Evaluating Serum Ferritin

Just how reliable is serum ferritin?

The usefulness of serum ferritin as an iron marker for the management of anemia in chronic kidney disease (CKD) is currently the subject of debate. When evaluating iron status tests, consider the following:

• Serum ferritin is an acute-phase reactant⁴³
• A low serum ferritin level (<200 ng/mL in dialysis dependent CKD [DD-CKD] patients or <100 ng/mL in non-dialysis dependent CKD [NDD-CKD] patients) can be a reliable indicator of iron deficiency⁴⁴
• Reduced levels of serum ferritin or transferrin saturation (TSAT) are present in most patients with CKD³⁸
• A normal to moderately high serum ferritin does not rule out iron deficiency or indicate adequate or excessive iron levels⁴⁴

There is currently no critical consensus on an upper threshold for serum ferritin.⁴⁴

For further information on other iron markers—including serum ferritin—see the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI™) clinical practice guidelines and recommendations for the identification of anemia in CKD.

KDOQI is a trademark of the National Kidney Foundation.

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.