Privacy Policy

Gilead Sciences respects the privacy of our visitors to our Web site. This Privacy Policy is intended to inform you of our policies and practices regarding the collection, use and disclosure of any personal information you submit to us through our Web site. "Personal Information" is information about you that can individually identify you. Examples of Personal Information include your name, address, email address, or phone number and other information that is not otherwise publicly available. This Privacy Policy applies only to information collected by Gilead online through our Web sites, not offline.

User Consent
By submitting Personal Information through our Web site, you agree to the terms of this Privacy Policy.

Anonymous Data
As you navigate our Web site, certain information regarding your use of the Web site will also be automatically collected, including Internet Protocol addresses, cookies and navigational data. This type of information will be used for the purposes of gathering data to provide improved administration of our Web site and to improve the quality of your experience when interacting with our Web site.

Use of Personal Information
Personal Information you submit to us is used either to provide you with information you have specifically requested or to aid us in serving you better. We may use your Personal Information to communicate with you about new products in which you may be interested or about new information regarding our company.

Disclosure of Personal Information
We do not intentionally share your Personal Information with unauthorized third parties. We may share your Personal Information with third party service providers that, for example, administer our email subscriptions and requests for information, or provide services in connection with employment applications.

We cannot fully ensure that your private communications and other Personal Information will not be disclosed to third parties. For example, we may be legally obligated to disclose information to the government or third parties under certain circumstances (such as pursuant to a subpoena), or third parties may circumvent our security measures to unlawfully intercept or access transmissions or private communications. Additionally, in the unlikely event we need to investigate or resolve possible problems or inquiries, we can, and you authorize us to, disclose any information about you to law enforcement or other government officials as we believe necessary.

Regarding Children
Our Web site is not designed for children under the age of 13. We will not deliberately gather Personal Information about visitors in this age group, and do not collect any information on this Web site with respect to age. Gilead abides by the Children's Online Privacy Protection Act in the United States.

Links to Other Sites
Our provision of a link to any other Web site that is not controlled by Gilead is for your convenience and does not signify our endorsement of such other Web site or location or its contents. We have no control over, do not review and cannot be responsible for, these third party Web sites or their content. Please be aware that the terms of our Privacy Policy do not apply to these outside Web sites.

Data Security
When you complete a Medical Information Request Form and subscribe to our product emailing lists, we use industry-standard methods to secure the communication of Personal Information from your computer to our servers. We use industry-standard methods of securing our databases of Personal Information, including the use of firewalls. Except as provided elsewhere in this Privacy Policy, we limit access to Personal Information databases to those persons in our organization who have a business need for such access. However, you should know that no company, including Gilead, can fully eliminate security risks associated with Personal Information.

Privacy Policy Updates
This Privacy Policy is subject to occasional revision, and any changes will be posted on this site. If you object to any such changes, you must cease using our Web site. Continued use of our Web site following notice of any such changes shall indicate your acknowledgement of such changes and agreement to be bound by the terms and conditions of such changes. This policy was last updated August 2004.

Contact Gilead
If you have any queries or complaints about our compliance with this Privacy Policy or if you would like to make any recommendations or comments to improve the quality of our Privacy Policy, please contact the Gilead Public Affairs department.

Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
public_affairs@gilead.com

INDICATION: LETAIRIS is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO Class II or III symptoms to improve exercise capacity and delay clinical worsening.

WARNING: POTENTIAL LIVER INJURY
LETAIRIS (ambrisentan) can cause elevation of liver aminotransferases (ALT and AST) to at least 3 times the upper limit of normal (ULN). LETAIRIS treatment was associated with aminotransferase elevations >3 x ULN in 0.8% of patients in 12-week trials and 2.8% of patients including long-term open-label trials out to one year. One case of aminotransferase elevations >3 x ULN has been accompanied by bilirubin elevations >2 x ULN. Because these changes are a marker for potentially serious liver injury, serum aminotransferase levels (and bilirubin if aminotransferase levels are elevated) must be measured prior to initiation of treatment and then monthly.

In the post-marketing period with another endothelin receptor antagonist (ERA), bosentan, rare cases of unexplained hepatic cirrhosis were reported after prolonged (>12 months) therapy. In at least one case with bosentan, a late presentation (after >20 months of treatment) included pronounced elevations in aminotransferases and bilirubin levels accompanied by non-specific symptoms, all of which resolved slowly over time after discontinuation of the suspect drug. This case reinforces the importance of strict adherence to the monthly monitoring schedule for the duration of treatment.

Elevations in aminotransferases require close attention. LETAIRIS should generally be avoided in patients with elevated aminotransferases (>3 x ULN) at baseline because monitoring liver injury may be more difficult. If liver aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin >2 x ULN, treatment should be stopped. There is no experience with the re-introduction of LETAIRIS in these circumstances.

CONTRAINDICATION: PREGNANCY
LETAIRIS is very likely to produce serious birth defects if used by pregnant women, as this effect has been seen consistently when it is administered to animals [see Contraindications (4.1)]. Pregnancy must therefore be excluded before the initiation of treatment with LETAIRIS and prevented thereafter by the use of at least two reliable methods of contraception unless the patient has had a tubal sterilization or Copper T 380A IUD or LNg 20 IUD inserted, in which case no other contraception is needed. Obtain monthly pregnancy tests.

Because of the risks of liver injury and birth defects, LETAIRIS is available only through a special restricted distribution program called the LETAIRIS Education and Access Program (LEAP), by calling 1-866-664-LEAP (5327). Only prescribers and pharmacies registered with LEAP may prescribe and distribute LETAIRIS. In addition, LETAIRIS may be dispensed only to patients who are enrolled in and meet all conditions of LEAP [see WARNINGS, Prescribing and Distribution Program for LETAIRIS].

Please see full prescribing information, including important safety information and boxed WARNING.