Secondary immunodeficiencies

Active Ingredient: Immunoglobulins, normal human, IV

Indication for Immunoglobulins, normal human, IV

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.

* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines

For this indication, competent medicine agencies globally authorize below treatments:

0.2-0.4 g/kg every 3-4 weeks

For:

Dosage regimens

Intravenous, between 0.2 grams immunoglobulins, normal human, IV per kilogram of body weight and 0.4 grams immunoglobulins, normal human, IV per kilogram of body weight, once every 3 to 4 weeks.

Detailed description

The recommended dose is 0.2-0.4 g/kg every three to four weeks.

IgG trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.

Dosage considerations

Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kg BW/hr for 30 minutes. If well tolerated (see section 4.4), the rate of administration may gradually be increased to a maximum of 6 ml/kgBW/hr.

Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kgBW/hr.

Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.

Active ingredient

Immunoglobulins, normal human, IV

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

Read more about Immunoglobulins, normal human, IV

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