Rienso: new parenteral iron therapy for anaemia in CKD

PHARMACOLOGY

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

CLINICAL STUDIES

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

Haemoglobin increase

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

Well tolerated

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

References:

1. Rienso Summary of Product Characteristics, June 2012
2. Provenzano R et al. Clin J Am Soc Nephrol 2009; 4: 386-93.
3. Spinowitz BS et al. J Am Soc Nephrol 2008; 19: 1599-1605.
4. Singh A et al. Am J Kidney Dis 2008; 52: 907-15.

View Rienso drug record
 
Further information: Takeda

Follow MIMS on Twitter