detail and information on how to manage cookies, see www.allaboutcookies.org.

Security
Your personal data are important to us. Harmony Biosciences takes several steps to ensure the security of your personal data, but transmission of information over the internet and through electronic storage is not 100% secure. While we use commercially acceptable methods to protect your personal data, we cannot guarantee their absolute security.

Sharing of Information
Other Parties When Required by Law or as Necessary to Protect the Services

While the information you provide will be retained for a commercially reasonable time by Harmony for administrative, liability, and archival purposes, your personally identifying information is not shared with a third party, other than (1) as required by law, (2) to protect and defend the rights of Harmony, the website, or the users of the website, (3) as incident to a corporate sale, merger, reorganization, dissolution, bankruptcy, or similar event, (4) under circumstances we believe reasonably necessary to protect the personal safety of users of the site or its services, or the public, or (5) as is otherwise described in this Privacy Policy.

We may share your information with third-party vendors that perform certain functions or services on our behalf (such as to host the site, manage databases, perform analyses, or send communications). These vendors are required to maintain the confidentiality of user information in accordance with the terms of this Privacy Policy and to otherwise abide by the terms of this Privacy Policy. These vendors are prohibited from using the user information for any other purpose.

Social Networks
You may choose to access or interact with social media websites owned by certain third parties (such as Facebook) through our site. When you choose to link to these websites, you are sharing information with these websites, and the information you share will be governed by their privacy policies. Social media websites may also share information with us and may post information about your visit to our site on their pages. You may be able to modify your privacy settings with these third-party websites.

Third-Party Services
Harmony Biosciences is not responsible for the privacy policies or practices of any third parties, including any third party operating a website or service to which our site links or that provides a link to our site. The inclusion of a link on our site to an external source does not imply our endorsement of the linked website or service. You should review the privacy policies of third-party websites so you can understand how they collect, use, and share your information.

California Privacy Rights
State law permits California residents to annually request and obtain information free of charge about what personal information is disclosed by Harmony to third parties for third-party direct marketing purposes in the preceding calendar year. Harmony does not share information that it collects with third parties for the third party’s direct marketing purposes.

Website Use by Children
This site and its services are not directed toward children under 13 years of age, nor does Harmony Biosciences 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"). If you are under the age of 13, please do not use the site or submit any personal information to us. If you believe that we have unintentionally collected personal information about your child, you can contact us using the information provided below.

Opt Out
You may choose to stop receiving all future email communications from Harmony Biosciences following the unsubscribe instructions on the email communication.

Changes to This Privacy Policy
This Privacy Policy is effective as of October 21, 2019, and will remain in effect except with regard to any changes, which will be in effect immediately after being posted on this page.

Because privacy as it applies to the internet can rapidly change, we may make amendments to this Privacy Policy that affect the use of your personal data. We reserve the right to change the terms of this Privacy Policy at any time by posting revisions to the site. You should periodically review this Privacy Policy for changes. If you do not agree to the terms of this Privacy Policy or revisions to this Privacy Policy, please exit the site immediately.

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INDICATIONS AND USAGE & IMPORTANT SAFETY INFORMATION

  • WAKIX® (pitolisant) is indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

IMPORTANT SAFETY INFORMATION

Contraindications

  • WAKIX is contraindicated in patients with severe hepatic impairment.

Warnings and Precautions

  • WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.
  • The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment (see full prescribing information). WAKIX is not recommended in patients with end-stage renal disease (ESRD).

Adverse Reactions

  • In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.

Drug Interactions

  • Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half.
  • Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required (see full prescribing information).
  • H receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H receptor antagonists.
  • WAKIX is a borderline/weak inducer of CYP3A4. Therefore, reduced effectiveness of sensitive CYP3A4 substrates may occur when used concomitantly with WAKIX. The effectiveness of hormonal contraceptives may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy.

Use in Specific Populations

  • WAKIX may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment.
  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.
  • The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age.
  • WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment.
  • WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with moderate or severe renal impairment.
  • Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers.

Please see the Full Prescribing Information for WAKIX.

To report suspected adverse reactions, contact Harmony Biosciences, LLC at 1-800-833-7460 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.