IMMUNOHBs Mechanism of Action

Pharmacotherapeutic Group: Immune sera and immunoglobulins. Human hepatitis B immunoglobulin. ATC Code: J06BB04.
Pharmacology: Pharmacodynamics: Human hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
A study carried out in HBsAg negative subjects liver transplanted after infection of HBV, proved the efficacy of IMMUNOHBs in maintaining the levels of anti HBsAg antibodies above 100 IU/l. In this study IMMUNOHBs was administered with doses of 2000-2160 IU (according to the pack size), every 15 days for a period of six months.
The average of the levels of anti HBsAg antibodies, measured before each of the 12 administrations, were above the considered threshold (403 IU/l for concentration 180 IU/ml with a minimum level of 106 IU/l).
Paediatric population: Published data related to efficacy and safety studies have not revealed major differences between adults and children suffering from the same disorder.
Pharmacokinetics: Human hepatitis B immunoglobulin for intramuscular use is bioavailable in the recipient's circulation after a delay of 2-3 days.
Human hepatitis B immunoglobulin has a half-life of about 3-4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in the reticuloendothelial system.
Toxicology: Preclinical Safety Data: Immunoglobulins are normal constituents of the human body. Moreover, as administration of immunoglobulins in animal studies may lead to the formation of antibodies, preclinical safety data are limited. However, the limited animal studies did not show special risks for humans, based on acute and sub-acute toxicity studies.