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CSL Behring Study Confirms Early Treatment with Berinert® Provides Faster Resolution of Acute Hereditary Angioedema Symptoms
Date:3/6/2012

n experience episodes of extreme pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.

About Berinert®Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered, plasma-derived intravenous therapy, treats acute facial, abdominal and laryngeal hereditary angioedema (HAE) symptoms by providing C1-INH deficient adult and adolescent patients with the missing human protein. Without C1-INH, people with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues including the face, mouth, throat and abdomen. CSL Behring has marketed its pasteurized and nanofiltered C1-esterase inhibitor concentrate, Berinert, in Germany for more than 30 years. The product is approved and marketed in 23 other European countries, the United States, Australia, Canada, Israel, Argentina, Japan and South Korea.

The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is contraindicated in individuals with a history of life-threatening systemic reactions, to C1 esterase inhibitor preparations, including anaphylaxis. The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. In placebo-controlled clinical trial, dysgeusia was the most common adverse reaction reported in over 4 percent of subjects who received Berinert and more frequently than in placebo group. Thrombotic events have been reported in patients receiving C1 esterase inhibitor product, including Berinert, at the recommended dose as well as when used off-label or at higher-than-labeled doses.

Berinert is derived from human plasma. The risk of transmiss
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