ATryn uses the power of recombinant DNA technology to offer a reliable supply of antithrombin

ATryn is not dependent on the supply of human plasma and contains no preservatives1

The purification and drug manufacturing processes have been validated to demonstrate their capacity for removal and/or inactivation of viruses1

The amino acid sequence of ATryn is identical to that of human plasma–derived antithrombin1

  • The glycosylation profile of ATryn is different from plasma-derived antithrombin (AT), which results in an increased heparin affinity. When assayed in the presence of excess heparin, the potency of ATryn is not different from that of plasma-derived AT1
  • Each single-dose vial of ATryn contains the potency stated on the label, which is approximately 525 IU or 1750 IU1
  • Compared with human plasma–derived AT, the clearance of ATryn is 7 times faster and its half-life is 9 times shorter1

References: 1. ATryn [package insert] Framingham, MA: rEVO Biologics, December 2013.

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effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn.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