Post-Marketing Registry Study
A post-marketing patient registry has been established to collect additional data on the immunogenic potential of ATryn in patients treated with ATryn on more than one occasion. Physicians are encouraged to participate in the registry by collecting pre- and post-treatment serum samples from patients according to instructions provided by GTC Biotherapeutics, Inc. and submitting them to GTC Biotherapeutics, Inc. for analysis for the development of antibodies to antithrombin (Recombinant). Serum samples should be collected within one week before initiation of treatment and on days 1, 7 and 28 days from initiation of treatment. Physicians wanting to participate in this program are encouraged to contact GTC Biotherapeutics, Inc. at 1-800-610-3776. GTC Biotherapeutics, Inc. will provide free of charge detailed instructions for the collection, processing and shipping of samples, as well as all tubes and labels that are necessary for the collection and processing of samples.
The testing of patient serum samples will be provided free of charge to the physician and patient.
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effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn.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 GTC Biotherapeutics at 1-800-610-3776 or the FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
For more information, please see full Prescribing Information for ATryn.
® ATryn is a registered trademark of GTC Biotherapeutics, Inc.
For medical inquiries, please
call 800-610-3776
or e-mail
medinfo@GTC-bio.com