This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. Select one or more newsletters to continue.

You are encouraged to reportnegative side effects at1-800-455-1141 or to the FDA.Visit www.FDA.gov/MedWatchor call 1-800-FDA-1088. References: 1. The U.S. Food and Drug Administration (FDA) has approved ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. Framingham, MA: GTC Biotherapeutics; April 2009. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis, and post procedural).

See full prescribing information for ATryn.

For more information, please download full Prescribing Information for ATryn. ATryn is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S. People with hereditary antithrombin deficiency are at increased risk f… Treatment for: Prevention of Peri-Operative and Peri-Partum Thromboembolic Events in Hereditary Antithrombin Deficient Patients. The safety and efficacy of ATryn was established in clinical studies conducted in hereditary antithrombin deficient patients with a history of thromboembolic events in the U.S., Europe and Canada. 2.

Treatment goal is to restore and maintain functional antithrombin (AT) activity levels between 80% - 120% (0.8 - 1.2 IU/mL) of normal.

For medical inquiries, please

Editor's note: We're posting this story from our September 2006 issue because of recent FDA action on ATryn..

Anaphylaxis and severe hypersensitivity reactions are possible. ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

Known hypersensitivity to goat and goat milk proteins. 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. ATryn contains recombinant human antithrombin (rhAT), purified from the milk of transgenic goats. Antithrombin (AT) is a serine protease inhibitor that is the principal inhibitor of the blood coagulation serine proteases thrombin and Factor Xa, and to a lesser …

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ATryn [package insert]. ATryn is a sterile lyophilized powder for reconstitution. Echelard Y, Meade HM, Ziomek CA. It is for patients who have a rare disease known as antithrombin (AT) deficiency. Post-marketing studies will be performed to assess safety and immunogenicity after repeat dosing. Available for Android and iOS devices. Modern Biopharmaceuticals. ATryn is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S. People with hereditary antithrombin deficiency are at increased risk for venous thromboembolic events, including pulmonary embolism and deep vein thrombosis, which can be life-threatening, particularly in high risk situations.

Generic Name: Antithrombin [Recombinant] It is not indicated for treatment of thromboembolic events in hereditary antothrombin deficient patients. The first-generation founder goats were then bred to give rise to female “production” goats, which serve as the main sources of Atryn. The most common adverse events reported in clinical trials at a frequency of = 5% are hemorrhage and infusion site reaction. The U.S. Food and Drug Administration (FDA) has approved ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

Date of Approval: February 6, 2009 The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural).

New Antithrombin Drug, ATryn, Approved by FDA ATryn, an anticoagulant, is the first ever biologic product produced by a genetically engineered (GE) animal – a goat.

Discard any unused portion. During these studies, ATryn was shown to prevent the formation of clinically overt thromboembolic events.

Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis and to notify their health care provider immediately if these events develop. 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. ® Trademark of GTC Biotherapeutics, Inc in the United States. If these reactions occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.

To report suspected adverse reactions, contact Ovation Pharmaceuticals at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ATryn is produced through transgenic, recombinant technology—independent of the supply of human plasma, with no preservatives.1, ATryn provides a homogeneous, well-defined, and abundant supply of antithrombin with distinct dosing forumlae.1,2. AT activity monitoring is required for proper treatment. Company: GTC Biotherapeutics Indications and Usage: The most common adverse events reported in clinical trials at a frequency of ≥5% are hemorrhage and infusion site reaction. ATryn enhances anticoagulant effect of heparin and low molecular weight heparin. ATryn is an anticoagulant (anti thrombin) produced by genetically engineered goats (transgenic goats expressing the human anti thrombin gene) in their milk. 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. The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. Allergic-type hypersensitivity reactions, including anaphylaxis are possible. 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. The half-life of ATryn may be altered by concomitant treatment with anticoagulants that use antithrombin to exert their anticoagulant effect.

Most common adverse reactions reported in clinical trials at a frequency of = 5% were hemorrhage and infusion site reaction.

The dosage of ATryn is individualized for each patient.

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