The most common adverse reactions in clinical trials associated with Cinryze were rash, headache, nausea, and vomiting. Adverse events of sinusitis and upper respiratory infection also were observed in clinical trials. There were no serious adverse reactions in the randomized, placebo controlled crossover routine prophylaxis study. The only serious adverse reaction observed in clinical studies of Cinryze was cerebrovascular accident. Please visit http://www.viropharma.com/products/cinryze.aspx for the full U.S. Prescribing Information; the prescribing information for other countries can be found at www.viropharma.com.
About Hereditary Angioedema (HAE)
HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unregulated, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Patients with HAE experience approximately 20 to 100 days of incapacitation per year. There are estimated to be at least 6,500 people with HAE in the United States and at least 10,000 people in the European Union.
For more information on HAE, visit the U.S. HAE Association's website at
www.haea.org and the HAEi's (International Patient Organization for C1 Inhibitor Deficiencies) website at
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