Comprehensive programs to support patient management
Privacy Policy
PAH Pathways Interactive Resource Locator
PAH Pathways offers a wealth of resources including one-on-one support from PAH Pathways counselors in your area.
Learn more »
Welcome to www.pahpathways.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.pahpathways.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.pahpathways.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 privacy 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 © 2012 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.
Tracleer Indication:
Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital systemic-to-pulmonary shunts (18%).
Considerations for use
Patients with WHO class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these benefits are sufficient to offset the risk of liver injury in WHO class II patients, which may preclude future use as their disease progresses.
Tracleer Important Safety Information:
Because of the risks of liver injury and birth defects, Tracleer may be prescribed and dispensed only through the Tracleer Access Program (T.A.P.), a restricted distribution program, by calling 1-866-228-3546. Only prescribers and pharmacies registered with T.A.P. may prescribe and distribute Tracleer. Tracleer may be dispensed only to patients who are enrolled in and meet all conditions of T.A.P.
Liver injury
Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with Tracleer. In a setting of close monitoring, rare cases of liver failure and unexplained hepatic cirrhosis were observed after prolonged treatment. In general, avoid using Tracleer in patients with elevated aminotransferases (>3 x ULN). Measure liver aminotransferases prior to initiation of treatment and then monthly. Discontinue Tracleer if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2 x ULN.
Teratogenicity
Based on animal data, Tracleer is likely to cause major birth defects if used during pregnancy. Exclude pregnancy before and during treatment. To prevent pregnancy, females of childbearing potential must use 2 reliable forms of contraception during treatment and for 1 month after stopping Tracleer unless the patient has a tubal sterilization or Copper T 380A IUD or LNg 20-IUS inserted, in which case no other contraception is needed. Monthly pregnancy tests should be obtained.
CONTRAINDICATIONS
Tracleer is contraindicated with cyclosporine A, glyburide, in females who are or may become pregnant, or in patients who are hypersensitive to bosentan or any component of Tracleer.
WARNINGS AND PRECAUTIONS
In clinical trials, Tracleer caused ALT/AST elevations (>3 x ULN) in 11% of patients accompanied by elevated bilirubin in a few cases. The combination of hepatocellular injury (increases in aminotransferases of >3 x ULN) and increases in total bilirubin (≥3 x ULN) is a marker for potential serious liver injury. Liver aminotransferase levels must be measured prior to initiation of treatment and then monthly. Avoid using Tracleer in patients with moderate or severe liver impairment or elevated ALT/AST >3 x ULN.
If clinically significant fluid retention develops, with or without associated weight gain, the cause, such as Tracleer or underlying heart failure, must be determined. Patients may require treatment or Tracleer therapy may need to be discontinued.
Preclinical data and an open-label safety study (N=25) showed a decline in sperm count of ≥50% in 25% of Tracleer-treated patients after 3 or 6 months. After 6 months, sperm count remained in normal range, with no changes in sperm morphology or motility, or hormone levels. Endothelin receptor antagonists such as Tracleer may adversely affect spermatogenesis.
Treatment with Tracleer can cause a dose-related decrease in hemoglobin (Hgb) and hematocrit. Hgb should be checked after 1 and 3 months, and then every 3 months. Upon marked decrease in Hgb, determine the cause and need for specific treatment.
If signs of pulmonary edema occur, the possibility of associated pulmonary veno-occlusive disease should be considered. Tracleer should be discontinued.
ADVERSE EVENTS
In Tracleer pivotal trials, the most common adverse events occurring more often in Tracleer-treated patients than in patients taking placebo (≥2%) were respiratory tract infection, edema, hypotension, sinusitis, arthralgia, liver function test abnormal, palpitations, and anemia.
Please see full Prescribing Information, including BOXED WARNING about liver injury and pregnancy.
Ventavis Indication:
Ventavis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue disease (23%).
Ventavis Important Safety Information:
Hypotension leading to syncope has been observed; Ventavis should therefore not be initiated in patients with systolic blood pressure less than 85 mmHg. Stop Ventavis immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension. Ventavis inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive. Serious adverse events reported at a rate of less than 3% included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Vital signs should be monitored while initiating Ventavis. In clinical studies, common adverse reactions due to Ventavis included vasodilation (flushing), cough, headache, trismus, and insomnia. Ventavis has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants.
Please see full Prescribing Information for Ventavis.
