Safety, efficacy, and pharmacokinetics of Flebogamma® 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseases

The purpose of the study was to evaluate the safety, efficacy, and pharmacokinetics of Flebogamma(R) 5%, an immune globulin intravenous product, for replacement therapy in primary immunodeficient patients. The US Food and Drug Administration has proposed that the use of new products must result in less than or equal to1 serious bacterial infection/subject/year, have acceptable safety and tolerability, and have pharmacokinetic properties similar to endogenous IgG and other commercially available immune globulin products. Flebogamma(R) 5% was administered at seven clinical sites to 51 subjects aged 14-74 years with well-defined primary immunodeficiency diseases at a dose of 300-600 mg/kg every 21-28 days for 12 months. The calculated serious infection rate for the intent-to-treat population was 0.061/subject/year. The incidence of adverse events considered potentially related to Flebogamma(R) 5%, and occurring during or within 72 h after completing the infusion was approximately 8%. The half-life of total IgG was 37 days. Flebogamma(R) 5% is efficacious, safe, and well-tolerated, and does not put subjects at increased risk of adverse events other than those that could be reasonably expected in primary immunodeficient subjects who are receiving any immune globulin product.