Restoring and maintaining normal antithrombin activity levels during peri-operative or peri-partum periods are linked to reducing VTE risk1,2
The anticoagulant effect of heparin and low molecular weight heparin (LMWH) is enhanced by AT1
- Risk for venous thromboembolism (VTE) is increased by a factor of 10 to 50 in peri-operative and peri-partum patients with hereditary antithrombin (AT) deficiency (HD AT)1 compared to the normal population2 in these situations
- ATryn normalizes and maintains AT activity levels (80%-120%) through continuous dosing, the use of distinct formulae and AT activity monitoring1
Duplex ultrasound was used in the ATryn pivotal trial to confirm occurrence of acute DVT2*
The duplex ultrasound image shown here is not from a patient participating in ATryn clinical studies. This image is for illustration purposes only. Image obtained from Photo Researchers Inc.
- ATryn demonstrated 97% VTE prevention in peri-operative and peri-partum settings2
- – Data were from 2 prospective, single-arm, open-label studies assessing 20 pregnant patients and 11 surgical patients with HD AT (N=31). Patients had AT activity levels ≤60% of normal and a history of thromboembolic events. ATryn was administered as a continuous infusion for at least 3 days, starting 1 day prior to the surgery or delivery.2
- – Efficacy was determined by the incidence of any thromboembolic event from the start of treatment to 7 days after dosing. The occurrence of a VTE was confirmed if signs and symptoms for such events were confirmed by a specific diagnostic assessment or when treatment for an event was initiated based on diagnostic imaging without the presence of signs and symptoms.1,2
- 1 patient had an asymptomatic, acute DVT confirmed by duplex imaging, but the event resolved with continued ATryn therapy plus LMWH and vitamin K antagonists. This patient remained asymptomatic during treatment2
*Duplex ultrasounds were performed and interpreted by qualified specialists within the same hospital/institution on a real-time basis for the timely and appropriate clinical care of the patient. Contrast venography and other scanning techniques could be used, when clinically indicated, if the study investigator felt that duplex ultrasound results were inconclusive or additional tests were appropriate. For purposes of this clinical trial and the primary efficacy endpoint, duplex ultrasound scans were videotaped for a subsequent standardized, blinded interpretation by a qualified, independent laboratory to provide an unbiased evaluation of the incidence of acute DVT. The independent laboratory was provided with videotapes of all scans and no other information about the patient's history or course of treatment.2
References: 1. ATryn [package insert]. Framingham, MA: GTC Biotherapeutics; April 2009. 2. Data on file, GTC Biotherapeutics.
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 download full Prescribing Information for ATryn.
® ATryn is a registered trademark of Lundbeck Inc. in the United States
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