Nefro - 25-3 - MIOLO.indd
نویسندگان
چکیده
The antigenicity of a number of different intravenous iron preparations was tested by reverse single radial immunodiffusion with antidextran antibodies. The tested products are low molecular weight iron dextran, ferumoxytol, iron isomaltoside 1000, sodium ferric gluconate, iron sucrose, and ferric carboxymaltose. Dextran-induced anaphylactic reactions have been clinically observed with low molecular weight iron dextran and with ferumoxytol, which contains a dextran derivative as ligand, whereas no dextraninduced anaphylactic reactions have been reported since its introduction in 2010 with iron isomaltoside 1000, which contains a ligand based on dextran 1. The results of the immunoassay confirmed that the dextran-free preparations sodium ferric gluconate, iron sucrose, and ferric carboxymaltose do not crossreact with antidextran antibodies. In contrast, low molecular weight iron dextran and ferumoxytol reacted with the antibodies, as demonstrated by the formation of a precipitation ring. As expected, dextran 1 did not cross-react with antidextran antibodies. Iron isomaltoside 1000 formed a precipitation ring, which suggests that if dextran 1 surrounds the polynuclear iron core, it can act as a polyvalent, higher molecular weight dextran and thus cross-react with the antibodies. Because of the limited number of patients and the exclusion criteria selected for clinical registration studies, e.g. previous hypersensitivity to iron dextran or other iron complexes, rare adverse events such as dextran-induced anaphylactic reactions often do not occur in controlled studies, as was the case with ferumoxytol. However, the presented immunodiffusion assay yielded results in agreement with post-marketing experience for five preparations, including ferumoxytol. Thus, this method could be a valuable tool for the determination of antidextran reactivity of new intravenous iron preparations.
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