Indications for Venofer (Iron Sucrose)
Venofer is FDA-approved for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD), including those on hemodialysis, peritoneal dialysis, and non-dialysis-dependent CKD. 1
Primary FDA-Approved Indication
Treatment of iron deficiency anemia in chronic kidney disease patients across all stages of renal disease 1:
- Hemodialysis-dependent CKD patients receiving erythropoiesis-stimulating agents (ESAs) 2
- Peritoneal dialysis patients with documented iron deficiency 2
- Non-dialysis-dependent CKD patients (stages 3-5) with IDA 3
Clinical Context for Use in CKD
Iron deficiency is a major contributor to anemia in CKD, particularly when GFR falls below 60 mL/min/1.73m² and becomes especially prevalent when GFR is below 30 mL/min/1.73m² 2. The rationale for intravenous iron in CKD includes:
- Oral iron fails to maintain adequate iron stores in most hemodialysis patients, resulting in persistent moderate anemia that increases morbidity and mortality 2
- Erythropoiesis requires both iron and erythropoietin, and iron supplementation is essential to ensure adequate response to ESA therapy 2
- Intravenous iron is required if oral iron is not tolerated or ineffective, or if dialysis has been commenced 2
Defining Iron Deficiency in CKD
Absolute iron deficiency in CKD is defined differently than in the general population 2:
- Transferrin saturation ≤20% AND
- Serum ferritin ≤100 μg/L (predialysis and peritoneal dialysis patients) OR
- Serum ferritin ≤200 μg/L (hemodialysis patients)
Functional iron deficiency occurs when iron stores cannot meet the demands of ESA-stimulated erythropoiesis, even with adequate ferritin levels 2.
Off-Label Uses Supported by Guidelines
While not FDA-approved for these indications, guideline societies support intravenous iron sucrose use in:
Inflammatory Bowel Disease (IBD)
- Approximately one-third of patients with active IBD have iron deficiency 2
- Intravenous iron is preferred when oral iron is not tolerated or ineffective 4
- Iron sucrose is an established treatment for IDA in IBD patients who need rapid iron supply 4
Other Conditions
Iron sucrose has demonstrated efficacy in 4:
- Pregnancy (second and third trimester)
- Postpartum period
- Heavy menstrual bleeding
- Cancer-related anemia (particularly when oral iron is ineffective or not tolerated)
Clinical Outcomes Supporting Use
Effective treatment of anemia in CKD improves survival, decreases morbidity, and increases quality of life 2. Specifically:
- Iron sucrose rapidly increases hemoglobin, ferritin, and transferrin saturation levels with an acceptable safety profile 5
- Intravenous iron administration is superior to oral iron therapy in managing non-dialysis-dependent CKD patients with anemia and low iron indices 3
- Treatment maintains hemoglobin concentrations effectively in hemodialysis patients 6
Key Clinical Pitfalls to Avoid
Do not administer Venofer to patients with 1:
- Known hypersensitivity to iron sucrose (absolute contraindication)
- Iron overload (regularly monitor hematologic responses)
- Active bacteremia (withhold during active infection, though this is not an absolute FDA contraindication) 7