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
Non-cardiac chest pain
Investigations Hepatic enzyme abnormal
Musculoskeletal and
Connective Tissue Disorders
Hemarthrosis
Renal and Urinary Disorders Hematuria
Vascular Disorders Hematoma
  • 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

References: 1. ATryn [package insert] Framingham, MA: rEVO Biologics, December 2013.

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effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn.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 rEVO Biologics at 800-610-3776 or the FDA at 800-FDA-1088 or www.fda.gov/MedWatch.

For more information, please see full Prescribing Information for ATryn.

® ATryn is a registered trademark of rEVO Biologics, Inc.
rEVO Biologics is a registered trademark of LFB S.A.

link to gtc-bio.com

For medical inquiries, please
call 800-610-3776
or e-mail
medinfo@revobiologics.com