Iron (III) isomaltoside 1000

Abstract

Intravenous (iv.) iron is now the recommended treatment for iron deficiency anemia if oral preparations have failed or in those undergoing hemodialysis. Iron isomaltoside is a new iv. iron preparation, licensed since 2009 in the UK and Europe. The iron is tightly bound within a nonionic isomaltoside carbohydrate matrix, as opposed to most other iv. iron preparations that use branched polymers to form a carbohydrate shell. This conformation produces a low immunogenic potential, which allows high single-dose infusions to adequately replenish stores. Two Phase III, open-label, noncomparative, multicenter clinical trials have investigated the safety profile of iron isomaltoside in chronic kidney disease and chronic heart failure. Two serious adverse events were observed (Staphylococcus aureus sepsis and angina pectoris), although their relationship to the drug was questioned. Significant hemoglobin and serum ferritin rises were seen in the chronic kidney disease group. The chronic heart failure group showed a significant serum ferritin rise and improved ‘overall quality of life’ but a nonsignificant hemoglobin rise. Preparations of iv. iron can cause renal injury, possibly through oxidative stress. Modern preparations, such as iron isomaltoside and ferumoxytol, have demonstrated less free iron release and hence may theoretically cause less renal damage. The cost of iron isomaltoside is greater than some of the current standard preparations used in most hospitals in the UK and Europe. However, when overheads and patient throughput are calculated, it may be a more cost-effective therapy than current therapies in the UK, owing to its faster infusion rate. Currently, there remains limited data on efficacy, safety and cost–effectiveness. Although initial data are encouraging, they come from only three published small trials, thus restricting the conclusions that can be made. Future research needs to concentrate on comparative analyses with other iv. iron therapies.

Keywords::

• anaemia
• anemia
• chronic kidney disease
• dialysis
• iron deficiency
• iron deficiency anemia
• iron isomaltoside
• monofer
• oxidative stress
• renal

Financial & competing interests disclosure

TAR Mace has acted as a subinvestigator in a multicenter trial sponsored by Pharmacosmos. S Bhandari has acted as an investigator in multicenter trials sponsored by Pharmacosmos, Amgen and Vifor, and has received travel grants from Pharmacosmos in addition to honoraria from Pharmacosmos, Amgen, Shire, MSD and Takeda Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.