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Background  Hereditary angioedema ( HAE ) is a rare disease caused by  C 1‐esterase inhibitor ( C 1‐ INH ) deficiency, characterized by periodic attacks of acute edema affecting subcutaneous ( SC ) tissues and mucous membranes. Human  C 1‐ INH  concentrate given intravenously ( IV ) is effective and safe, but venous access may be difficult. We compared  SC  and  IV  administration of human pasteurized  C 1‐ INH  concentrate with respect to pharmacokinetics, pharmacodynamics, and safety.    Study Design and Methods  This was a prospective, randomized, open‐label, crossover study. Twenty‐four subjects with mild or moderate  HAE  were randomly assigned during an attack‐free interval to receive 1000 units of human pasteurized  C 1‐ INH  concentrate  IV  or  SC . Plasma levels of  C 1‐ INH  activity and antigen,  C 4 antigen, cleaved high‐molecular‐weight kininogen ( clHK ), and  C 1‐ INH  antibodies were measured.    Results  The mean relative bioavailability of functional  C 1‐ INH  after  SC  administration was 39.7%. Maximum  C 1‐ INH  activity after  SC  administration occurred within 48 hours and persisted longer than after  IV  administration.  C 4 antigen levels increased and  clHK  levels decreased after  IV  and  SC  administration, indicating the pharmacodynamic action of  C 1‐ INH . The mean half‐life of functional  C 1‐ INH  was 62 hours after  IV  administration and 120 hours after  SC  administration (p = 0.0595).  C 1‐ INH  concentrate was safe and well tolerated when administered via both routes. As expected,  SC  administration resulted in a higher incidence of injection site reactions, all of which were mild.    Conclusion  With a relative bioavailability of 39.7%,  SC  administration of human pasteurized  C 1‐ INH  yields potentially clinically relevant and sustained plasma levels of  C 1‐ INH  and is safe and well tolerated.

transfusion

Pharmacokinetics of plasma‐derived  C 1‐esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the  PASSION  study