Octagam 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 dosage regimen is dependent on the indication.
In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.
The following dosage 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 - 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 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 dosage 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 dosage 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 myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS with 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 - 2.0 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.
The dosage recommendations are summarised in the following table: (see Table 1.)

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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.
Method of administration: For intravenous use.
Human normal immunoglobulin should be infused intravenously at an initial rate of 1 ml/kg/hour for 30 minutes. If well tolerated (see Precautions), the rate of administration may gradually be increased to a maximum of 5 ml/kg/hour.