Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: CSL Behring (NZ) Ltd, PO Box 62590, Greenlane, Auckland 1546, New Zealand customerservice@cslbehring.com.au www.cslbehring.com.au Manufacturer: CSL Behring (Australia) Pty Ltd, 189–209 Camp Road, Broadmeadows, ...
Intragam P contains functionally intact IgG present in the donor population, with a broad spectrum of antibodies against infectious agents. Adequate doses of intact IgG restore abnormally low IgG levels to the normal range in patients. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects. Intragam P is prepared from pooled human plasma collected from not fewer than 1000 donors. It is made by chromatographic fractionation of the pooled human plasma. The protein is not chemically or enzymatically modified and the Fc and Fab functions are retained. It has an IgG subclass distribution closely proportional to normal human plasma. The manufacturing process contains dedicated steps to reduce the possibility of virus transmission including pasteurisation (60°C for 10 hours) and incubation at low pH.
The efficacy of Intragam P was assessed in 35 patients (age 6–76 years; 21 male) with PID, following the administration of monthly intravenous infusions of Intragam P for six months. The dose of Intragam P was individualised in the range of 0.2–0.67 g/kg. The mean number of days of hospitalisation over the six month period was 2.8±9.0 and the mean number of days absent from work or school due to illness was 5.3±6.4. These figures were similar to historical data relating to other IVIg.
The efficacy of Intragam P was assessed in 17 patients (age 21–72 years; 5 male) with ITP (6 acute, 11 chronic), following intravenous infusion of Intragam P once daily for 1–3 consecutive days. The dose of Intragam P was individualised up to a maximum total cumulative dose of 2 g/kg. Following administration of Intragam P, a total of 13 patients (76.5%) achieved platelet count responses which were good (50 × 109/L–150 × 109/L) or excellent (>150 × 109/L). Platelet counts were maintained at ≥50 × 109/L for up to 35 days with a median of 17.24 days (95% CI 10.35, 24.12). These figures were similar to historical data relating to other IVIg.
The use of Intragam P in the paediatric population has not been established in clinical studies.
Clinical studies of Intragam P did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients.
Intragam P is immediately and completely bioavailable in the recipient’s circulation after intravenous administration.
Intragam P is distributed relatively rapidly between plasma and extravascular fluid. Equilibrium between the intravascular and extravascular compartments is reached after approximately 3 to 5 days.
The half-life of Intragam P may vary from patient to patient. IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
The steady-state kinetic parameters for serum IgG were determined in 11 patients (9 male, age 28–76 years) with PID, following the administration of monthly intravenous infusions of Intragam P for six months. The dose of Intragam P was individualised in the range 0.35–0.53 g/kg. The mean serum IgG concentration ranged from a trough of 7.4±1.1 g/L to a peak of 15.8±1.7 g/L, the mean clearance was 4.1±0.8 mL/h and the mean-half-life 39.7±7.8 days. Mean recovery, the increase in serum IgG concentration as a percentage of the expected concentration after an Intragam P infusion, was 44.0±2.0%.
Immunoglobulins are natural components of the human body. Data from animal testing of acute and chronic toxicity and embryofoetal toxicity of immunoglobulins are inconclusive on account of interactions between immunoglobulins from heterogeneous species and the induction of antibodies to heterologous proteins.
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