title: Safety and tolerability of ferric carboxymaltose (FCM) for treatment of iron deficiency in patients with chronic kidney disease and in kidney transplant recipients.
abstract: BACKGROUND
  Iron deficiency is common in patients with chronic kidney disease and in kidney transplant recipients.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Clinic for Nephrology, University Hospital, Zürich, Switzerland.
authors.forename: A-C
authors.initials: AC
authors.lastname: Grimmelt
authors.forename: C D
authors.initials: CD
authors.lastname: Cohen
authors.forename: T
authors.initials: T
authors.lastname: Fehr
authors.forename: A L
authors.initials: AL
authors.lastname: Serra
authors.forename: R P
authors.initials: RP
authors.lastname: Wuethrich
mesh_terms: D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D007676:Kidney Failure, Chronic / Q000150:complications*; D016030:Kidney Transplantation; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; C522335:ferric carboxymaltose; D008320:Maltose