ATryn safety profile in clinical trials
The most common adverse events reported in clinical trials of ATryn (≥5%) were hemorrhage and infusion site reaction1
Adverse Reactions in Hereditary AT Deficient Patients
(One Event Per Patient, 2% of Total Population, n=47)1*
| Gastrointestinal Disorders | Intra-abdominal hemorrhage |
| General Disorders and Administration Site Disorders |
Application site pruritis |
| Feeling hot | |
| Noncardiac chest pain | |
| Investigations | Hepatic enzyme abnormal |
| Musculoskeletal and Connective Tissue Disorders |
Hemarthrosis |
| Renal and Urinary Disorders | Hematuria |
| Vascular Disorders | Hematoma |
*Seven patients reported a total of 8 related events,2 as shown in the table.
- No confirmed specific immunological reaction was seen in any of the patients tested, nor were there any clinical adverse events that might indicate such a response1
- The reported rate of adverse events was expected given that these patients (except for those in the PK study) were treated in the peri-operative or peri-partum period2
- Of 47 patients evaluated for safety, 8 related treatment-emergent adverse events were noted in 7 patients, and only 1 (intra-abdominal hemorrhage) was considered to be serious2
- – The intra-abdominal hemorrhage occurred in a pregnant patient who had a cesarean section. This patient was treated and the event resolved without reexploration2
- No adverse events related to ATryn led to study withdrawal2
- All 8 events believed to be related to ATryn were resolved2
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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