Pentaglobin Mechanism of Action

Pharmacotherapeutic group: Immune sera and immunoglobulins: immunoglobulins, human immunoglobulin for intravenous use. ATC code: J06BA02.
Pharmacodynamics: Pentaglobin contains immunoglobulin G (IgG) and elevated concentrations of immunoglobulin A (IgA) and immunoglobulin M (IgM) with a broad spectrum of antibodies to a variety of infectious agents and their toxins.
Pentaglobin contains the antibody spectrum present in the normal population. As a result of its increased concentrations of IgA and in particular IgM, Pentaglobin has higher titres of agglutinating antibodies to bacterial antigens, compared to products that contain only IgG. Pentaglobin is prepared from pooled plasma from at least 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. It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
The half-life of the immunoglobulins contained in Pentaglobin is similar to the half-lives of endogenous immunoglobulins. This half-life may vary from patient to patient, in particular in primary immunodeficiency syndromes.
Immunoglobulins and immunoglobulin complexes are broken down in cells of the reticuloendothelial system.
Toxicology: Preclinical safety data: Immunoglobulins are normal components of the human body. Chronic toxicity and embryofoetal toxicity studies are impracticable due to the induction of, and interference with, antibodies. Effects of the product on the immune system of the neonate have not been studied.
Clinical experience provides no hint for tumorigenic and mutagenic effects. Experimental studies in animals are not considered necessary.