Ferumoxytol is a parenteral colloidal iron-carbohydrate complex.1 A carbohydrate shell isolates the bioactive iron to minimise its immunogenicity, which may allow administration of higher doses than other intravenous iron preparations.1,2
The safety and efficacy of intravenous ferumoxytol were assessed in three open-label studies involving 837 patients with CKD and iron-deficiency anaemia. Patients were randomised to receive either ferumoxytol (two 510mg injections 2–8 days apart) or oral iron (200mg elemental iron daily for 21 days). Patients in studies 1 and 2 were not receiving haemodialysis while those in the third study were.1
In the first study (n=304), ferumoxytol was associated with a significant increase in haemoglobin at day 35 (the primary efficacy endpoint) compared with oral iron (mean increase 0.82g/dL versus 0.16g/dL; (p<0.0001). In addition, more than twice as many ferumoxytol patients achieved a ≥1g/dL increase in haemoglobin at day 35 (39% versus 18.4% of placebo patients). Similar findings were reported in the other two studies.1–3
Ferumoxytol was well tolerated in all three studies.1–3 In a double-blind cross-over safety study involving 750 anaemic patients with CKD stages 1–5 and 5D, ferumoxytol was well tolerated in all stages of CKD with similar rates of adverse events to placebo.4
- Rienso Summary of Product Characteristics, June 2012
- Provenzano R et al. Clin J Am Soc Nephrol 2009; 4: 386-93.
- Spinowitz BS et al. J Am Soc Nephrol 2008; 19: 1599-1605.
- Singh A et al. Am J Kidney Dis 2008; 52: 907-15.