INHALEABLE

Important Safety Information Full Prescribing Information Patient Package Insert Instructions For Use

Privacy Policy

PLEASE READ THIS PRIVACY STATEMENT CAREFULLY. Privacy is very important to us. We also understand that privacy is very important to you. This Privacy Statement tells you how we protect and use information that we gather through this United Therapeutics Corporation Web site. United Therapeutics Corporation and its affiliates also operate other Web sites. This Privacy Statement does not apply to the other United Therapeutics Corporation Web sites. You should review the privacy statement posted on other United Therapeutics Corporation Web sites when you visit them. This Web site and this Privacy Statement are intended only for audiences in the U.S.

This Privacy Statement was last revised on June 19, 2009. We may change this Privacy Statement at any time and for any reason. Significant changes to the Privacy Statement are discussed below in the Section called "Changes to the Privacy Statement." We encourage you to review this Privacy Statement each time you visit the Web site.

By using this Web site, you agree to the terms of the most recent version of this Privacy Statement. Please read our Terms of Use to understand the general rules about your use of this Web site. Except as written in any other disclaimers, policies, Terms of Use, or other notices on this Web site, this Privacy Statement and the Term of Use are the complete agreement between you and United Therapeutics Corporation with respect to your use of this Web site.

INTRODUCTION

We are pleased to post this policy so that users understand how we utilize the information they provide us. For other important information concerning your use of our site, please refer to our Terms of Use. United Therapeutics Corporation respects the privacy of those who use its site. Users should understand, however, that by the very nature of the medium, their communications with us, such as postings to the site or e-mail, reveal their e-mail addresses and other potentially identifying information. The information we receive, and how we use it, depends on what you do when visiting our Web site. We collect and use your non-personal information (information that is not identifiable to you personally) differently than your personal information.

WHAT IS NON-PERSONAL INFORMATION?

Non-personal information is information we collect through this Web site that does not identify you as an individual person. It includes any of the following items:

  • the type of Web browser software you use (for example, Netscape Navigator or Internet Explorer)
  • the name of the domain from which you access the Internet (including client and server IP addresses, usernames, ports, queries, or other status-related information);
  • the Internet address of the Web site from which you linked directly to our Web site;
  • the date and time you access our Web site;
  • which pages you have visited on our Web site

WHAT DOES UNITED THERAPEUTICS CORPORATION DO WITH NON-PERSONAL INFORMATION?

Because non-personal information cannot identify you or be tied to you in any way, there are few restrictions on the ways that we can use or share non-personal information. Primarily, we will use this data to make enhancements to the Web site that are specifically tailored to improve the experience of the user community. One way that we use non-personal information is to demonstrate user trends on the Web site. Often, this is done by aggregating the data gleaned from non-personal information. This aggregated, de-identified data might be shared with outside parties who are employed to implement improvements to the site.

WHAT IS PERSONAL INFORMATION?

Personal information is information we collect through this Web site that we can use to specifically identify you, such as your:

  • name
  • telephone number
  • e-mail address
  • state of residence
  • age range
  • gender
  • name of your physician
  • whether you are a patient or caregiver
  • why you are participating in the program

In some places on this Web site you have the opportunity to send us personal information about yourself. For example, you may fill out a registration form, a survey, or an email form.

Any personal information that you enter on this Web site will not be revealed to third parties or used for any purpose outside of United Therapeutics Corporation.

HOW DOES UNITED THERAPEUTICS CORPORATION KEEP AND USE PERSONAL INFORMATION?

Please note, United Therapeutics Corporation and its agents comply with HIPAA (Health Information Portability and Accountability Act) in the collection and use of your personally identifiable health information. When you register on Tyvaso.com, you are giving United Therapeutics Corporation permission to use your personal information to communicate with you. Your information will never be shared with a third party, except as outlined below.

We may keep and use personal information we collect from you through this Web site to provide you with access to this Web site. In addition, we may keep and use your personal information:

  • to send you information you requested
  • to respond to your requests
  • to develop records, including records of your personal information
  • for internal program monitoring—never for personal reporting purposes
  • to remove your personal identifiers (your name, e-mail address, etc). In this case, you would no longer be identified as a single unique individual. Once we have de-identified information, it is non-personal information and we may treat it like other non-personal information.
  • to enforce this Privacy Statement and other rules about your use of this Web site
  • to protect our rights or property
  • to protect someone's health, safety, or welfare
  • to comply with a law or regulation, court order or other legal process

How the Information is Used

We respect the information you submit. Your information will be used only for internal program monitoring. We will not use, sell, or assign your e-mail address for any purpose other than to communicate with you about United Therapeutics Corporation products. Your password will be used to keep your information secure and help us build your personalized Web page when you login.

