ESAs and IV Iron

ESAs
Ferahame is effective independent of ESA use

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

KDOQI™-recommended treatment targets in patients receiving ESA therapy

The National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines provide a number of recommendations for ESA usage, including the frequency of Hgb monitoring, ESA dosage, and the route and frequency of ESA administration.23

  • Medical decisions regarding use of iron agents should be guided by results of iron tests together with Hgb levels and ESA dose, combined with analysis of trends for each parameter over time23
  • Making informed treatment decisions requires understanding the method of action of ESAs, and selecting those which best fit the patient, the patient-care setting, and the constraints of the healthcare delivery system from the range of choices that are known to be safe and effective23
  • Treatment with IV iron may reduce and/or delay ESA utilization23
KDOQI-recommended treatment targets for CKD patients on ESAs23

Provide sufficient iron to maintain the following indices of iron status during ESA treatment:

  • For NDD-CKD and peritoneal dialysis dependent CKD (PDD-CKD) patients
    • Serum ferritin >100 ng/mL
    • TSAT >20%
  • For DD-CKD patients
    • Serum ferritin >200 ng/mL
    • TSAT >20% or content of Hgb in reticulocytes (CHr) >29 pg/cell

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.