Journal
DRUGS
Volume 72, Issue 15, Pages 2013-2022Publisher
ADIS INT LTD
DOI: 10.2165/11209880-000000000-00000
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Ferumoxytol is an intravenously administered iron preparation indicated in the EU and the US for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). It consists of superparamagnetic iron oxide nanoparticles coated with a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution that can be administered at relatively high dose by rapid intravenous injection. In phase III, randomized, controlled trials, two doses of ferumoxytol (510 mg iron/dose) given 2-8 days apart increased mean haemoglobin levels from baseline to week 5 significantly more than oral iron (200 mg/day for 21 days) in adult patients with iron deficiency anaemia and CKD stages 1-5. Ferumoxytol was more effective than oral iron both in patients with non-dialysis-dependent CKD and in those with haemodialysis-dependent CKD. Ferumoxytol was generally well tolerated in randomized controlled clinical trials. Most adverse events were mild or moderate in intensity; serious hypersensitivity or hypotensive reactions were uncommon. Local injection-site reactions were the most common system/organ-class adverse events in a pooled analysis of clinical studies and post-marketing experience.
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