Privacy Policy

Text

Welcome to www.tracleer.com (or successor URLs) (collectively, the "Site"). Actelion Pharmaceuticals US, Inc. ("Actelion") values your privacy and the privacy of our other customers and visitors of the Site (referred to individually as "User" and collectively as "Users").

This Privacy Policy describes what information we gather from you, how we use that information, and what we do to protect it. By using the Site, you expressly consent to the information handling practices described in this policy.

This Privacy Policy is incorporated into and is subject to the www.tracleer.com Terms of Use. Your use of the Site and any personal information you provide on the Site are subject to the terms of this Privacy Policy and the www.tracleer.com Terms of Use.

The Information Actelion Collects:

User-provided Information: You may provide to Actelion what is generally called "personally identifiable" information (such as your name, email address, postal mailing address, home/mobile telephone number, fax number, credit card number, billing information and the names and email addresses of friends to whom you forward content from the Site) when using the Site. For example, if you use the Site to contact Actelion, we will ask for your email address so that we can respond to you.
"Automatically Collected" Information: When you visit the Site, we may automatically record certain information from your web browser by using different types of technology, including "clear gifs" or "web beacons." This "automatically collected" information may include your Internet Protocol address ("IP Address"), web browser type, the web pages or sites that you visit just before or just after the Site, the pages you view on the Site, and the dates and times that you visit the Site.
Some of the services provided on this website may require registration. When registering with Actelion, you may need to complete certain data fields as well as pick a user name and password. This registration discloses your identity. Please note that in the event you decide to withhold certain requested personal data, it may not be possible for you to access certain parts of the Site.

The Way Actelion Uses Information:

Actelion uses the information you provide or that we collect to operate, maintain, enhance, and provide all of the features and information found on the Site. We will use your email address, without further consent, for administrative purposes, for customer service purposes, to address intellectual property infringement, rights of privacy, or defamation issues.
Actelion uses all of the information that we collect to understand and analyze the usage trends and preferences of our Users, to improve the way the Site works and looks, and to create new features and functionality.
Actelion may use "automatically collected" information to: (a) remember your information so that you will not have to re-enter it during your visit or the next time you visit the Site; and (b) monitor aggregate site usage metrics such as total number of visitors and pages viewed.
Actelion will not use your email address or other personally identifiable information to send promotional messages unless you have opted in or otherwise requested that Actelion contact you about the Actelion products and services or other information. Actelion will not use or disclose the names or email addresses of friends to whom you send content from the Site for any purpose other than sending such content on your behalf upon your initial request.
Actelion prefers that your personal data be updated, accurate and complete. Accordingly, you may access, amend, update and/or request deletion of your personal data at any time. If you wish to access, amend, update or delete your personal data held by Actelion, please contact our Webmaster at the address shown below. Actelion will try to address your request in a prompt and accurate manner and free of charges.

When Actelion Discloses Information:

Actelion does not share your personally identifiable information with other organizations for their marketing or promotional uses without your express consent.
Actelion discloses automatically collected and other aggregate non-personally-identifiable information with interested third parties to assist such parties in understanding the usage, viewing, and demographic patterns for certain programs, content, services, advertisements, promotions, and/or functionality on the Site.
Personal data you provide may incidentally be transferred to a third party acting for or on behalf of Actelion, or in connection with Actelion's business, for further processing in accordance with the original purpose of the collection of the personal data. Such third parties may adopt different private policies. However, Actelion will ask such third parties to provide at least the same degree of protection that Actelion provides. Please note that if you withdraw your consent, Actelion may not be able to comply with some of your requests. Actelion will, where practicable, inform third parties to whom your personal data has been transferred of your withdrawal of consent.
Actelion works with some authorized service providers to provide website hosting and maintenance as well as other services for us. Actelion requires these service providers to safeguard personally identifiable information you provide to us. To the extent it is necessary for these service providers to complete their contractual obligations to Actelion; these third parties may have access to or process your personally identifiable information. Actelion generally limits their use of your personally identifiable information to the purpose for which it was shared.
Actelion may also disclose User information if required to do so by law or in the good-faith belief that such action is necessary to comply with state and federal laws or respond to a court order, judicial or other government subpoena, or warrant. In some cases, we may make such disclosures without first providing notice to Users.
Actelion also reserves the right to disclose User information that we believe, in good faith, is appropriate or necessary to take precautions against liability; protect Actelion from fraudulent, abusive, or unlawful uses; to investigate and defend ourselves against any third-party claims or allegations; to assist government enforcement agencies; to protect the security or integrity of the Site; or to protect the rights, property, or personal safety of Actelion, our Users, or others.

