Pentaglobin Mechanism of Action

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration. ATC code: J06B A02.
Pharmacology: Pharmacodynamics: Pentaglobin contains immunoglobulin G (IgG) and elevated concentrations of immunoglobulins A (IgA) and M (IgM) having a broad spectrum of antibodies against various infectious agents and their toxins.
Pentaglobin contains the volume of antibodies which is present in the normal population. Because of the raised IgA and especially IgM content Pentaglobin possesses higher titres of agglutinating antibodies to bacterial antigens than pure IgG preparations.
Pentaglobin is prepared from pooled material from not fewer than 1000 donors. Adequate doses of this medicinal product may restore abnormally low immunoglobulin levels to the normal range.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Pharmacokinetics: Human immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration. IgG is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3 to 5 days an equilibrium is reached between the intra- and extravascular compartments.
The half-life of the human immunoglobulins contained in Pentaglobin is comparable to native immunoglobulins. The half-life may vary from patient to patient, in particular in primary immunodeficiency.
Immunoglobulins are broken down in cells of the reticulo-endothelial system.
Toxicology: Preclinical safety data: Immunoglobulins are normal constituents of the human body. In animals, single dose toxicity testing is of no relevance since higher doses result in overloading. Repeated dose toxicity testing and embryo-foetal toxic studies are impracticable due to induction of, and interference with antibodies. Effects of the product on the immune system of the new-born have not been studied.
Since clinical experience provides no hint for tumorigenic and mutagenic effects of immunoglobulins experimental studies, particularly in heterologous species, are not considered necessary.