Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration
ATC code: J06B A02

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.


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Human normal immunoglobulin contains the IgG antibodies present in the normal population.
It is prepared from pooled material from not fewer than 1000 donations. It has a distribution of immunoglobulin G-subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G level to the normal range.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

Paediatric population
A prospective open-label phase III study was performed with OCTAGAM in 17 children/adolescent patients (median age 14.0 years, range 10.5 to 16.8) suffering from primary immunodeficiency disorders. Previously treated patients received 0.2 g/kg every 3 weeks for the 6 months study period. Naive patients received 0.4 g/kg every 3 weeks for the first 3 months, followed by 0.2 g/kg for the rest of the study period. Dosages had to be adjusted to maintain an IgG trough level of at least 4 g/L.
•   No. of days out of school: 11.2 days/patient/year
•   No. of days with fever: 4.1 days/patient/year
•   No. of days on antibiotics: 19.3 days/patient/year
•   No. of days with infections: 29.1 days/patient/year.
The severity of infections was assessed as mild. No severe infections leading to hospitalisation were observed.

Pharmacokinetic Properties

5.2 Pharmacokinetic properties
Human normal 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.
Human normal immunoglobulin has a half-life of about 40 days. This half-life may vary from patient to patient, in particular in primary immunodeficiency.
IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

Paediatric population
A prospective open-label phase III study was performed with OCTAGAM in 17 children/adolescent patients (median age 14.0 years, range 10.5 to 16.8) suffering from primary immunodeficiency disorders. Patients were treated for a period of 6 months.
During the treatment period, the average Cmax in steady state was 11.1 ± 1.9 g/L; the average trough level was 6.2 ± 1.8 g/L. The mean terminal half-life of total IgG was 35.9 ± 10.8 days with a median of 34 days. The mean volume of distribution for the total IgG was 3.7 ± 1.4 L and the total body clearance was 0.07 ± 0.02 L/day.



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