Abstract: FR-PO522

Review of Safety of IV Iron Therapy in Patients with Non-Dialysis CKD (CKD-ND)

Session Information

Category: Chronic Kidney Disease (Non-Dialysis)

  • 304 CKD: Epidemiology, Outcomes - Non-Cardiovascular

Authors

  • Meyer, Vikki M, HEY Hospitals, HULL, United Kingdom
  • Cooper, Richard Peter, Hull and East Yorkshire NHS Trust, Hull, United Kingdom
  • Bhandari, Sunil, Hull and East Yorkshire Hospitals NHS Trust and Hull York Medical School, East Yorkshire, Hull, United Kingdom
Background

Anaemia in patients with Chronic Kidney Disease not on dialysis therapy (CKD-ND) is common, and often necessitates the use of intravenous iron products to correct both functional and absolute iron deficiency and iron deficiency anaemia. There has been a large increase in use but concerns on safety have been correctly raised. JAMA highlighted a high rate of ‘anaphylaxis’ in parenteral iron administration and mortality related to anaphylaxis. Short term reactions are known to occur including acute anaphylactic and labile iron reactions (Fishbane effect) while longer term effects include elevated oxidative stress, possible increased risk of infections, and risk of iron overload.

Methods

This retrospective observational single-centre study, examined our experience of short term adverse effects with parenteral iron administration in CKD-ND using two preparations, MonoFer and CosmoFer. Our database recorded patients’ demographics, iron administered, baseline haemoglobin, iron parameters, clinical observations and side effects.
A total of 909 doses of MonoFer (1g-1.5g) and 870 doses of CosmoFer (1g-1.5g) were administered to 1271 patients with a mean age of 68.67y for CosmoFer and 65.56y for MonoFer, with no known allergies.

Results

CosmoFer: a total of 1 anaphylactic event in 870 doses (0.11%) occurred and infusion discontinued due to hypotension and respiratory distress. Other reactions consisted of headache (2), diarrhoea (1), vomiting (1), flushing (2) and numbness (1). MonoFer: a total of 5 reactions, vomiting (1), lethargy (1), constipation (1), flare up eczema (1) and one collapse requiring discontinuation of infusion, hydrocortisone, oxygen support, but no other intervention. Reactions requiring drug discontinuation were CosmoFer, 1 in 870 doses; and MonoFer, 1 in 909 doses, which incidentally was the same patient in both cases.

Conclusion

Hyper-sensitivity reactions can occur in anyone receiving intravenous iron and at any time. Vigilance during administration is important and in the immediate 30 minutes following the infusion as per EMA guidelines. At present the balance between the benefits and the risks remains in favour of iron administration and patients should be reassured until new data is available but care should be taken. More studies are required to delineate the short and longer term safety of iron therapy.

Funding

  • Government Support - Non-U.S.