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One event of hypersensitivity was reported but the patient continued in the study. No inhibitors have been observed in previously treated patients. CSL Behring is currently conducting an extension study that includes previously untreated patients (PUPs), to determine the safety, my response efficacy and incidence of inhibitors in this high risk population. AFSTYLA is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA, any of its components, or hamster proteins. Precautions for use include hypersensitivity reactions and inhibitors. If available, the chromogenic assay should be used to determine FVIII activity. AFSTYLA is also approved in the European Union, United States, and Canada. About CSL Behring CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.
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