Safety of Intravenous Iron – Cosmofer and Monofer Therapy in Peritoneal Dialysis and Non-Dialysis-Dependent Chronic Kidney Disease Patients

Abstract

Safety of parenteral iron therapy is critical and has been demonstrated in several studies, but concerns persist on safety. We performed a retrospective single-center study investigating the safety and efficacy of parenteral iron administration using 2 iron preparations-Monofer and Cosmofer (Pharmacosmos A/S, Holbaek, Denmark)-in patients with chronic kidney disease (CKD), on peritoneal dialysis (PD) and non-dialysis. A database of CKD patients receiving intravenous (IV) iron was analyzed. Side effects were recorded during infusion, post-infusion, and after 48 hours. In a population of CKD patients (non-dialysis and PD), IV iron is safe with few major adverse effects for these 2 IV iron preparations studied with similar dosing schedules. These data provide reassurance on the relative short-term safety of IV iron preparations regarding acute infusion-related hypersensitivity reactions.

NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease

“…Data from clinical trials have confirmed the good efficacy and safety profile of IIM in patients with CKD [8,[16][17][18][19]. In addition, observational studies in CKD conducted in Germany [20], Scandinavia [21], and the UK [22], have demonstrated that IIM is well tolerated and effective in real-world settings.…”

The role of iron repletion in adult iron deficiency anemia and other diseases

“…In patients with NDD‐CKD, IV iron has been shown to rapidly correct anemia and reduce need for ESAs relative to oral iron without evidence of renal toxicity, cardiovascular, or infectious events . Rates of acute infusion‐related hypersensitivity reactions are low with IV iron use in NDD‐ and PD‐CKD patients and the safety of short‐term IV iron is established by multiple trials . A trial of oral iron may however be considered in NDD‐CKD patients based on the severity of their anemia, previous response to oral iron, venous access, and cost considerations .…”

“…66 Rates of acute infusion-related hypersensitivity reactions are low with IV iron use in NDD-and PD-CKD patients and the safety of short-term IV iron is established by multiple trials. [67][68][69] A trial of oral iron may however be considered in NDD-CKD patients based on the severity of their anemia, previous response to oral iron, venous access, and cost considerations. 61 Use of ESAs increases utilization of iron stores for hematopoiesis; they should only be used after functional or absolute iron deficiency has been corrected.…”

Intravenous iron: do we adequately understand the short‐ and long‐term risks in clinical practice?

“…The frequencies vary greatly, depending on the type of study performed. Brief descriptions of the studies in Table II 4,5,21,[37][38][39][40][41][42][43][44] follow in the paragraphs below, according to the type of study. Retrospective studies based on figures reported to centralized databases Fletes et al 4 analysed data from the clinical variance reports of Fresenius Medical Care North America (which distributes dialysis equipment).…”

“…Sivakumar et al 43 retrospectively reviewed charts of patients on various types of dialysis, for various ADEs. Only one patient developed a suspected anaphylactic reaction ('collapse') requiring active medical intervention for recovery.…”