TAKE THE FIRST STEP FORWARD TO A SOLID FOUNDATION WITH ADCIRCA® (tadalafil)

A first-line PDE-5 inhibitor that can help improve exercise ability

ADCIRCA® (tadalafil) is a phosphodiesterase 5 inhibitor (PDE-5i) 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 II–III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
For US Healthcare Professionals Only

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 Lung Biotechnology Inc Web site. Lung Biotechnology Inc and its affiliates also operate other Web sites. This Privacy Statement does not apply to the other Lung Biotechnology Inc Web sites. You should review the privacy statement posted on other Lung Biotechnology Inc 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 Terms of Use are the complete agreement between you and Lung Biotechnology Inc 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. Lung Biotechnology Inc 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 Lung Biotechnology Inc 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 Lung Biotechnology Inc.

HOW DOES Lung Biotechnology Inc KEEP AND USE PERSONAL INFORMATION?
Please note, Lung Biotechnology Inc 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 ADCIRCA.com, you are giving Lung Biotechnology Inc 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 Lung Biotechnology Inc products.

Your password will be used to keep your information secure and help us build your personalized Web page when you login.

DOES Lung Biotechnology Inc EVER SHARE PERSONAL INFORMATION WITH THIRD PARTIES?
Lung Biotechnology Inc 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. Lung Biotechnology Inc 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 Lung Biotechnology Inc, 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 Lung Biotechnology Inc. 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 Lung Biotechnology Inc 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 Lung Biotechnology Inc.
If you have questions or comments about this Privacy Statement, please contact:
Office of General Counsel
Lung Biotechnology Inc/United Therapeutics
legal@unither.com

Important Safety Information for ADCIRCA® (tadalafil) tablets

CONTRAINDICATIONS

  • Nitrates: ADCIRCA should not be used in patients taking medicines that contain nitrates, as the combination could cause a sudden, unsafe drop in blood pressure
  • Hypersensitivity Reactions: Patients with a known serious hypersensitivity to tadalafil should not take ADCIRCA

WARNINGS AND PRECAUTIONS

  • Cardiovascular: Patients who experience anginal chest pain after taking ADCIRCA should seek immediate medical attention
  • Cardiovascular: Phosphodiesterase 5 inhibitors (PDE-5is), including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such actions. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of ADCIRCA to these patients is not recommended
  • Cardiovascular: The use of ADCIRCA with alpha blockers, blood pressure medications, or alcohol may lower blood pressure significantly and may lead to symptomatic hypotension (light-headedness or fainting)
  • Potential Drug Interactions: Tadalafil is metabolized predominately by CYP3A in the liver. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, ADCIRCA should be discontinued at least 24 hours prior to starting ritonavir. For patients on ritonavir therapy that require treatment with ADCIRCA, start ADCIRCA at 20 mg once a day. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided
  • Special Populations: The use of ADCIRCA is not recommended for patients with severe renal or hepatic impairment. Please see Full Prescribing Information for dosing recommendations for patients with mild to moderate renal or hepatic impairment
  • Potential Drug Interactions: ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED) and the signs and symptoms of benign prostatic hyperplasia (BPH). The safety and efficacy of combinations of ADCIRCA with Cialis or other PDE-5is have not been studied. Therefore, the use of such combinations is not recommended
  • Vision/Hearing: Patients who experience a sudden loss of vision in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), or sudden decrease or loss of hearing after taking ADCIRCA should seek immediate medical attention
  • Prolonged Erection: In rare instances, men taking PDE-5is (including tadalafil) for ED reported an erection lasting more than four hours. Male patients who experience a prolonged erection should seek immediate medical attention

ADVERSE REACTIONS

  • Adverse Reactions: The most common adverse event with ADCIRCA is headache (42% ADCIRCA vs 15% placebo). Other common adverse events (reported by ≥9% of patients on ADCIRCA and more frequent than placebo by 2%) include myalgia (14% vs 4%), nasopharyngitis (13% vs 7%), flushing (13% vs 2%), respiratory tract infection (13% vs 6%), extremity pain (11% vs 2%), nausea (11% vs 6%), back pain (10% vs 6%), dyspepsia (10% vs 2%), and nasal congestion (9% vs 1%)

ISI.HCP.KCGLUNGLLC-4-70.v1

For more information about ADCIRCA, please see the Full Prescribing Information and
Patient Information or call 1-800-545-5979.

