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ATryn®, a recombinant form of human antithrombin, also known as ATIII, is at the forefront of transgenic technology for the production of biotherapeutics. Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties that, like many other therapeutic proteins which are currently derived from the human blood supply, has been difficult to express using conventional recombinant protein production methods.
In the United States the Food and Drug Administration (FDA) approved ATryn® for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient, or HD, patients. ATryn® is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S.
In August of 2006, following a positive opinion by the CHMP, the European Commission approved ATryn® for treatment of patients with hereditary antithrombin deficiency, undergoing high-risk surgical or childbirth procedures.
ATryn uses recombinant 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 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: GTC Biotherapeutics; April 2009.
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.
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