Is ferric carboxymaltose injection (Injectafer) FDA approved for the treatment of iron deficiency anemia?

Updated: Aug 04, 2019
  • Author: James L Harper, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

In July 2013, the FDA approved ferric carboxymaltose injection (Injectafer) for the intravenous treatment of iron deficiency anemia in adults who either cannot tolerate or have not responded well to oral iron. The drug is also indicated for the treatment of iron deficiency anemia in adults with non–dialysis-dependent chronic kidney disease. Approval was based on two clinical studies in which the drug was given at a dose of 15 mg/kg body weight, up to a maximum of 750 mg, on two occasions at least 7 days apart, up to a maximum cumulative dose of 1500 mg of iron. [27, 28, 29]

A review of the safety of intravenous (IV) iron preparations, particularly in patients with CKD, by Kalra and Bhandari concluded that high molecular weight iron dextrans are associated with increased risks, so their use for IV therapy should be avoided. The second- and third-generation IV irons are considered equally efficacious in treating iron deficiency in equivalent doses, but iron isomaltoside seems to have a lower frequency of serious and severe hypersensitivity reactions. [30]


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