Early Identification

Early evaluation of anemia in CKD is critical

Prevalence
How prevalent is IDA
in CKD?

Learn more about the prevalence of iron deficiency anemia. >>

Please see other Important Safety Information and the Feraheme full Prescribing Information below.

Early testing of chronic kidney disease (CKD) populations at risk for iron deficiency anemia (IDA) is critical.

  • Evidence demonstrates that iron deficiency can occur as early as CKD Stage 211,15-17
  • The National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI™) recommends anemia evaluation as early as CKD Stage 341
  • Underlying causes of anemia must be evaluated prior to selecting appropriate treatment23

KDOQI clinical practice guidelines and recommendations

The NKF has issued clinical practice guidelines and recommendations for the identification of anemia in CKD. The KDOQI guidelines were originally published in 1997 and revised in 2001, 2006, and 2007.23,42

  • Clinical practice guidelines are evidence based and were issued when sufficient supporting data were available
  • Clinical practice recommendations were formulated based on consensus of expert opinion when limited data were available

Click on sections of the table below to learn more about specific KDOQI guidelines and recommendations for CKD.

KDOQI guidelines and recommendations23

Initial anemia assessment

Recommendations:

  • Consider hemoglobin (Hgb) and other iron parameters in combination before initating any anemia treatment
  • Complete blood count (CBC), Hgb concentration, red blood cell (RBC) indices (such as MCH, MCV, MCHC), white blood cell count, and differential and platelet count
  • Absolute reticulocyte count
  • Serum TSAT or content of Hgb in reticulocytes (CHr)
  • Serum ferritin

Hgb, TSAT or CHr, and ferritin should be tested together before initiating treatment since the combination of tests may provide greater insight into iron balance and distribution than any single test.

Evaluating Hgb in CKD

Recommendations:

  • Hgb testing should be carried out as early as CKD Stage 3
  • Hgb levels should be measured at least annuallya
  • Diagnosis of anemia should be made and further evaluation undertaken at the following Hgb threshold concentrations:
    • <13.5 g/dL in adult males
    • <12.0 g/dL in adult females

a More frequent Hgb surveillance will be needed for selected patients, including those with greater disease burden, unstable clinical course, or evidence of previous Hgb level decline.

Hgb levels in patients receiving erythropoiesis stimulating agents (ESAs)42

Recommendations:

  • Consider potential benefits and harm, with Hgb target not exceeding 13.0 g/dL
  • Selection of Hgb target and selection of Hgb level at which ESA therapy is initiated in the individual patient should include consideration of potential benefits and harms
  • In non-dialysis dependent CKD (NDD-CKD) and dialysis dependent CKD (DD-CKD) patients receiving ESA therapy, selected Hgb target should generally be in the range of 11.0 g/dL to 12.0 g/dL

Guideline42:

  • In NDD-CKD patients and DD-CKD patients receiving ESA therapy, the Hgb target should not be greater than 13.0 g/dL

Hgb target recommendations above do not apply to patients receiving iron therapy without the use of ESAs.41

Transferrin saturation (TSAT) and serum ferritin

Recommendations:

  • Along with Hgb, check as early as CKD Stage 3
  • Iron testing (Hgb, TSAT, and serum ferritin) should be performed23:
    • Every month during initial ESA therapy
    • At least every 3 months during stable ESA therapy or in patients with DD-CKD not treated with an ESA
  • Iron status, Hgb levels, and ESA dose should be considered together to guide iron therapy23

It is important to evaluate patients based on all clinical data due to the limitations of iron status tests.35

When assessing iron markers in combination, be aware of issues surrounding the evaluation of serum ferritin.

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.