Approved November 27, 2009

ECALLANTIDE
(FDA Category 1S)

KALBITOR(R) (Dyax Corporation) is a potent, selective, reversible inhibitor of plasma kallikrein which reduces the conversion of high molecular weight kininogen to bradykinin.

DOSING INFORMATION: The recommended dose is 30 mg administered subcutaneously in three 10 mg injections. An additional dose of 30 mg may be given within a 24-hour period if the attack persists.

PHARMACOKINETICS: The Cmax of 586 ng/mL was observed in 2 to 3 hours after a single 30 mg dose given subcutaneously. The mean AUC was 3017 ng x hr/mL. The elimination half-life was 2 hours, plasma clearance was 153 mL/min, and the Vd was 26.4 L. Renal elimination in the urine has been demonstrated.

CAUTIONS: Contraindicated in patients with a known clinical hypersensitivity to ecallantide. Anaphylaxis has occurred, therefore, ecallantide should be administered by a healthcare professional who is aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema. Patients should be monitored closely. Additional adverse events include headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.

FDA APPROVED INDICATIONS: Ecallantide is indicated for the treatment of acute attacks of hereditary angioedema in patients 16 years and older.