PHARMACOKINETIC CHARACTERISTICS AND TOLERABILITY OF A NOVEL INTRAVENOUS IMMUNOGLOBULIN PREPARATION

In two independent trials 10 and 12 healthy volunteers received the no vel intravenous immunoglobulin (IVIG) preparations BT 511 and BT 507, respectively. BT 511 contains 5 g human plasma proteins per 100 ml, mo re than 95% of which are immunoglobulins of the G class (IgG). BT 507 contains in addition 61 IU antibody against hepatitis B surface antige n (anti-HBs). ml(-1). In trial I volunteers received 4.0 ml/kg: (n = 4 ) and 8.0 ml . kg(-1) (n = 6) BT 511 to study the tolerability and the magnitude of the increase in immunoglobulins in plasma as well as the ir decline over 1 month. After administration of the lower dose, plasm a IgG increased from 10.7 to 14.7 g . l(-1) directly after the infusio n. Following the 8.0 ml kg-l dose a more pronounced increase from 12.4 to 21.2 g . l(-1) was observed. No adverse events occurred. After 1 m onth IgG concentrations had almost reached baseline values at 12.2 g . l(-1) in the 4.0 ml . kg(-1) group, but were still significantly incr eased at 15.2 g . l(-1) after the high dose. There was a linear correl ation between the maximal IgG plasma concentration and the subsequent decline of IgG during the 29-day observation period. After administrat ion of BT 507 maximal anti-HBs concentrations of 1778 mU . ml(-1) occu rred 1.4 h after termination of the infusion. The terminal elimination half-life was 22.4 days, and total clearance and volume of distributi on were determined to be 0.122 ml . min(-1) and 5.41, respectively. Th e pharmacokinetic parameters calculated for anti-HBs as an indicator o f IgG were in accordance with the pharmacokinetic behaviour of native IgG.