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Early Identification

Prevalence

How prevalent is IDA in CKD?

Learn more about the prevalence of iron deficiency anemia.

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

Early evaluation of anemia in CKD is important15,18-20

Early testing of chronic kidney disease (CKD) populations at risk for iron deficiency anemia (IDA) is important.15,18-20

  • Evidence demonstrates that iron deficiency can occur as early as CKD Stage 215,18-20
  • The National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI™) recommends anemia evaluation as early as CKD Stage 337
  • Underlying causes of anemia must be evaluated prior to selecting appropriate treatment7,37

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 2000, 2006, and 2007.7,38

  • Clinical practice guidelines are largely 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 recommendations7

Initial Anemia Assessment

Recommendations:

  • Consider evaluating hemoglobin (Hgb) and other iron parameters in combination before initiating any anemia treatment
  • Complete blood count (CBC), Hgb concentration, red blood cell (RBC) indices (such as mean corpuscular hemoglobin [MCH], mean corpuscular volume [MCV], mean corpuscular hemoglobin concentration [MCHC]), white blood cell count, and differential and platelet count
  • Absolute reticulocyte count
  • Serum transferrin saturation (TSAT),
  • 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 concentration thresholds:
    • <13.5 g/dL in adult males
    • <12.0 g/dL in adult females

aMore 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)38

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 harm
  • 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

Guideline38:

  • 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.38

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 performed:
    • 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 therapy

It is important to evaluate patients based on all clinical data due to the limitations of iron status tests.34


NCCN® guidelines and recommendations39,a

The National Comprehensive Cancer Network® (NCCN®) guidelines describe CKD as a potential comorbidity and that the causes of anemia may be multifactorial. When evaluating anemia, consider:

  • Basic evaluation for possible causes of anemia when Hgb is ≤11 g/dL or ≥2 g/dL below baseline
  • IV or oral iron products are recommended if absolute iron deficiency is present (ferritin <30 ng/mL and TSAT <15%)
    • NCCN guidelines recommend intravenous (IV) iron therapy for supplementation and suggest it has superior efficacy to oral iron, which has been more commonly used but is less effective
  • Consider IV iron supplementation for patients presenting with functional iron deficiency (ferritin ≤800 ng/mL and TSAT <20%), who are also receiving ESAs

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

aAdapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Cancer- and Chemotherapy-Induced Anemia V.1.2012. © 2011 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES™, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
KDOQI is a trademark of the National Kidney Foundation.
NCCN is a registered trademark of the National Comprehensive Cancer Network.

For the treatment of iron deficiency anemia (IDA) in adults with chronic kidney disease (CKD)

Important Safety Information for Feraheme (ferumoxytol) Injection

Indication and contraindication

Feraheme (ferumoxytol) Injection is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.

Warnings and precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic-type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. 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. Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. 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.

Post-marketing safety experience

The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.