Welcome to www.veletri.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.veletri.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.veletri.com Terms of Use.
The Information Actelion Collects:
The Way Actelion Uses Information:
When Actelion Discloses Information:
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
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INDICATION
Veletri is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
IMPORTANT SAFETY INFORMATION
Veletri is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction, in patients who develop pulmonary edema during dose initiation, and in patients who have known hypersensitivity to the drug or to structurally related compounds.
Veletri should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension after establishing the diagnosis of idiopathic or heritable PAH or PAH/CTD.
Reconstitute Veletri only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix Veletri with any other parenteral medications or solutions prior to or during administration. Do not abruptly lower the dose or withdraw dosing. All dosing initiation and changes should be closely monitored.
The most common and dose-limiting adverse events during dose initiation and escalation were flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), chest pain (11%), and anxiety (11%).
Adverse events occurring in patients with idiopathic or heritable PAH with =10% difference between epoprostenol and conventional therapy alone were chills/fever/sepsis/flu-like symptoms (25% vs 11%), tachycardia (35% vs 24%), flushing (42% vs 2%), diarrhea (37% vs 6%), nausea/vomiting (67% vs 48%), jaw pain (54% vs 0%), myalgia (44% vs 31%), nonspecific musculoskeletal pain (35% vs 15%), anxiety/nervousness/tremor (21% vs 9%), dizziness (83% vs 70%), headache (83% vs 33%), and hypesthesia/hyperesthesia/paresthesia (12% vs 2%).
Adverse events occurring in patients with PAH/CTD with =10% difference between epoprostenol and conventional therapy alone were flushing (23% vs 0%), hypotension (13% vs 0%), anorexia (66% vs 47%), nausea/vomiting (41% vs 16%), diarrhea (50% vs 5%), jaw pain (75% vs 0%), pain/neck pain/arthralgia (84% vs 65%), headache (46% vs 5%), skin ulcer (39% vs 24%), and eczema/rash/urticaria (25% vs 4%).
Additional reductions in blood pressure may occur when Veletri is administered with diuretics, antihypertensive agents, or other vasodilators. There is the potential for Veletri to increase the risk of bleeding when administered with antiplatelet agents or anticoagulants. Patients on digoxin who receive Veletri may show elevations of digoxin concentration, which may be clinically significant in patients prone to digoxin toxicity.
Please see full Prescribing Information