Active Ingredient: Immunoglobulins, normal human, IV
Replacement therapy in primary immunodeficiency syndromes.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 0.4 grams immunoglobulins, normal human, IV per kilogram of body weight and 0.8 grams immunoglobulins, normal human, IV per kilogram of body weight, once, over the duration of 3 to 4 weeks. Afterwards, intravenous, between 0.2 grams immunoglobulins, normal human, IV per kilogram of body weight and 0.8 grams immunoglobulins, normal human, IV per kilogram of body weight, once every 3 to 4 weeks, over the duration of 3 to 6 months.
The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/L. Three to six months are required after the initiation of therapy for equilibration (steady-state IgG levels) to occur. The recommended starting dose is 0.4-0.8 g/kg given once, followed by at least 0.2 g/kg given every three to four weeks.
The dose required to achieve a trough level of 5-6 g/L is of the order of 0.2-0.8 g/kg/month. The dose interval when steady state has been reached varies from 3-4 weeks.
IgG trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of bacterial infection, it may be necessary to increase the dose and aim for higher trough levels.
Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kg BW/hr for 30 minutes. If well tolerated, 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.
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