Before they are used for clinical purposes, every ATGAM lot is passed through tests to make sure that it can inhibit the formation of rosette between red blood cells of sheep and human peripheral lymphocytes in vitro. Antibody activity that’s against the red blood cells of humans and the platelets needs to be measured and it needs to be within the acceptable limits. Only the lots that show negative results for antihuman serum protein antibody, pyrogens, and anti-glomerular basement membrane are allowed for use.
50 mg of horse gamma globulin which is stabilized in 0.3 molar glycine to a pH of around 6.8 is what each millimeter of ATGAM contains.
Indications and Usage
Renal Transplantation ATGAM Sterile Solution is used to manage the rejection of allograft in patients of renal transplants. It’s meant to raise the frequency at which resolution of the acute rejection episode occurs during the rejection phase when it’s administered along with conventional therapy. To delay the start of the first rejection episode, the administration of the drug has been carried out as a supplement with other immunosuppressive therapy. To date, accumulated data haven’t consistently shown any improvement in functional graft survival linked to therapy which can delay the beginning of the initial rejection episode.