Medical Information

If you are a physician or health care provider and wish to obtain Medical Information about ATryn that is not readily available in the Full Prescribing Information, we ask that you call us at 800-610-3776, send an e-mail to medinfo@revobiologics.com or send your written inquiry by telefax to 877-329-8717. If sending your inquiry via telefax or e-mail, please include your name, address, phone & fax numbers, as well as your e-mail address, along with your written request for information. We will promptly respond to your inquiry.

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effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn.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