Gilead Sciences, Inc. ("Gilead") maintains the FLOLAN Web site as a service to the Internet community. The FLOLAN Web site has been designed to provide general information about FLOLAN. These pages are not intended to provide investment or medical advice, nor do they provide instruction on the appropriate use of products produced or supplied under development by Gilead, its affiliates, related companies, or its licensors or joint venture partners. Information on this Web site regarding products approved for marketing is qualified in its entirety by reference to the full prescribing information for products. Users of this Web site should be aware that products under development described herein have not been found safe or effective by any regulatory agency and are not approved for any use outside of clinical trials. Access and use of the FLOLAN Web site is subject to the terms and conditions set forth herein and all applicable laws, statutes, and/or regulations. Gilead may revise these terms and conditions from time to time without further notice by updating this posting. Your access or use of the FLOLAN Web site indicates your acceptance of these terms.
Gilead will use reasonable efforts to include accurate and up-to-date information on the FLOLAN Web site, but all information is provided "AS IS." Gilead makes no warranties or representations as to the accuracy of information presented on the FLOLAN Web site and disclaims all warranties, express or implied, including any warranties of merchantability, fitness for a particular purpose, and non-infringement to the full extent permitted by applicable law. In addition, any information presented on the FLOLAN Web site as of a particular date may only be accurate as of such date and Gilead disclaims any responsibility to update such information. Gilead shall not be held responsible for any action taken that is based on the information presented on the FLOLAN Web site, and all users of the FLOLAN Web site agree that all access and use of the FLOLAN Web site, and any and all content presented on the FLOLAN Web site, is at the user's own risk. Neither Gilead nor any of its agents or affiliates shall be liable for any direct, incidental, consequential, indirect, or punitive damages arising out of user's access, use, or inability to use the FLOLAN Web site, or any errors or omissions in the content of the FLOLAN Web site. FLOLAN communication or material you transmit to Gilead via the FLOLAN Web site or Internet electronic mail is transmitted by you on a nonconfidential basis. Gilead makes no promise, express or implied, not to use such communication or material for any purpose whatsoever, including reproduction, publication, broadcast and posting.
It is the policy of Gilead to enforce its intellectual property rights to the fullest extent permitted under law. The Gilead company name and logo, and all product names, regardless of whether or not they appear in large print or with a trademark symbol, are trademarks of Gilead, its affiliates, related companies, or its licensors or joint venture partners, unless otherwise noted. The entire content of the FLOLAN Web site, including any images or text, is copyrighted and may not be distributed, downloaded, modified, reused, reposted, or otherwise used except as provided herein without the express written permission of Gilead. The use or misuse of these trademarks, copyrights, or other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, communications regulations and statutes, and other laws, statutes and/or regulations.
CONTACT/ADDRESS FOR LEGAL NOTICES
Gilead Sciences, Inc.
Legal Department
333 Lakeside Drive
Foster City, CA 94404
legal_email@gilead.com
INDICATION: FLOLAN is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.
IMPORTANT SAFETY INFORMATION:
Chronic use of FLOLAN is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction.
FLOLAN should not be used chronically in patients who develop pulmonary edema during dose initiation.
FLOLAN must be reconstituted only as directed using STERILE DILUENT for FLOLAN. FLOLAN must not be reconstituted or mixed with any other parenteral medications or solutions prior to or during administration.
Abrupt withdrawal or reductions in delivery of FLOLAN, as well as overdoses, may result in hemodynamic instability, including rebound pulmonary hypertension or fatal hypotension.
FLOLAN should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension.
FLOLAN is a potent inhibitor of platelet aggregation. Therefore, an increased risk for hemorrhagic complications should be considered, particularly for patients with other risk factors for bleeding.
During chronic use, FLOLAN is delivered continuously on an ambulatory basis through a permanent indwelling central venous catheter. Unless contraindicated, anticoagulant therapy should be administered to PPH and PH/SSD patients receiving FLOLAN to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale. In order to reduce the risk of infection, aseptic technique must be used in the reconstitution and administration of FLOLAN as well as in routine catheter care. Dosage of FLOLAN during chronic use should be adjusted at the first sign of recurrence or worsening of symptoms.
Chronic adverse events reported during clinical trials include headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousness.
Serious adverse events have been reported during post-approval use of FLOLAN.
These include sepsis, anemia, hypersplenism, thrombocytopenia, pancytopenia, splenomegaly, and hyperthyroidism.
Excessive doses of FLOLAN may acutely result in systemic hypotension, tachycardia, headache, flushing, nausea and vomiting, diarrhea; excessive doses administered chronically can lead to the development of a hyperdynamic state and high-output cardiac failure.*
*Badesch DB, Abman SH, Ahearn GS, et al. Medical therapy for pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004;126(1, suppl):35S-62S.
Please click here for full prescribing information
