Active Ingredient: Human normal immunoglobulin G
Replacement therapy in adults, children and adolescents (0-18 years) in:
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, in total between 0.2 grams human normal immunoglobulin G per kilogram of body weight and 0.5 grams human normal immunoglobulin G per kilogram of body weight,. Afterwards, subcutaneous, in total between 0.4 grams human normal immunoglobulin G per kilogram of body weight and 0.8 grams human normal immunoglobulin G per kilogram of body weight,.
The medicinal product should be administered via the subcutaneous route.
In replacement therapy the dose may need to be individualised for each patient dependent on the clinical response and serum IgG trough levels. The following dose regimens are given as a guideline.
The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/l and aim to be within the reference interval of serum IgG for age. A loading dose of at least 0.2 to 0.5 g/kg (1.0 to 2.5 ml/kg) body weight may be required. This may need to be divided over several days. After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals to reach a cumulative monthly dose of the order of 0.4 to 0.8 g/kg (2.0 to 4.0 ml/kg) body weight. Each single dose may need to be injected at different anatomic sites.
Trough levels should be measured and assessed in conjunction with the patient’s clinical response. Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.
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.
Human normal immunoglobulin G solution for subcutaneous injection was evaluated in 68 paediatric subjects with PID aged 2 to <12 years and in 57 adolescents aged 12 to <18 years. No paediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
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.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
