CLINICAL PHARMACOLOGY
Carimune™ NF Nanofiltered contains a broad spectrum of antibody specificities against bacterial, viral, parasitic, and mycoplasma antigens, that are capable of both opsonization and neutralization of microbes and toxins. The 3 week half-life of Immune Globulin Intravenous (Human), Carimune™ NF, corresponds to that of Immune Globulin (Human) for intramuscular use, although individual variations in half-life have been observed (12,13). Appropriate doses of Carimune™ NF restore abnormally low immunoglobulin G levels to the normal range. One hundred percent of the infused dose of IGIV-products is available in the recipient's circulation immediately after infusion. After approximately 6 days, equilibrium is reached between the intra- and extravascular compartments, with immunoglobulin G being distributed approximately 50% intravascular and 50% extravascular. In comparison, after the intramuscular injection of immune globulin, the IgG requires 2-5 days to reach its maximum concentration in the
intravascular compartment. This concentration corresponds to about 40% of the injected dose (13).
While Carimune™ NF has been shown to be effective in some cases of Immune Thrombocytopenic Purpura (ITP) (see INDICATIONS AND USAGE), the mechanism of action in ITP has not been fully elucidated. Toxicity from overdose has not been observed on regimens of 0.4 g/kg body weight each day for 5 days (14,15,16). Sucrose is added to Carimune™ NF for reasons of stability and solubility. Since sucrose is excreted unchanged in the urine when given intravenously, Carimune™ NF, may be given to diabetics without compensatory changes in insulin dosage regimen. Please see WARNINGS section.
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