Take IV Iron Therapy to a proven place: No dextrans. No bolded or black box warnings. No test dose!





The National Kidney Foundation (NFK) publishes guidelines for optimizing care of patients with kidney disease. Since 1997 these guidelines, created through the NFK-Kidney Disease Outcomes Quality Initiative (NFK-KDOQI™), have served as an essential source of evidence-based clinical practice information. Below are some highlights from the 2006/2007 updated KDOQI guidelines focusing on anemia in CKD:

Target levels
2006/2007 NFK-KDOQI Guideline Recommended Levels



Monitoring Iron Status
Results from the iron status tests, Hb, and ESA dose should be interpreted together to guide iron therapy. Recommended frequency of testing includes:

  • Monthly for patients initiating ESA therapy
  • Every 3 months for patients who have achieved target Hb range or are receiving IV iron therapy
  • More frequent:
    - Recent bleeding
    - Initiation of iron therapy
    - After surgery or hospitalization
    - Evaluation for ESA hyporesponse
    - Monitoring response after a course of IV iron
    - Correction of a less-than-target Hb level during ongoing ESA therapy


Administration of Supplemental Iron
Oral iron

  • Appropriate in NDD and PDD-CKD patients
  • Daily dose of elemental oral iron is approximately 200 mg in adults
  • Unlikely to maintain target iron indices in ESA-treated patients


IV Iron

  • Maintain target Hb level
  • Avoid storage iron depletion
  • Prevent iron deficiency erythropoiesis


*When ferritin level is > 500 ng/mL, decisions regarding IV iron administration should weigh ESA responsiveness, Hb, TSAT, and patient's clinical status. In particular, when ferritin is >500 while concurrently measured TSAT is <20%, iron deficiency may be present and a course of iron treatment may be considered.
American Regent. Enriching the lives of anemia patients. ™

IMPORTANT SAFETY INFORMATION:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance

(7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).


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