m prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS and recurrent bacterial infections
The recommended dose is 0.2-0.4 g/kg every three to four weeks.
Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation
The recommended dose is 0.2-0.4 g/kg every three to four weeks. The trough levels should be maintained above 5g/l.
Primary immune thrombocytopenia
There are two alternative treatment schedules:
• 0.8-1g/kg given on day one; this dose may be repeated once within 3 days
• 0.4 g/kg given daily for two to five days.
The treatment can be repeated if relapse occurs.
Guillain Barré syndrome
0.4 g/kg/day over 5 days.
Kawasaki Disease
1.6-2 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Multifocal Motor Neuropathy (MMN)
Starting dose: 2 g/kg given over 2-5 days.
Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
The dose recommendations are summarised in the following table:
Indication
Dose
Frequency of injections
Replacement therapy in primary immunodeficiency
starting dose:
0.4-0.8 g/kg
thereafter:
0.2-0.8 g/kg
every 3-4 weeks to obtain IgG trough level of at least 5-6 g/l
Replacement therapy in secondary immunodeficiency
0.2-0.4 g/kg
every 3-4 weeks to obtain IgG trough level of at least 5-6 g/l
Congenital AIDS
0.2-0.4 g/kg
every 3-4 weeks
Hypogammaglobulinaemia (<4 g/l) in patients after allogeneic haematopoietic stem cell transplantation
0.2-0.4 g/kg
every 3-4 weeks to obtain IgG trough level above 5g/l
Immunomodulation:
Primary immune thrombocytopenia
0.8-1 g/kg
or
0.4 g/kg/d
on day 1, possibly repeated once within 3 days
for 2-5 days
Guillain Barré syndrome
0.4g/kg/d
for 5 days
Kawasaki disease
1.6-2 g/kg
or
2 g/kg
in divided doses for 2-5 days in association with acetylsalicylic acid
in one dose in association with acetylsalicylic acid
Multifocal Motor Neuropathy (MMN)
starting dose: 2 g/kg
maintenance dose: 1 g/kg
or
2 g/kg
given over 2-5 days
every 2-4 weeks
or
every 4-8 weeks
Paediatric population
The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Method of administration
For intravenous use.
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/kg BW/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/kg BW/hr. For further precautions for use see section 4.4.
If dilution prior to infusion is required, KIOVIG may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5% immunoglobulin). For instructions on dilution of the medicinal product before administration, see section 6.6.
Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.
4.3 Contraindications
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