Human
immune globulin (
IG) 10 % liquid (
Gammagard Liquid®) is a ready-to-use, highly purified, and concentrated
immunoglobulin (Ig)G
solution approved in the US for both intravenous and subcutaneous antibody replacement
therapy in patients aged ≥ 2 years with primary humoral immunodeficiency.
Intravenous IG 10 % liquid every 3-4 weeks for ≥ 12 months, at median serum
IgG trough levels of 9.6-11.2 g/L, completely prevented acute serious
bacterial infections (SBIs) in a phase III clinical trial. Weekly subcutaneous
IG 10 % liquid at a dose equal to 137 % of the equivalent weekly intravenous dose, which was earlier determined to produce the same
IgG exposure, produced higher serum trough
IgG levels and lower peak
IgG levels than
intravenous administration, and also effectively reduced SBIs; the
infection rate was 0.067 SBIs/subject/year, which met the US FDA efficacy criterion of < 1 SBI/subject/year. The rates for non-serious
infections of any kind were low for both intravenous and subcutaneous
therapy. Both intravenous and subcutaneous
IG 10 % liquid were safe and generally well tolerated. Systemic adverse reactions were more frequent with intravenous
therapy and local
infusion-site reactions were more frequent with subcutaneous
therapy, but the latter reduced over time. Most adverse reactions were of mild or moderate intensity. Thus,
IG 10 % liquid is an effective and generally well-tolerated preparation for both intravenous and subcutaneous
IgG replacement
therapy in patients with
primary immunodeficiency disorders involving antibody deficiency. It offers the benefits of a ready-to-use, liquid preparation and the convenience of home-based
therapy in appropriate patients.