Active Ingredient: Human normal immunoglobulin G
Immunomodulatory therapy in adults, children and adolescents (0-18 years):
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous, between 0.2 grams human normal immunoglobulin G per kilogram of body weight and 0.4 grams human normal immunoglobulin G per kilogram of body weight, divided every 1 to 2 days, 1 to 2 doses in total, over the duration of 1 week.
The therapy with IgG solution for subcutaneous injection is initiated 1 week after the last IVIg infusion. The recommended subcutaneous dose is 0.2 to 0.4 g/kg body weight per week administered in 1 or 2 sessions over 1 or 2 consecutive days. The initial subcutaneous dose may be a 1:1 conversion from the previous IVIG dose (calculated as weekly dose).
Example a 1g/kg IVIG dose given every 3 weeks would convert into a 0.33g/kg weekly dose. The weekly dose can be divided into smaller doses and administered by desired number of times per week. For dosing every two weeks, double the weekly IgG dose.
The dose may need to be adapted to achieve the desired clinical response. Patient’s individual clinical response should be the primary consideration in dose adjustment. In case of clinical deterioration the dose may be increased to the recommended maximum of 0.4g/kg weekly dose.
IgG maintenance therapy in CIDP has not been studied for periods longer than 18 months. Individualize the duration of any treatment beyond 18 months based upon the patient’s response and demonstrated need for continued therapy.
Efficacy of IgG solution for subcutaneous injection has been demonstrated over placebo after switching from intravenous immunoglobulins (IVIG). Direct comparative data for IgG versus IVIG are not available.
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 in replacement therapy indications.
IgG solution for subcutaneous injection has not been evaluated in clinical studies in paediatric patients with CIDP who are under the age of 18.
Human normal immunoglobulin G solution for subcutaneous injection may be infused into sites such as abdomen, thigh, upper arm, and/or lateral hip. More than one infusion device can be used simultaneously. The amount of product infused into a particular site may vary. In infants and children, infusion site may be changed every 5-15 ml. In adults doses may be given up to 50 ml/site. There is no limit to the number of infusion sites. Infusion sites should be at least 5 cm apart.
The solution can be infused using:
The recommended initial infusion rate depends on the individual patient’s needs.
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