DOES UNITED THERAPEUTICS CORPORATION EVER SHARE PERSONAL INFORMATION WITH THIRD PARTIES?

United Therapeutics Corporation will not share your personal information collected from this Web site with an unrelated third party without your permission.

In the ordinary course of business, we will share some personal information with companies that we hire to perform services or functions on our behalf. For example, we employ a company to develop and maintain this Web site. In this case, the company will have access to your personal information in the ordinary course of business. However, in this instance, and all instances in which your personal information is shared with a third party, we will not authorize them to keep, disclose, or use your information with others except for the purpose of providing the services we asked them to provide.

We will not sell, exchange, or publish your personal information, except in conjunction with a corporate sale, merger, dissolution, or acquisition.

We may be legally compelled to release your personal information in response to a court order, subpoena, search warrant, law, or regulation. We may cooperate with law enforcement authorities in investigating and prosecuting Web site visitors who violate our rules or engage in behavior which is harmful to other visitors (or illegal).

We may disclose your personal information to third parties if we feel that the disclosure is necessary to:

  • enforce this Privacy Statement and the other rules about your use of this Web site
  • protect our rights or property
  • protect someone's health, safety, or welfare
  • comply with a law or regulation, court order, or other legal process

Please note: In addition to the ways that we may keep, disclose, and use information described in this Privacy Statement, we also may keep, disclose, and use personally identifiable information that you give us through this Web site in ways that we believe are consistent with FDA and other governmental guidance, directions, regulations, and laws.

WHAT HAPPENS IF THE PRIVACY STATEMENT CHANGES?

If we decide to make a significant change to our Privacy Statement, we will post a notice on the homepage of our Web site for thirty (30) days after the change is made. United Therapeutics Corporation reserves the right to change the terms of our Privacy Statement at any time in its sole discretion. Please periodically revisit this page to stay current on any changes and to update your preferences accordingly.

WHAT ABOUT PRIVACY ON OTHER WEB SITES?

This Web site may contain links to other Web sites. Some of those Web sites may be operated by United Therapeutics Corporation, and some may be operated by third parties. We provide the links for your convenience, but we do not review, control, or monitor the activities or privacy practices of Web sites operated by others, and we do not endorse, condone, adopt, or accept liability for any statements made on Web sites to which we provide links. This Privacy Statement does not apply to any other Web site, even those owned by United Therapeutics Corporation. We are not responsible for the performance of Web sites operated by third parties or for your business dealings with them. Therefore, whenever you leave this Web site, we recommend that you review each Web site's privacy practices and make your own conclusions regarding the adequacy of these practices.

DOES UNITED THERAPEUTICS CORPORATION EVER COMMUNICATE DIRECTLY WITH VISITORS TO THIS WEB SITE?

With your express permission, we may contact you periodically by e-mail, mail, or telephone to provide information regarding programs, services and content that may be of interest to you. In addition, some of the features on this Web site allow you to communicate with us using an online form. If your communication requests a response from us, we will send you a response via e-mail. The e-mail response or confirmation may include your personal information, including personal information about your health, your name, address, etc. We cannot guarantee that our e-mails to you will be secure from unauthorized interception.

ARE THERE SPECIAL RULES ABOUT CHILDREN'S PRIVACY?

We care about protecting the online privacy of children. This Web site is not intended for use by children under the age of 18. We will not intentionally collect any personal information (such as a child's name or e-mail address) from children under the age of 18. If you are a child under age 18, please do not send us any information about yourself. If you think that we have collected personal information from a child under the age of 18, please contact us. We encourage all parents and guardians to monitor their children’s use of the internet.

WHAT ABOUT WEB SITE SECURITY?

We take reasonable steps to protect your personal information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from this site may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail.

HOW TO CONTACT UNITED THERAPEUTICS CORPORATION.

If you have questions or comments about this Privacy Statement, please contact:

Alyssa Friedrich
Senior Vice President, Human Resources & Corporate Development
United Therapeutics Corporation
afriedrich@unither.com

Indication

Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.

Important Safety Information for Tyvaso

  • Tyvaso is intended for oral inhalation only. Tyvaso is approved for use only with the Tyvaso Inhalation System
  • The safety and efficacy of Tyvaso have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age. Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect
  • Tyvaso may increase the risk of bleeding, particularly in patients receiving anticoagulants
  • In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension. The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension
  • Hepatic or renal insufficiency may increase exposure to Tyvaso and decrease tolerability. Tyvaso dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn
  • The most common adverse events seen with Tyvaso in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%)
  • Tyvaso should be used in pregnancy only if clearly needed. Caution should be exercised when Tyvaso is administered to nursing women

For more information about Tyvaso, please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use Manual. Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).

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