Medication Monitor



Generic Name (Trade Name—Company)
Notes
June 26, 2018

C1 esterase inhibitor (human)

(Cinryze—Shire)
Approval expanded to prevent angioedema attacks in children aged 6 years and older with HAE

Shire announced FDA approval of an expanded indication for C1 esterase inhibitor (human) to prevent angioedema attacks in children aged 6 years and older with hereditary angioedema (HAE). The product has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE.

HAE is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide. The condition results in recurring attacks of edema in various parts of the body, including the abdomen, face, feet, genitals, hands, and throat. The attacks can be debilitating and painful, with those that obstruct the airways potentially life threatening because of the risk of asphyxiation.

The agent is contraindicated in patients who have had life-threatening, immediate hypersensitivity reactions, including anaphylaxis, after using it.

Health professionals are urged to consider treatment methods carefully because hypersensitivity reactions may have symptoms similar to HAE attacks. If an acute severe hypersensitivity reaction occurs, infusion of the product should be discontinued and epinephrine administered.