6
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Iron isomaltoside 1000: a new high dose option for parenteral iron therapy

      editorial

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Iron isomaltoside 1000 (Monofer®) is a new dextran-free parenteral iron product, currently approved in 22 EU countries. Iron isomaltoside 1000 consists of iron and a carbohydrate moiety where the iron is tightly bound in a matrix structure, which enables a controlled and slow release of iron to iron-binding proteins, avoiding toxicity. The carbohydrate,isomaltoside 1000, is a purely linear chemical structure with low immunological activity. Due to the structure of iron isomaltoside 1000 and the low anaphylactic potential, there is no requirement for a test dose, and it can be administered in high doses with a maximum dosage of 20 mg/kg within 30-60 minutes in one visit. Thus, iron isomaltoside 1000 offers the broadest dosage range compared to other parenteral iron products on the market. Due to the dose flexibility, the possibility of providing full iron correction in one single visit makes iron isomaltoside 1000 highly convenient for both the health care professional and the patient. Clinical studies of iron isomaltoside 1000 show that it is an effective and well-tolerated treatment of iron deficiency anaemia with a favourable safety profile. Furthermore, iron isomaltoside 1000 does not seem to induce hypophosphataemia.

          Related collections

          Most cited references40

          • Record: found
          • Abstract: found
          • Article: not found

          Iron modifies plasma FGF23 differently in autosomal dominant hypophosphatemic rickets and healthy humans.

          In autosomal dominant hypophosphatemic rickets (ADHR), fibroblast growth factor 23 (FGF23) resists cleavage, causing increased plasma FGF23 levels. The clinical phenotype includes variable onset during childhood or adulthood and waxing/waning of hypophosphatemia. Delayed onset after puberty in females suggests iron status may be important. Studies were performed to test the hypothesis that plasma C-terminal and intact FGF23 concentrations are related to serum iron concentrations in ADHR. Cross-sectional and longitudinal studies of ADHR and a cross-sectional study in healthy subjects were conducted at an academic medical center. Participants included 37 subjects with ADHR mutations from four kindreds and 158 healthy adult controls. The relationships of serum iron concentrations with plasma C-terminal and intact FGF23 concentrations were evaluated. Serum phosphate and 1,25-dihydroxyvitamin D correlated negatively with C-terminal FGF23 and intact FGF23 in ADHR but not in controls. Serum iron was negatively correlated to both C-terminal FGF23 (r = -0.386; P < 0.05) and intact FGF23 (r = -0.602; P < 0.0001) in ADHR. However, control subjects also demonstrated a negative relationship of serum iron with C-terminal FGF23 (r = -0.276; P < 0.001) but no relationship with intact FGF23. Longitudinally in ADHR subjects, C-terminal FGF23 and intact FGF23 concentrations changed negatively with iron concentrations (P < 0.001 and P = 0.055, respectively), serum phosphate changed negatively with C-terminal FGF23 and intact FGF23 (P < 0.001), and there was a positive relationship between serum iron and phosphate (P < 0.001). Low serum iron is associated with elevated FGF23 in ADHR. However, in controls, low serum iron was also associated with elevated C-terminal FGF23, but not intact FGF23, suggesting cleavage maintains homeostasis despite increased FGF23 expression.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial.

            The objective was to evaluate efficacy and safety of rapid, large-dose intravenous (IV) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding. In a randomized, controlled trial, 477 women with anemia, iron deficiency, and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose ( or= 12 g/dL) of anemia (73% vs. 50%, p < 0.001). Patients treated with ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue (p < 0.05). There were no serious adverse drug events. In patients with iron deficiency anemia due to heavy uterine bleeding, rapid IV administration of large doses of a new iron agent, ferric carboxymaltose, is more effective than oral iron therapy in correcting anemia, replenishing iron stores, and improving quality of life.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Update on adverse drug events associated with parenteral iron.

              We previously compared the safety profile of three formulations of intravenous iron used during 1998-2000 and found higher rates of adverse drug events (ADEs) associated with the use of higher molecular weight iron dextran and sodium ferric gluconate complex compared with lower molecular weight iron dextran. Since that time, iron sucrose has become widely available and clinicians have gained additional experience with sodium ferric gluconate complex. We obtained data from the United States Food and Drug Administration (FDA) on ADEs attributed to the provision of four formulations of intravenous iron during 2001-2003, including higher and lower molecular weight iron dextran, sodium ferric gluconate complex and iron sucrose. We estimated the odds of intravenous iron-related ADEs using 2 x 2 tables and the chi(2) test. The total number of reported parenteral iron-related ADEs was 1141 among approximately 30,063,800 doses administered, yielding a rate of 3.8 x 10(-5), or roughly 38 per million. Eleven individuals died in association with the ADE. Relative to lower molecular weight iron dextran, total and life-threatening ADEs were significantly more frequent among recipients of higher molecular weight iron dextran and significantly less frequent among recipients of sodium ferric gluconate complex and iron sucrose. The absolute rates of life-threatening ADEs were 0.6, 0.9, 3.3 and 11.3 per million for iron sucrose, sodium ferric gluconate complex, lower molecular weight iron dextran and higher molecular weight iron dextran, respectively. Based on differences in the average wholesale price of iron sucrose and lower molecular weight iron dextran in the US, the cost to prevent one life-threatening ADE related to the use of lower molecular weight iron dextran was estimated to be 5.0-7.8 million dollars. The cost to prevent one lower molecular weight iron dextran-related death was estimated to be 33 million dollars. The frequency of intravenous iron-related ADEs reported to the FDA has decreased, and overall, the rates are extremely low. This is the fourth report suggesting increased risks associated with the provision of higher molecular weight iron dextran. Life-threatening and other ADEs appear to be lower with the use of non-dextran iron formulations, although the cost per ADE prevented is extremely high.
                Bookmark

                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Journal
                nep
                Portuguese Journal of Nephrology & Hypertension
                Port J Nephrol Hypert
                Sociedade Portuguesa de Nefrologia (Lisboa )
                0872-0169
                January 2012
                : 26
                : 1
                : 13-24
                Affiliations
                [1 ] Saldorf Royal Hospital United Kingdom
                [2 ] University of Copenhagen Denmark
                [3 ] University of Copenhagen Denmark
                Article
                S0872-01692012000100002
                b549c249-8203-4402-b6b2-12aa77d2f39a

                http://creativecommons.org/licenses/by/4.0/

                History
                Product

                SciELO Portugal

                Self URI (journal page): http://www.scielo.mec.pt/scielo.php?script=sci_serial&pid=0872-0169&lng=en
                Categories
                UROLOGY & NEPHROLOGY

                Urology
                High dose,iron deficiency anaemia,iron isomaltoside,iron treatment
                Urology
                High dose, iron deficiency anaemia, iron isomaltoside, iron treatment

                Comments

                Comment on this article