Postoperative anemia is associated with increased morbidity and mortality in patients who underwent surgery. Also anemia is a common feature during sepsis. We investigate the safety and efficacy of intravenous iron isomaltoside 1000 (Monofer®) in patients undergoing elective urologic surgery or urosepsis. 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.

The study was conducted with medical record review of the patients with postoperative anemia undergoing elective urologic surgery or urosepsis in multicenter hospital. Patients received a single intravenous iron isomaltoside (IIM) and were evaluated haemoglobin (Hb) level before and after administration of IIM. Safety data included adverse effects and hypersensitivity reactions. In addition, the patients were divided into three groups receiving IIM 200mg, 400mg, and 600mg to compare Hb changes before and after the administration of IIM.

Mean age of patients was 67 years old and they were 52 men and 30 women. There was significant difference between pre-treatment Hb and post-treatment Hb according to the type of the surgery after administration (p=0.01) of IIM in patients with postoperative anemia. Mean preoperative Hb before administration of IIM was 8.5 g/dl and 9.9 g/dl after administration (p=0.006) in patients with urosepsis. Mean preoperative Hb changed from 10 g/dl to 11 g/dl after administration (p<0.001) of IIM in total cohort.

There were no differences in side effects due to administration of intravenous IIM. iron isomaltoside 1000 can be administered in high doses without a test dose due to its low immunological activity and low risk of free iron related toxicity. New iron preparations should ideally be capable of delivering a wide dosing range to allow a single visit iron correction dose with no requirement for a test dose, a fast infusion, and minimal potential side effects including low catalytic/labile iron release and negligible risk of anaphylaxis.

A single perioperative intravenous IIM 1000 significantly increased the Hb level in patients with anemic state underwent urologic elective surgery. Moreover, it can be considered on potential clinical benefits of anemia treatment with septic condition.