Your Choices:

You may, of course, decline to share your personally-identifiable information with Actelion, in which case Actelion will not be able to provide to you some of the features and functionality found on the Site.

Our Commitment to Children's Privacy:

Protecting the privacy of young children is especially important. For that reason, Actelion does not knowingly collect or maintain personally identifiable information on the Site from persons under 13 years of age, and no part of the Site is directed to persons under 13. IF YOU ARE UNDER 13 YEARS OF AGE, THEN PLEASE DO NOT USE OR ACCESS THE SITE AT ANY TIME OR IN ANY MANNER. If Actelion learns that personally-identifiable information of persons less than 13 years of age has been collected by Actelion without verifiable parental consent, then Actelion will take the appropriate steps to delete this information.

Our Commitment to Data Security:

Actelion uses commercially reasonable physical, managerial, and technical safeguards to preserve the integrity and security of your personal information. We cannot, however, ensure or warrant the security of any information you transmit to Actelion, and you do so at your own risk. Once we receive your transmission of information, Actelion makes commercially reasonable efforts to ensure the security of our systems. However, please note that this is not a guarantee that such information may not be accessed, disclosed, altered, or destroyed by breach of any of our physical, technical, or managerial safeguards.

If Actelion learns of a security systems breach, then we may attempt to notify you electronically so that you can take appropriate protective steps. Actelion may post a notice on the Site if a security breach occurs. Depending on where you live, you may have a legal right to receive notice of a security breach in writing.

International Visitors:

Personally identifiable information collected on the Site may be stored and processed in the United States or any other country in which Actelion or its affiliates, subsidiaries or agents maintain facilities, and by using the Site you consent to any such transfer of information outside of your country.

In the Event of Merger or Sale:

In the event that Actelion is acquired by or merged with a third-party entity, we reserve the right, in any of these circumstances, to transfer or assign the information that we have collected from Users as part of such merger, acquisition, sale, or other change of control.

Changes and Updates to this Privacy Policy:

This Privacy Policy may be revised periodically without further notice to you and this will be reflected by a "last modified" date below. Please revisit this page to stay aware of any changes. In general, we only use your personal information in the manner described in the Privacy Policy in effect when we received that personal information. Your continued use of the Site constitutes your agreement to this Privacy Policy and any future revisions.

For revisions to this Privacy Policy that may be materially less restrictive on our use or disclosure of personal information you have provided to us, we will make reasonable efforts to notify you and obtain your consent before implementing such revisions with respect to such information.

Links to Other Sites:

This website may contain links or references to other websites. Actelion neither controls, endorses, promotes nor has any affiliation with any other site unless expressly stated herein or on such site. You should not assume that the Privacy Policy for this website applies to any of the linked websites. You should therefore read the privacy policy of each linked website that you visit or use.

Effective Date, Date Last Modified:

This Privacy Policy was last modified on April 23, 2010.

Actelion Contact Information:

Please contact Actelion with any questions or comments about this Privacy Policy, your personal information, our third-party disclosure practices, or your consent choices at:

Actelion Pharmaceuticals US, Inc.
c/o Privacy Officer
5000 Shoreline Court, Suite 200
San Francisco, CA 94080

Copyright © 2011 Actelion Pharmaceuticals US, Inc. All rights reserved. The text, images, graphics, sound files, and their arrangement on this website are all subject to copyright and other intellectual property protection. These objects may not be copied for commercial use or distribution, nor may these objects be modified or posted to other sites.

*What is Tracleer?

Tracleer is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs, (WHO Group I). Tracleer can improve your ability to exercise as measured by 6-minute walk test and can slow the worsening of your physical condition and symptoms.

