Safety aspects of intravenous immunoglobulins.

Abstract

Seven commercially available intravenous immunoglobulins (IVIG) preparations, a gamma globulin prepared by ethanol fractionation, and an experimental IgG isolated by a chromatographic procedure were compared in several tests. Split products were present in preparations manufactured by procedures involving protease treatment and in a sulphitolysed IgG. The same preparations and another chemically modified product displayed a loss in their capacity to bind staphylococcal protein A. None of the preparations exerted a high anticomplementary activity using concentrated human serum as a complement source. No strict correlation between aggregate content and anticomplementary activity could be established. None of the commercial IVIG preparations tested displayed a sizeable hypotensive action as assessed by a rat model involving potentiation of bradykinin action by an angiotensin convertase inhibitor. The chromatographically purified IgG and an intramuscular IgG prepared by Rivanol fractionation contained high endogenous protease and prekallikrein activator (PKA) activity, respectively and both were found markedly hypotensive. Neither endogenous protease nor PKA activity was detected in the Cohngammaglobulin fraction. However, it was very strongly hypotensive even without any previous blocking of angiotensin convertase. Our data support the view that immunoglobulin preparations may affect blood pressure without inducing bradykinin generation.