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: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to VenoferŪ or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving VenoferŪ. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with VenoferŪ administration.

Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.

In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of VenoferŪ with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to VenoferŪ reported by ≥5% of VenoferŪ exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to VenoferŪ 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 post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to VenoferŪ administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).


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