IDA in CKD

The changing paradigm of anemia management in CKD

Iron deficiency anemia (IDA) is a condition frequently diagnosed in patients with chronic kidney disease (CKD)—one that has proven to be much more prevalent than previously thought.^11,12 Increasing awareness about current issues in the diagnosis and treatment of IDA is critical to improving anemia management practices, especially as new IDA treatments become available.

• Anemia is prevalent in both non-dialysis dependent CKD (NDD-CKD) patients and dialysis dependent CKD (DD-CKD) patients across all stages of CKD^11,13-18
• Iron deficiency is under-recognized and undertreated among NDD-CKD patients with anemia
  • Studies have demonstrated that high proportions of NDD-CKD patients with anemia are iron deficient, indicating IDA remains significantly under-recognized and undertreated^16,18-23
• IDA starts early in CKD
  • Evidence shows that IDA (transferrin saturation [TSAT] <20% or serum ferritin <100 ng/mL) can occur as early as CKD Stage 2^12,19,24-28

To review the role iron plays in erythropoiesis, see The Importance of Iron.

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.