Injectable peptide to treat acute attacks of hereditary angioedema, a genetic disease that causes sudden swelling of the skin, gut, or throat.
Regulatory status
Approved (FDA / EMA)
Family
Plasma kallikrein inhibitor
Scientific evidence
Moderate
Number of findings
1
Where it acts
Immunity and defense
Also known as
ecallantide, Kalbitor, DX-88
Regulatory status
FDA (U.S.): Approved (2009, Kalbitor) for acute attacks of hereditary angioedema in people aged 12 years and older.
EMA (EU): Not approved: the marketing authorization application was withdrawn in 2011.
Dose
30 mg subcutaneously (three 10 mg injections); it can be repeated once within 24 hours if the attack continues (FDA label 2009).
Safety
Risk of anaphylaxis (boxed warning in the US): it can only be administered by a health professional prepared to treat it. Also headache, nausea, fatigue, diarrhea, and injection-site reactions.
Effect by goal · level of evidence
Acute attacks of hereditary angioedema (EDEMA4)
improvesModerateRCT (AA)in people
Double-blind trial with 72 patients. At 4 hours, symptoms improved more with 30 mg of ecallantide than with placebo (median outcome score 50 vs 0). Time to clear improvement was shorter (about 165 vs more than 240 minutes), although that difference was not significant.
It blocks plasma kallikrein, the enzyme that generates bradykinin. Bradykinin is the substance that dilates blood vessels and causes the swelling in hereditary angioedema.
What the evidence says
In people
Acute attacks of hereditary angioedema (EDEMA4). Double-blind trial with 72 patients. At 4 hours, symptoms improved more with 30 mg of ecallantide than with placebo (median outcome score 50 versus 0). Time to clear improvement was shorter (about 165 versus more than 240 minutes), although that difference was not significant. PubMed 20818887