KIOVIG 100mg/ml solution for infusion
1. Name of the medicinal product
KIOVIG 100 mg/ml solution for infusion
2. Qualitative and quantitative composition
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin ……………100 mg
(purity of at least 98% IgG)
Each vial of 10 ml contains: 1 g of human normal immunoglobulin
Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin
Each vial of 50 ml contains: 5 g of human normal immunoglobulin
Each vial of 100 ml contains: 10 g of human normal immunoglobulin
Each vial of 200 ml contains: 20 g of human normal immunoglobulin
Each vial of 300 ml contains: 30 g of human normal immunoglobulin
Distribution of IgG subclasses (approx. values):
IgG1 ≥56.9%
IgG2 ≥26.6%
IgG3 ≥3.4%
IgG4 ≥1.7%
The maximum IgA content is 140 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion
The solution is clear or slightly opalescent and colourless or pale yellow.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, and children and adolescents (0-18 years) in:
• Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
• 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 myeloma patients who have failed to respond to pneumococcal immunisation.
• Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).
• Congenital AIDS and recurrent bacterial infections.
Immunomodulation in adults, and children and adolescents (0-18 years) in:
• Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
• Guillain Barré syndrome.
• Kawasaki disease.
• Multifocal Motor Neuropathy (MMN).
4.2 Posology and method of administration
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. 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 who |