HOW ADCIRCA WORKSPATIENT ASSISTANCEREGISTER FOR SITE UPDATES

Important Safety Information for ADCIRCA® (tadalafil) tablets

CONTRAINDICATIONS

  • Nitrates: ADCIRCA should not be used in patients taking medicines that contain nitrates, as the combination could cause a sudden, unsafe drop in blood pressure
  • Hypersensitivity Reactions: Patients with a known serious hypersensitivity to tadalafil should not take ADCIRCA

WARNINGS AND PRECAUTIONS

  • Cardiovascular: Patients who experience anginal chest pain after taking ADCIRCA should seek immediate medical attention
  • Cardiovascular: Phosphodiesterase 5 inhibitors (PDE-5is), including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such actions. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of ADCIRCA to these patients is not recommended
  • Cardiovascular: The use of ADCIRCA with alpha blockers, blood pressure medications, or alcohol may lower blood pressure significantly and may lead to symptomatic hypotension (light-headedness or fainting)
  • Potential Drug Interactions: Tadalafil is metabolized predominately by CYP3A in the liver. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, ADCIRCA should be discontinued at least 24 hours prior to starting ritonavir. For patients on ritonavir therapy that require treatment with ADCIRCA, start ADCIRCA at 20 mg once a day. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided
  • Special Populations: The use of ADCIRCA is not recommended for patients with severe renal or hepatic impairment. Please see Full Prescribing Information for dosing recommendations for patients with mild to moderate renal or hepatic impairment
  • Potential Drug Interactions: ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED) and the signs and symptoms of benign prostatic hyperplasia (BPH). The safety and efficacy of combinations of ADCIRCA with Cialis or other PDE-5is have not been studied. Therefore, the use of such combinations is not recommended
  • Vision/Hearing: Patients who experience a sudden loss of vision in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), or sudden decrease or loss of hearing after taking ADCIRCA should seek immediate medical attention
  • Prolonged Erection: In rare instances, men taking PDE-5is (including tadalafil) for ED reported an erection lasting more than four hours. Male patients who experience a prolonged erection should seek immediate medical attention

ADVERSE REACTIONS

  • Adverse Reactions: The most common adverse event with ADCIRCA is headache (42% ADCIRCA vs 15% placebo). Other common adverse events (reported by ≥9% of patients on ADCIRCA and more frequent than placebo by 2%) include myalgia (14% vs 4%), nasopharyngitis (13% vs 7%), flushing (13% vs 2%), respiratory tract infection (13% vs 6%), extremity pain (11% vs 2%), nausea (11% vs 6%), back pain (10% vs 6%), dyspepsia (10% vs 2%), and nasal congestion (9% vs 1%)

ISI.HCP.KCGLUNGLLC-4-70.v1


For more information about ADCIRCA, please see the Full Prescribing Information and
Patient Information or call 1-800-545-5979.

-Thomas A Gieseke - 3 illustrations for Adcirca: pillbox with empty "Sunday" compartment, isolated dog and isolated pedometer. Indefinite buyout of rights for use in print and electronic media (iPad presentation) for use by Adcirca only -Copyright Clearance Center - Wolters Kluwer Health, Circulation, Nazzareno Galie, Bruce H. Brundage, Hossein A. Ghofrani, Ronald J. Oudiz, Gerald Simmonneau, Zeenat Safdar, Shelley Shapiro..., Tadalafil Therapy for Pulmonary Arterial Hypertension, License No: 3177700012726 -Nicholais Photography - Unlimited use of photos in print, digital, web for pro and consumer in the US -Bella Agency - Victoria Gardner, unlimited use in print, digital and web