Prevalence of IDA

Iron deficiency affects well over 50% of CKD patients with anemia

In 2002, Hsu et al analyzed data from the Third National Health and Nutritional Examination Survey (NHANES III) (n=15,837) and found low iron indices to be frequently present at all levels of reduced creatinine clearance (CrCl).¹⁸

• More than 50% of CKD patients with anemia were iron deficient, as indicated by serum ferritin <100 ng/mL or TSAT <20%

Percentage of anemic CKD patients with iron deficiency¹⁸

Adapted from Hsu et al. J Am Soc Nephrol. 2002.

A more recent major retrospective analysis published by Fishbane et al (n=34,782) in 2009 expanded on the Hsu study and found that low levels of iron were present in most patients with reduced creatinine clearance (CrCl), suggesting that iron deficiency may be extraordinarily common in non-dialysis dependent chronic kidney disease (NDD-CKD) patients.³⁸

• Previous studies have also found low iron indices at all levels of reduced CrCl. However, this data was collected prior to widespread use of erythropoiesis stimulating agents (ESAs) and prior to publication of the first National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI™) guidelines.¹⁸
• The purpose of Fishbane’s analysis was to fully examine the distribution of serum ferritin and transferrin saturation (TSAT) among individuals with CKD studied by the National Health and Nutritional Examination Survey (NHANES) program.³⁸
• By thoroughly analyzing NHANES III data (1988-1994) and subsequent NHANES 2-year data sets (1999 to 2000, 2001 to 2002, and 2003 to 2004), Fishbane found that³⁸:
  • Low iron tests—indicated by serum ferritin <100 ng/mL or TSAT <20%—were present in approximately 58% of men and approximately 72% of women with NDD-CKD, Stages 3 to 5 (CrCl <60 mL/min)
  • The percentage of patients with low iron tests did not significantly differ between CKD Stages 3, 4, or 5 (P=NS)

Percentage of NDD-CKD patients with low iron tests by CKD stage for combined NHANES cohorts³⁸

Additional findings from Fishbane

In addition to a high prevalence of iron deficiency, the study found that³⁸:

• Risk for anemia was generally unrelated to quartiles of mean serum ferritin
• Probability of anemia increased with progressively lower quartiles of TSAT
• Divergence between serum ferritin and TSAT may be due to the effects of inflammation
  • Analysis demonstrated a trend of increasing levels of C-reactive protein—an inflammatory marker—in CKD patients Stages 3 to 5

Fishbane findings of low levels of iron tests in majority of CKD patients further supported in recent study by Gotloib et al.¹⁹

In 2006, Gotloib and colleagues evaluated 47 CKD patients with Hgb <12 g/dL who also showed evidence of low iron tests.

• Patients underwent sternal bone marrow biopsy
• 98%, or 46 of 47 patients, had no evidence of iron deposits in bone marrow, indicating severe iron deficiency

Anemia awareness is critical because of the high prevalence of anemia in CKD. It is especially important to identify anemia and its causes early to select appropriate treatment.

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.