Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia

  • D.B. B
  • L.T. G
  • Bregman D
 et al. 
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Abstract

Erythropoiesis may be limited by absolute or functional iron deficiency or when chronic inflammatory conditions lead to iron sequestration. Intravenous iron may be indicated when oral iron cannot address the deficiency. Ferric carboxymaltose (FCM) is a nondextran iron preparation recently approved in the United States for intravenous treatment of iron deficiency anemia (IDA) in adult patients with intolerance or unsatisfactory response to oral iron or with nondialysis-dependent chronic kidney disease. The full dose is two administrations of up to 750 mg separated by at least 7 days (up to 1500 mg total). FCM can be injected in 7-8 min or diluted in saline for slower infusion. The efficacy and safety of this dose was established in two prospective trials that randomized over 3500 subjects, 1775 of whom received FCM. One trial showed similar efficacy of FCM to an approved intravenous iron regimen (1000 mg of iron sucrose) in 2500 subjects with chronic kidney disease and additional cardiovascular risk factors. The other trial showed superior efficacy of FCM to oral iron in subjects with IDA due to various etiologies (e.g. gastrointestinal or uterine bleeding). In these trials, there was no significant difference between FCM and comparator with respect to an independently adjudicated composite safety endpoint, including death, myocardial infarction, or stroke. A database of 5799 subjects exposed to FCM provided a safety profile acceptable for regulatory approval. Mechanistic studies demonstrated that the transient, asymptomatic reduction in serum phosphate observed following FCM administration results from induction of fibroblast growth factor 23, which in turn induces renal phosphate excretion. An elevated hepcidin level may identify patients with IDA who will not respond to oral iron but will respond to FCM. The ability to administer FCM in two rapid injections or infusions will likely be viewed favorably by patients and healthcare providers. (copyright) The Author(s), 2014.

Author-supplied keywords

  • abdominal pain
  • acute respiratory failure
  • anaphylaxis
  • angioneurotic edema
  • arthralgia
  • backache
  • cardiovascular risk
  • cerebrovascular accident
  • chill
  • chronic kidney disease
  • congestive heart failure
  • constipation
  • diarrhea
  • dizziness
  • drug efficacy
  • drug fatality
  • drug hypersensitivity
  • drug induced headache
  • drug safety
  • dysgeusia
  • dyspnea
  • erythema
  • faintness
  • ferric carboxymaltose
  • ferritin
  • ferrous sulfate
  • fever
  • fibroblast growth factor 23
  • heart arrhythmia
  • heart infarction
  • hemoglobin
  • hemolytic anemia
  • hepcidin
  • high risk patient
  • hot flush
  • human
  • hypertension
  • hypotension
  • injection site discoloration
  • injection site extravasation
  • injection site irritation
  • injection site pain
  • iron deficiency anemia
  • iron saccharate
  • multicenter study (topic)
  • nausea
  • paresthesia
  • phase 2 clinical trial (topic)
  • phase 3 clinical trial (topic)
  • phosphate
  • phosphate blood level
  • phosphate excretion
  • postmarketing surveillance
  • priority journal
  • pruritus
  • randomized controlled trial (topic)
  • rash
  • review
  • rhabdomyolysis
  • tachycardia
  • thorax pain
  • transferrin
  • treatment response
  • unstable angina pectoris
  • urinary excretion
  • urticaria
  • vomiting
  • wheezing

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Authors

  • Bregman D.B.

  • Goodnough L.T.

  • David B Bregman

  • Lawrence T Goodnough

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