Terms of Use

These Terms of Use apply to any web site operated or controlled by rEVO Biologics, Inc. (hereinafter collectively referred to as the "Sites"). Sites as used in this Terms of Use, "You" or "Your" refers to visitors and users of this Sites. "We", "Us" or "rEVO" includes rEVO Biologics, ("rEVO") and its related companies, as well as any third-party vendors We hire to assist directly in the administration of these Sites.

Binding Agreement

By using the Sites and accessing information on the Sites, You acknowledge that You have read, understood and agree to be bound by the following Terms of Use and all applicable local, state and Federal laws, rules and regulations. If You do not agree to these Terms of Use, You are not permitted to use the Sites.

Special Note to Our Visitors

The Sites do NOT provide any medi cal advice, diagnosis, or treatment. If You need medical advice, diagnosis, or treatment, please see a physician and do NOT use the Sites for that purpose. Further, rEVO does not and cannot recommend treatment or offer medical advice on personal health matters. The contents contained herein, including but not limited to all product information, is for informational purposes only and is not intended, nor should it be used, as a substitute for professional medical advice, diagnosis or treatment. rEVO does not recommend or endorse any specific tests, products, procedures, opinions, or other information that may be mentioned on the Sites. The contents on these Sites shall not be used as a substitute for professional diagnosis or treatment. Further, Your access to or use of the Sites does not create in any way a physician-patient relationship, any sort of confidential relationship, or any other relationship that would give rise to any duties on the part of rEVO, its agents or employees. Always seek the advice of a qualified healthcare professional with any questions You may have regarding any medical condition. Never disregard medical advice or delay in seeking medical advice because of something You have read on these Sites. If there is an emergency, dial 911.

While We make reasonable efforts to ensure the information provided on the Sites is accurate, We make no warranties about the accuracy and reliability of the information, data or content on the Sites. We shall not be responsible or liable for the accuracy, usefulness or availability of any information transmitted or made available via the Sites. Neither rEVO nor any source that may provide Us with information for these Sites is directly or indirectly responsible for practicing medicine, dispensing medical services, or providing treatments as part of the Sites. These Sites are provided "AS IS" without warranty, express or implied. See the Disclaimer of Warranties Section below for more details.

Proper Use of the Sites

You agree that You will use the Sites in compliance with all applicable local, state and federal laws, rules and regulations. Violation of any of the foregoing or of these Terms of Use may result in immediate termination of these Terms of Use and may subject You to state and federal penalties and other legal consequences. We reserve the right, but shall have no obligation, to investigate Your use of the Sites in order to (a) determine whether a violation of these Terms of Use has occurred or (b) comply with any applicable law, regulation, legal process or governmental request.

You may not use the Sites in any manner that could damage, disable, overburden, or impair our servers or networks, or interfere with any other party's use and enjoyment of the Sites. You may not attempt to gain unauthorized access to any services, user accounts, computer systems or networks, through hacking, password mining or any other means. We may take any legal and technical remedies to prevent the violation of this provision and to enforce these Terms of Use.

Certain parts of the Sites may require a password to enter. You agree that You are responsible for all acts or omissions that occur on Your account while Your password is being used. If You believe someone has used Your password or account without Your authorization, You must notify us immediately. We reserve the right to access and disclose any information, including, without limitation, user names of accounts and other information, to comply with applicable laws and lawful government requests.

Indications and Usage

ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.

 

Important Safety Information

ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis, are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.

The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals, and in particular in the first hours following the start or withdrawal of ATryn. Additionally, patients should be monitored for the occurrence of bleeding or thrombosis in such situations.

The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis, and post procedural). The most common adverse events reported in clinical trials at a frequency of
≥ 5% are hemorrhage and infusion site reaction.

For more information, please view full Prescribing Information for ATryn.

To report suspected adverse reactions contact rEVO Biologics at 800-610-3776 or the FDA at 800-FDA-1088 or www.fda.gov/MedWatch.

For more information, please see full Prescribing Information for ATryn.

® ATryn is a registered trademark of rEVO Biologics, Inc.
rEVO Biologics is a registered trademark of LFB S.A.

link to gtc-bio.com

For medical inquiries, please
call 800-610-3776
or e-mail
medinfo@revobiologics.com