Iron sucrose – characteristics, efficacy and regulatory aspects of an established treatment of iron deficiency and iron-deficiency anemia in a broad range of therapeutic areas

Parenteral Iron Sucrose Therapy for Moderate and Severe Iron-Deficiency Anemia in Pregnancy

“…Recently new intravenous iron products with better safety profiles were launched to the market. Iron sucrose, which is a dextran free product and has a satisfying safety profile without a need for a test dose (unless the patient has a history for drug allergies), has become the leading intravenous iron compound in the market (8,9). When compared with oral iron for pregnant women with severe iron deficiency anemia, intravenous iron sucrose resulted in significantly higher mean hemoglobin and ferritin levels and those patients treated with iron sucrose achieved maximum hemoglobin levels in half the time (10-13).…”

Iron status and choice of iron therapy during pregnancy: advantages and disadvantages

“…62 Sodium ferric gluconate, IS, and FCM do not contain dextran or any dextran derivatives and thus do not crossreact with anti-dextran antibodies in vitro. 63 IS belongs to the iron complexes of the half robust and medium strong type (molecular mass between 30,000 and 100,000 Da), which after IV administration, deliver the complexed iron from the serum to endogenous ironbinding proteins with a half-life of 90 min.…”

Cardiovascular outcomes of intravenous iron in perspective of clinical trials and the use of different iron preparations

“…Therefore, evaluation of products developed with reference to a complex originator drug should include appropriate comparative clinical and/or nonclinical studies that evaluate pharmacokinetics, pharmacodynamics and safety as well as efficacy in relevant patient populations. Unless therapeutic equivalence and similar safety profiles are shown in comparative studies, experts discourage interchange and automatic substitution between non-biological complex drugs and their follow-on (similar) products [16]. Publications should clarify from the outset whether an originator or a similar product was used, especially if the study results may impact clinical decision making and treatment choice.…”