Cytomegalovirus immunoglobulin

Cytomegalovirus immunoglobulin is used as a CMV-specific polyclonal immunoglobulin preparation that binds to CMV surface antigens thereby neutralizing the potential of CMV from entering host cells and presenting the CMV particle for phagocytosis. Cytomegalovirus immunoglobulin antibodies also modulate and interact with immune cells (dendritic cells, monocytes, B- and T-cells) exerting a positive immunological balance in addition to the virostatic inhibition of CMV replication.

Pharmacodynamic effects

The primary mode of action of cytomegalovirus immunoglobulin is the binding of circulating virus. These CMV-specific antibodies block the infection of different cell types including all CMV genotypes and of virus variants that are resistant to virostatics. Furthermore, cytomegalovirus immunoglobulin can activate CMV-reactive immune cells for long-lasting CMV-specific immune responses. It also has additional immunomodulating properties independent of CMV that have been implicated with a reduction of organ rejection.

Cytomegalovirus immunoglobulin is immediately and completely bioavailable in the recipient’s circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid; after approximately 3-5 days an equilibrium is reached between the intra- and extravascular compartments.

Cytomegalovirus immunoglobulin has a half-life of 25 days. This half-life may vary from patient to patient and depends also on the clinical condition.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

Immunoglobulins are normal constituents of the human body. Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.

Since clinical experience provides no hint for tumorigenic and mutagenic effects of immunoglobulins, experimental studies, particularly in heterologous species, are not considered necessary.