Is intravenous (IV) iron supplementation indicated for a patient with low iron saturation, hypoferritinemia (ferritin level of 12), and mild anemia (hemoglobin of 119)?

From the Guidelines

IV iron therapy is recommended for this patient with iron deficiency anemia, as indicated by the low ferritin (12 ng/mL), low iron saturation, and mild anemia (hemoglobin 119 g/L or 11.9 g/dL). The patient's laboratory values clearly indicate iron deficiency anemia that would benefit from prompt correction, as supported by the AGA clinical practice update on management of iron deficiency anemia 1.

Key Considerations

• The patient's ferritin level is low (12 ng/mL), indicating depleted iron stores, and hemoglobin is mildly low (119 g/L or 11.9 g/dL), suggesting a need for iron repletion.
• According to the expert review, IV iron is indicated if a patient cannot tolerate oral iron or if blood counts or iron stores do not improve with oral iron supplementation 1.
• IV iron should be used in situations where oral iron is unlikely to be effective, such as impaired absorption, although this specific scenario is not detailed in the patient's information provided.

Treatment Approach

• Suitable IV iron options include iron sucrose (typically 200-300 mg per session, up to 1000 mg total), ferric carboxymaltose (up to 1000 mg per dose), or iron dextran (total dose infusion), with the choice depending on availability, cost, and patient factors.
• Before administering IV iron, it is crucial to verify there are no contraindications such as active infection, first trimester pregnancy, or hypersensitivity to iron products.
• A test dose is recommended for iron dextran due to a higher risk of hypersensitivity reactions, as noted in the management guidelines 1.

Monitoring and Follow-Up

• After treatment, it is essential to monitor ferritin, hemoglobin, and iron saturation in 4-8 weeks to assess the response to IV iron therapy, as the goal is to improve these parameters and correct the iron deficiency anemia.
• The best practice advice also suggests using IV iron if the patient does not tolerate oral iron, ferritin levels do not improve with a trial of oral iron, or the patient has a condition in which oral iron is not likely to be absorbed 1.

From the FDA Drug Label

Serum Ferritin (ng/mL)199132NA Transferrin Saturation (%)8.52.86.6 In this patient population, only the Ferrlecit-treated group achieved increase in hemoglobin and hematocrit from baseline Ferrlecit at a dose of 1.5 mg/kg or 3.0 mg/kg (up to a maximum dose of 125 mg of elemental iron) in 25 mL 0.9% sodium chloride was infused intravenously over 1 hour during each hemodialysis session for eight sequential dialysis sessions.

The patient has low iron saturation and low ferritin levels (12 ng/mL), with a hemoglobin level of 119 g/dL. Based on the provided drug label, IV iron may be considered to increase hemoglobin and hematocrit levels. However, the label does not provide a clear indication for treatment with IV iron at the specific ferritin and hemoglobin levels mentioned.

• Key considerations:
  • The patient's ferritin level is significantly lower than the levels mentioned in the studies.
  • The patient's hemoglobin level is close to the lower limit of normal. Given the limited information and the fact that the patient's parameters do not exactly match those in the studies, it is unclear if IV iron is indicated. A conservative approach would be to consider alternative treatments or further evaluation before administering IV iron 2.

From the Research

Iron Deficiency and IV Iron Therapy

• The patient's lab results show low iron saturation, ferritin 12, and hemoglobin 119, indicating iron deficiency anemia 3.
• According to the study, iron deficiency is defined by low serum ferritin (typically <30 ng/mL) in individuals without inflammatory conditions or by transferrin saturation (iron/total iron binding capacity × 100) less than 20% 3.
• The patient's ferritin level is 12, which is below the threshold of 30 ng/mL, indicating iron deficiency.
• IV iron is indicated for patients with oral iron intolerance, poor absorption, chronic inflammatory conditions, ongoing blood loss, and during the second and third trimesters of pregnancy 3.
• However, the study also notes that IV iron should be used for individuals who do not tolerate or have impaired absorption of oral iron, those with ongoing blood loss, certain chronic inflammatory conditions, and during the second and third trimesters of pregnancy 3.

Diagnostic Criteria for Iron Deficiency

• The use of transferrin saturation as a diagnostic criterion for iron deficiency is supported by several studies 4, 5.
• A study published in the European journal of heart failure recommends defining iron deficiency by a TSAT <20% (as long as the serum ferritin level is <400 μg/L) 4.
• Another study published in Critical reviews in clinical laboratory sciences shows the benefit of using transferrin saturation in addition to ferritin in the diagnosis of iron deficiency 5.

Iron Markers and Hemoglobin

• A study published in The Journal of nutrition evaluated the sensitivity, specificity, and area under the receiver operating characteristics (ROC) curve of iron and hematologic indicators for iron deficiency 6.
• The study found that iron and hematologic indicators routinely used in clinical settings can under- or overestimate iron deficiency, suggesting that they are not ideal for iron deficiency surveillance 6.
• Another study published in Clinical kidney journal analyzed the associations between iron markers with hemoglobin and outcomes in peritoneal dialysis patients, and found that a ferritin/Hb ratio >2 was associated with increased risk of mortality 7.