Safety and tolerability of ferric carboxymaltose (FCM) for treatment of iron deficiency in patients with chronic kidney disease and in kidney transplant recipients

Clin Nephrol. 2009 Feb;71(2):125-9. doi: 10.5414/cnp71125.

Abstract

Background: Iron deficiency is common in patients with chronic kidney disease and in kidney transplant recipients.

Patients and methods: We analyzed the safety and tolerability of the new intravenous iron preparation ferric carboxymaltose (FCM) in these two patient groups. Adverse events after administration of the drug were assessed by using a questionnaire. Vital signs and laboratory data were collected before and after the application of FCM. A total of 46 FCM doses were applied to 44 patients (17 with chronic kidney disease and 27 kidney transplant recipients) either as single injection of 100 or 200 mg (n = 42) or as short infusion with up to 500 mg (n = 4).

Results: Mild and transient adverse events (metallic taste, headache, dizziness) occurred in six patients. The estimated glomerular filtration rate remained unchanged by the FCM administration.

Conclusion: We conclude that safety and tolerability of FCM were excellent. Compared with other intravenous iron preparations the considerably shorter administration time of FCM allows to save time and to reduce costs.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anemia, Iron-Deficiency / drug therapy*
  • Anemia, Iron-Deficiency / etiology
  • Female
  • Ferric Compounds / administration & dosage
  • Ferric Compounds / adverse effects
  • Ferric Compounds / therapeutic use*
  • Humans
  • Infusions, Intravenous
  • Kidney Failure, Chronic / complications*
  • Kidney Transplantation*
  • Male
  • Maltose / administration & dosage
  • Maltose / adverse effects
  • Maltose / analogs & derivatives*
  • Maltose / therapeutic use
  • Prospective Studies
  • Statistics, Nonparametric
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Ferric Compounds
  • ferric carboxymaltose
  • Maltose