The FDA has approved Berinert, a C1-esterase inhibitor, for adolescents and adults with acute abdominal attacks and facial swelling associated with a potentially life-threatening genetic disease, hereditary angioedema (HAE). This protein product is derived from human plasma. Attacks can occur spontaneously or during stress, surgery, or infection in patients with HAE. Berinert regulates clotting and inflammatory reactions that, when impaired, can lead to local tissue swelling.
Berinert is contraindicated in patients with a history of life-threatening hyper sensitivity reactions to C1-esterase inhibitors. Adverse reactions may include subsequent HAE attacks, headache, abdominal pain, nausea, muscle spasms, pain, diarrhea, and vomiting.
Source: FDA, October 12, 2009
