An evaluation of the safety of three intravenous immunoglobulin preparations in patients with primary hypogammaglobulinaemia.

In an open study, three different immunoglobulin preparations for intravenous use (IV IgG), namely pH4 and pepsin treated immunoglobulin ('Sandoglobulin'); reduced and alkylated immunoglobulin ('Gamimune') as well as ultrafiltered, pH4 and pepsin treated immunoglobulin manufactured by the Scottish National Blood Transfusion Service ('SNBTS IV IgG'), were compared with intramuscular immunoglobulin (IM IgG) in five patients with primary hypogammaglobulinaemia, by treating each patient consecutively with each immunoglobulin preparation for 3 months. Few adverse reactions were noted with any of the intravenous immunoglobulin preparations and these mainly consisted of mild fever (less than 38 degrees C). Concentrations of serum IgG were higher with all intravenous immunoglobulin preparations compared with IM IgG. Furthermore, all the patients preferred IV to IM IgG therapy. As higher doses of immunoglobulin are associated with a reduction in infections in hypogammaglobulinaemic patients, we conclude that intravenous immunoglobulin therapy should be considered for the prophylaxis of infection in patients with primary hypogammaglobulinaemia.