Kiovig

/ Takeda

The dose and dose regimen are dependent on the indication.
In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. 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 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. Trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dose and aim for higher trough levels.
Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple to pneumococcal immunisation; children and adolescents with 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 5 g/l.
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.
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.
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, 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. 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). Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.
See prescribing information for full details.

IVIg can be used in all age ranges, unless otherwise specified.
Replacement therapy in: Primary immunodeficiency syndromes with impaired antibody production. Hypogammaglobulinemia and recurrent bacterial infections in patients with chronic lymphocytic leukemia, in whom prophylactic antibiotics have failed. Hypogammaglobulinemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation. Children and adolescents (age 0-18) with congenital AIDS and recurrent bacterial infections. Hypogammaglobulinemia in patients after allogeneic hematopoietic stem cell transplantation (HSCT).
Immunomodulation: Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. Guillain Barre syndrome. Kawasaki disease.

Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.

See prescribing information for full details.

See prescribing information for full details.

See prescribing information for full details.