Kiovig Dosage/Direction for Use

Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Posology: 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.
Replacement therapy in primary immunodeficiency syndromes: 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.
Secondary immunodeficiencies (as defined in Indications/Uses.): 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.
Primary immune thrombocytopenia: There are two alternative treatment schedules: 0.8-1 g/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 (possible repeat of dosing in case of relapse).
Kawasaki Disease: 2 g/kg should be administered as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Chronic inflammatory demyelinating polyneuropathy (CIDP): 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.
Multifocal Motor Neuropathy (MMN): 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: See Table 2.

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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 previously mentioned conditions.
Hepatic impairment: No evidence is available to require a dose adjustment.
Renal impairment: No dose adjustment unless clinically warranted, see Precautions.
Elderly: No dose adjustment unless clinically warranted, see Precautions.
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 Precautions), 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 Precautions.
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 Special precautions for disposal and other handling under Cautions for Usage.
Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.