Publications

The following articles have been selected for their relevance to the epidemiology, identification, and clinical management of anemia in chronic kidney disease (CKD) with Feraheme. Check back periodically for updates to this bibliography as new articles appear in clinical literature. Be sure to review the Feraheme full Prescribing Information.

Safety of ferumoxytol in patients with anemia and CKD
Singh A, Patel T, Hertel J, Bernardo M, Kausz A, Brenner L. Am J Kidney Dis. 2008;52(5):907-915.

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Ferumoxytol for treating iron deficiency anemia in CKD
Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJG. J Am Soc Nephrol. 2008;19(8):1599-1605.

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Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients
Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJG. Clin J Am Soc Nephrol. 2009;4(2):386-393.

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Physicochemical properties of ferumoxytol, a new intravenous iron preparation
Balakrishnan VS, Rao M, Kausz AT, et al. Eur J Clin Invest. 2009;39(6):489-496.

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Important Safety Information

Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

Warnings and precautions

In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when personnel and therapies are readily available for the treatment of hypersensitivity reactions. 1.9% (33/1,726) of Feraheme-treated subjects experienced hypotension. Please monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

Adverse reactions

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Please see full Prescribing Information for Feraheme.