Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221, Vienna, Austria
Replacement therapy in adults, and children and adolescents (0-18 years) in:
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Immunomodulation in adults, and children and adolescents (0-18 years) in:
Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
The dose and dose regimen is dependent on the indication.
In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. Dose based on bodyweight may require adjustment in underweight or overweight patients.
The following dose regimens are given as a guideline.
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.
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.
There are two alternative treatment schedules:
The treatment can be repeated if relapse occurs.
0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
2 g/kg should be administered as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Starting dose: 2 g/kg divided over 2-5 consecutive days.
Maintenance doses: 1 g/kg over 1-2 consecutive days every 3 weeks.
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued. If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response. The dosing and intervals may have to be adapted according to the individual course of the disease.
Starting dose: 2 g/kg given over 2-5 consecutive days.
Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks over 2-5 days.
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued. If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response. The dosing and intervals may have to be adapted according to the individual course of the disease.
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 maintenance dose: 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 |
| 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 | 0.4 g/kg/d | for 5 days |
| Kawasaki disease | 2 g/kg | in one dose in association with acetylsalicylic acid |
| Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | starting dose 2g/kg maintenance dose: 1g/kg | In divided doses over 2-5 days every 3 weeks over 1-2 days |
| 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 over 2-5 days |
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.
No evidence is available to require a dose adjustment.
No dose adjustment unless clinically warranted, see section 4.4.
No dose adjustment unless clinically warranted, see section 4.4.
For intravenous use.
Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kgBW/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. 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.
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4).
Smaller children below the age of 5 years may be particularly susceptible to volume overload. Therefore, dosing should be carefully calculated for this population. In addition, children with Kawasaki Disease are at especially high risk due to underlying cardiac compromise so dose and rate of administration should be carefully controlled.
2 years.
If dilution to lower concentrations is required, immediate use after dilution is recommended. The in-use stability of KIOVIG after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) immunoglobulin has been demonstrated for 21 days at 2°C to 8°C as well as 28°C to 30°C; however, these studies did not include the microbial contamination and safety aspect.
Do not store above 25°C.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
10, 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl).
Pack size: 1 vial.
Not all presentations may be marketed.
The product should be brought to room or body temperature before use.
If dilution is required, 5% glucose solution is recommended. For obtaining an immunoglobulin solution of 50 mg/ml (5%), KIOVIG 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution. It is recommended that during dilution the risk of microbial contamination is minimised.
The product should be inspected visually for particulate matter and discolouration prior to administration. The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.
KIOVIG should only be administered intravenously. Other routes of administration have not been evaluated.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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