Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease

Wíkström, Björn; Bhandari, Sunil; Bárány, Peter; Kalra, Philip A.; Ladefoged, Søren; Wilske, Jan; Thomsen, Lars L.

doi:10.5301/jn.2011.6248

Cited by 49 publications

(46 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Iron isomaltoside has previously been shown to be safe and well tolerated in patients with IBD,[9,10] chronic kidney disease,[11–13] and chronic heart failure,[14] and in patients undergoing elective or subacute coronary artery bypass graft procedures, valve replacement, or a combination thereof. [15]…”

Section: Introductionmentioning

confidence: 99%

High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23

Dahlerup

Jacobsen

Woude

et al. 2016

Scandinavian Journal of Gastroenterology

Self Cite

View full text Add to dashboard Cite

Objective: Iron isomaltoside (Monofer®) is a high-dose intravenous iron preparation with good tolerability and efficacy in inflammatory bowel disease (IBD) patients with iron deficiency anaemia (IDA). This trial evaluates the safety and efficacy, including effect on intact fibroblast growth factor 23 (iFGF23) of a high single dose and cumulative doses of iron isomaltoside in IBD patients with IDA. Materials and methods: The trial was a prospective, open-label, multi-centre trial conducted in IBD patients with IDA. Based upon haemoglobin (Hb) levels at baseline and weight, the patients received 1500, 2000, 2500 or 3000 mg of iron isomaltoside infused in single doses up to 2000 mg. The outcome measurements included adverse drug reactions (ADRs) and changes in haematology and biochemistry parameters. Results: Twenty-one IBD patients with IDA were enrolled, receiving 1500 (seven patients), 2000 (eight patients), 2500 mg (four patients) or 3000 (two patients) mg of iron. No serious ADRs were observed. Four patients experienced nine mild to moderate ADRs (hypersensitivity, pyrexia, vomiting, constipation, abdominal pain, dyspepsia (two events) and eye allergy (two events)). In total, 15 (75%) patients had an increase in Hb of ≥2.0 g/dL during the trial, with normalisation of ferritin. No changes in iFGF23 or clinically significant hypophosphataemia were found. Conclusion: Rapid infusions of high-dose iron isomaltoside, administered as single doses up to 2000 mg and cumulative doses up to 3000 mg, were without safety concerns and were efficacious in increasing Hb levels in IBD patients. Iron isomaltoside did not induce profound phosphate wasting via increased iFGF23 levels.

show abstract

Section: Introductionmentioning

confidence: 99%

High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23

Dahlerup

Jacobsen

Woude

et al. 2016

Scandinavian Journal of Gastroenterology

Self Cite

View full text Add to dashboard Cite

show abstract

“…As ferric carboxymaltose, it has been tested in patients with iron-deficiency anemia secondary to several diseases. In the setting of CKD, a phase III non-comparative trial of 182 patients (161 in dialysis and 21 in pre-dialysis) has recently been published [29]. Following treatment, Hb levels significantly increased in patients not receiving parenteral iron previously (from 9.92 ± 0.9 g/dl at baseline to 11.12 ± 1.47 g/dl at week 8) and increased slightly or stabilized in patients in maintenance therapy.…”

Section: Iron Isomaltoside 1000mentioning

confidence: 97%

New Erythropoiesis-Stimulating Agents and New Iron Formulations

Locatelli¹,

Vecchio²

2011

Hemodialysis

View full text Add to dashboard Cite

Today, erythropoiesis-stimulating agents (ESAs), together with iron supplementation, are the main tool for anemia correction in chronic kidney disease patients. Over the past decades, a number of attempts have been made to modify the erythropoietin molecule in order to improve its pharmacokinetic and pharmacodynamic properties. More recently, small peptides, which are unrelated to erythropoietin but bind to the same receptor, have been developed. In addition to this, other strategies to stimulate erythropoiesis have been followed, such as activin inhibition or stabilization of hypoxia-inducible transcription factors. Interestingly, the latter have the advantage of being administered orally. New iron molecules, such as ferumoxytol, ferric carboxymaltose and iron isomaltoside 1000, have recently been marketed. These new agents can administered at high doses while releasing minimal free iron. Their safety profile is good, but long- term post- marketing data are still needed to evaluate the occurrence of rare adverse events.

show abstract

“…These novel mechanisms ensure only minimal quantities of ionic iron are released from their carbohydrate shell/matrix, and seem to ensure that free iron adverse effects and subsequent tissue toxicity from reactive oxygen species are negligible. Both of these preparations have removed the need for a test dose for iron administration and can be given relatively rapidly at high doses [29,30]. Therefore, development of local services incorporating the newer preparations may revolve around the cost of the parent drug.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Tolerability of Accelerated-Dose Low-Molecular-Weight Iron Dextran (Cosmofer) in Patients with Chronic Kidney Disease

Cooke

Lamplugh²,

Naudeer³

et al. 2011

Am J Nephrol

View full text Add to dashboard Cite

Introduction: The Renal NSF advocates correction of anaemia in chronic kidney disease patients. Oral iron is often insufficient, while intravenous supplementation replenishes and maintains iron stores. There is a need to administer high doses of iron in a single rapid infusion to enable efficient costs, effective utilisation of time for patients and staff and optimal use of resources. Methods: We performed a prospective study of consecutive patients referred for iron dextran (Cosmofer) therapy. This was administered over 2 h 40 min compared with the normal regime of 4–6 h. Blood pressure was recorded throughout administration. Adverse drug reactions were recorded over 2 weeks. Serum ferritin, haemoglobin and estimated glomerular filtration rate were measured at baseline and 3 months. Results: One hundred patients (59 male, mean age 69 years), received a median dose of 1,000 mg Cosmofer in a median time of 2 h 40 min. Mean serum ferritin rose from 178 at baseline to 413 µg/l (p < 0.001). Mean haemoglobin rose by 1.5 g/dl (p < 0.001). There was no decline in estimated glomerular filtration rate after 3 months. No adverse reactions were noted. Conclusion: We demonstrated that accelerated administration of iron dextran is safe and effective with no short-term effects on renal function. This resulted in a time saving of approximately 67 hours.

show abstract

Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease

Abstract: Iron isomaltoside 1000 was clinically well tolerated, safe and effective. This new intravenous iron may offer a further valuable choice in treating the anemia of CKD.

Cited by 49 publications

References 15 publications

High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23

High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23

New Erythropoiesis-Stimulating Agents and New Iron Formulations

Efficacy and Tolerability of Accelerated-Dose Low-Molecular-Weight Iron Dextran (Cosmofer) in Patients with Chronic Kidney Disease

Contact Info

Product

Resources

About