In two different studies, Tracleer improved 6-minute walk distance by 35 and 76 meters. These studies focused on patients with WHO Functional Class III-IV.¹
Clinical worsening was defined as any one of the following: a need to go to the hospital for PAH, stopping treatment because of worsening of PAH, a need for intravenous (IV) treatment (epoprostenol), or death.^2,3

Studies showing Tracleer is effective included mainly patients with NYHA Functional Class II-IV PAH. In these patients, PAH was caused by: unidentified or hereditary factors (60%); connective tissue disease (21%); being born with a hole in the heart between the left and right sides (18%).

In patients with WHO Functional Class II symptoms, Tracleer slowed the worsening of PAH, however, did not show meaningful improvement in walk distance. If you are a patient with WHO Functional Class II symptoms, your healthcare provider will consider whether the potential benefits of Tracleer outweigh the risk of liver damage, which may prevent future use of Tracleer as your disease progresses.

Tracleer is only:

prescribed by healthcare providers who are enrolled in T.A.P.
available to people who understand and agree to enroll in T.A.P.

What is the most important information I should know about Tracleer?

^®

Liver damage:

Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. So you must have a blood test to check your liver function before you start Tracleer and each month after that. Your healthcare provider will order these tests. Regular blood tests are important because they will help your healthcare provider adjust or stop your treatment before there is permanent damage.
Tracleer can cause serious liver damage, including in rare cases liver failure. The contribution of Tracleer in these cases could not be excluded. Even in situations with regular liver testing, rare cases of unexplained liver cirrhosis (scar tissue in the liver) have developed in patients with other medical conditions and taking other medications in addition to Tracleer for over 12 months. Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. Call your healthcare provider right away if you have any of these symptoms of liver problems while taking Tracleer: nausea, vomiting, fever, unusual tiredness, stomach area (abdominal) pain, or yellowing of the skin or the whites of your eyes (jaundice).

Serious birth defects:

Tracleer can cause serious birth defects if taken during pregnancy. You must not be pregnant when you start taking Tracleer or during Tracleer treatment. Serious birth defects from Tracleer can happen early in pregnancy. Females who are able to get pregnant must have a negative pregnancy test before starting treatment and each month during Tracleer treatment.
Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about how to prevent pregnancy. Do not have unprotected sex. Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.
Females who are able to get pregnant must use birth control (contraception) during Tracleer treatment. You must choose and use two reliable forms of birth control at the same time, unless you have had a tubal sterilization, or have a Copper T 380A IUD or LNg-20 IUS. These methods can be used alone.
Talk with your healthcare provider about which 2 methods of reliable birth control you should use. Your healthcare provider may recommend that you use a different method of birth control to help lower your risk of problems with your pulmonary arterial hypertension.

Who should not take Tracleer?

Do not take Tracleer if you:

Are pregnant, plan to become pregnant, or become pregnant during Tracleer treatment. Tracleer can cause serious birth defects. All females should read the birth defects section of "What is the most important information I should know about Tracleer?"
Have a blood test that shows possible liver injury.

Take one of these medicines:

—	Do not take Tracleer with cyclosporine-A, a medication used for psoriasis and rheumatoid arthritis, and to prevent rejection of heart or kidney transplants. Using cyclosporine-A with Tracleer may increase your chance of side effects.
—	Do not take Tracleer with glyburide. Glyburide is used to treat diabetes and when used with Tracleer it may increase your chance of liver injury.

Are allergic to any of the ingredients in Tracleer. If you have a rash, hives or your lips swell after taking Tracleer, it may be a sign of an allergy. You should stop taking your Tracleer and talk to your healthcare provider.

What are the possible side effects of Tracleer?

See "What is the most important information I should know about Tracleer?"
Fluid retention and swelling of ankles and legs. Tracleer can cause your body to hold too much water, and you may get swelling of your ankles and legs. Tell your healthcare provider if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare provider will look for the cause of this.
Lower sperm count. Some men who take Tracleer may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare provider if fertility is a concern for you.
Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with Tracleer.

Call your doctor for medical advice about side effects. You may report side effects to FDA
at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide.

REFERENCES:

TRACLEER^® (bosentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc., February 2011.
Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002;346(12):896-903.
Channick RN, Simonneau G, Sitbon O, et al. Effects of the dual endothelin receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet. 2001;358:1119-1123.

Step Forward with Tracleer

Privacy Policy

REFERENCES: