A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer®), a new intravenous iron preparation and its clinical implications

Jahn, Markus; Andreasen, Hans B.; Fütterer, Sören; Nawroth, Thomas; Schünemann, Volker; Kolb, Ute; Hofmeister, Wolfgang; Múñoz, Manuel; Bock, Klaus; Meldal, Morten; Langguth, Peter

doi:10.1016/j.ejpb.2011.03.016

Cited by 216 publications

(254 citation statements)

References 36 publications

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“…This is supported by the study of Jahn et al, which noted labile free iron levels after administration of ferumoxytol approximately 60% of that seen with iron dextran (See Supporting Information on line Fig. 1 [59]. While considerably lower, this amount of labile free iron is not insignificant.…”

Section: Administration Of Parenteral Iron In Practicesupporting

confidence: 67%

How we diagnose and treat iron deficiency anemia

2015

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It is estimated that one‐third of the world's population is anemic, the majority being due to iron deficiency (ID). In adults, ID is associated with fatigue in the absence of anemia, restless legs syndrome, pica and, in neonates, delayed growth and development. In adolescents, ID is associated with decrements in learning and behavioral abnormalities. In the absence of a clear cause, search for a source of bleeding is indicated. No single test is diagnostic of ID unless the serum ferritin is low or the percent transferrin saturation is low with an elevated total iron binding capacity. Oral iron is considered front line therapy except for conditions such as gastric bypass, heavy uterine bleeding, inflammatory bowel disease, and hereditary hemorrhagic telangiectasia. Oral iron has many unpleasant side effects, resulting in low patient adherence. For patients intolerant of, or unresponsive to, oral iron, intravenous (IV) administration is the preferred route. While early formulations were associated with a high incidence of serious adverse events (SAEs), newer formulations are much safer with SAEs occurring very infrequently. Full replacement doses can be administered in a matter of minutes to a few hours. Nevertheless, there remains a reluctance to use IV iron due to a misunderstanding of the safety of the available formulations. IV iron is safe and effective in all clinical circumstances including pregnancy. The preponderance of published evidence suggests IV iron therapy is underutilized and we believe that IV iron should be moved forward in the treatment of ID and iron deficiency anemia (IDA). Am. J. Hematol. 91:31–38, 2016. © 2015 Wiley Periodicals, Inc.

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Section: Administration Of Parenteral Iron In Practicesupporting

confidence: 67%

How we diagnose and treat iron deficiency anemia

2015

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“…Analytic techniques demonstrate that all IV formulations are associated with some free or labile iron release [5]. While the mechanism for the varying degrees of free, nontransferrin bound iron release remains a question, those preparations with less tightly bound iron must be given in smaller repetitive doses to avoid significant infusion reactions [2].…”

Section: Discussionmentioning

confidence: 99%

“…Over the last several decades, a number of iron oxides with varying carbohydrate shells have been introduced that permit delivery of iron intravenously with very low rates of serious adverse events (SAEs). Two iron preparations, ferric gluconate, and iron sucrose can be administered at low doses over relatively short periods of time, but doses more than 250 mg (ferric gluconate) and 300 mg (iron sucrose) are not recommended [2] due to high rates of infusion reactions, presumably due to free iron release from less tightly bound carbohydrate carriers [3][4][5]. Subsequently, multiple clinic visits are required to provide patients with a 1 g treatment course of IV iron.…”

Section: Introductionmentioning

confidence: 99%

“…Nonetheless, safety concerns abound. Further, more rapid administration of iron dextran may be associated with acute infusion reactions that may be due to the toxicity of labile or free iron release [4,5]. Over the past 3 years, it has been our standard to treat IDA with IV iron, utilizing LMW iron dextran administered as a TDI of 1 g delivered over 1 hr.…”

Section: Introductionmentioning

confidence: 99%

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Safety and efficacy of total dose infusion of 1,020 mg of ferumoxytol administered over 15 min

et al. 2013

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For the majority of patients with iron deficiency anemia (IDA), a full course of intravenous (IV) iron is 1 g. Most IV irons require 5–10 administrations of 100–300 mg. We have successfully employed 1 g low molecular weight iron dextran over 1 hr. For further convenience for patients and physicians, we explored the administration of 1.02 g of ferumoxytol over 15 min instead of the approved 2 × 510 mg injections. Sixty patients with IDA, (hemoglobin <11 g/dL, transferrin saturation [TSAT] ≤20%, and ferritin <100 ng/mL) with an inadequate response or intolerance to oral iron, received 1020 mg ferumoxytol over 15 min. Vital signs were measured for 1 hr. Adverse events (AEs) were collected via telephone at 1, 2, and 7 days. Follow‐up visits occurred at 4 and 8 weeks for efficacy assessments. The primary endpoint was safety and tolerability. Secondary efficacy endpoints included mean change in hemoglobin, TSAT, and red cell distribution width. No serious adverse events (SAEs) occurred. Fifty‐eight patients received the planned dose. Twenty‐six out of sixty (43.3%) patients reported AEs of which 13 were mild and transient during infusion. All resolved within minutes. Fourteen patients reported self‐limited arthralgias, myalgias, and/or headache within 24–48 hr. At Baseline, the mean hemoglobin was 9.4 g/dL. The mean increments at Week 4 and 8 were 2.1 and 2.6 g/dL, respectively. Ferumoxytol, administered as 1.02 g infusion over 15 min was well tolerated with no SAEs and demonstrated excellent efficacy. If corroborated in future studies this represents an improved method of treating IDA. Am. J. Heamtol. 88:944–947, 2013. © 2013 The Authors. American Journal of Hematology published by Wiley Periodicals, Inc.

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“…Commercially available IV iron formulations consist of an iron oxyhydroxide core surrounded by carbohydrate shells of various sizes and polysaccharide branch characteristics in colloidal suspensions [4]. The size of commercially available IV iron-carbohydrate complexes range from 5 to 100 nm and thus meet the definition for nanoparticles, enhancing the complexity of PK studies of these agents [4].…”

mentioning

confidence: 99%

Evaluating Plasma Pharmacokinetics of Intravenous Iron Formulations: Judging Books by Their Covers?

Pai

2014

Clin Pharmacokinet

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A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer®), a new intravenous iron preparation and its clinical implications

Cited by 216 publications

References 36 publications

How we diagnose and treat iron deficiency anemia

How we diagnose and treat iron deficiency anemia

Safety and efficacy of total dose infusion of 1,020 mg of ferumoxytol administered over 15 min

Evaluating Plasma Pharmacokinetics of Intravenous Iron Formulations: Judging Books by Their Covers?

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