What is the recommended dose of Venofer (iron sucrose) for a patient with severe iron deficiency anemia?

From the Guidelines

For severe iron deficiency, the maximum single dose of Venofer (iron sucrose) that can be given to a patient should not exceed 200 mg, as indicated in the most recent and highest quality study 1. The standard regimen for Venofer administration is 200 mg given intravenously over 2-5 minutes or as an infusion over 15-30 minutes, administered 5 times over a 14-day period.

• Alternative dosing includes 300-400 mg per session given less frequently, but not exceeding 600 mg in a single week, as per the guidelines 1.
• For hemodialysis patients, 100 mg can be given during each dialysis session.
• Patients should be monitored for hypersensitivity reactions during and after administration, particularly during the first few minutes, as anaphylaxis may occur, and resuscitation facilities should be available for all these agents when given intravenously 1. The treatment should be guided by hemoglobin levels, ferritin, and transferrin saturation measurements, with follow-up labs recommended 4-8 weeks after completing the course to assess response and determine if additional iron is needed.
• The incidence of side effects with ferric carboxymaltose are similar to other intravenous compounds (22e29%), but no anaphylaxis has been reported to date, however, Venofer has a more convenient administration regimen 1.
• The rise in Hb at 12 weeks is similar to that observed during oral iron therapy, but Venofer works by replenishing iron stores more rapidly than oral supplements, allowing for red blood cell production to resume 1.

From the FDA Drug Label

2 DOSAGE & ADMINISTRATION Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.

1. 2 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session [see How Supplied/Storage and Handling ( 16.2).]
2. 3 Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) Administer Venofer 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0. 9% NaCl over a period of 15 minutes.

The recommended dose of Venofer for severe iron deficiency is not explicitly stated in the provided drug labels. However, based on the available information, the following doses are recommended for different patient populations:

• Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD): 100 mg per consecutive hemodialysis session, with a usual total treatment course of 1000 mg 2.
• Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD): 200 mg on 5 different occasions over a 14-day period 2. It is essential to note that the dosing for severe iron deficiency is not explicitly stated, and the treatment course may be repeated if iron deficiency reoccurs. It is crucial to consult the full prescribing information and follow the recommended dosage and administration guidelines for each specific patient population. 2 2

From the Research

Venofer Dosage for Severe Iron Deficiency

• The dosage of Venofer (iron sucrose) for severe iron deficiency is not explicitly stated in the provided studies, but we can look at the dosages of other intravenous iron preparations for guidance.
• According to the study 3, high doses of intravenous iron are required for certain clinical situations, with levels of 1500 mg in nondialysis-dependent chronic kidney disease and up to 3600 mg in inflammatory bowel disease.
• The study 4 describes the use of high-dose intravenous iron (ferric carboxymaltose) as the first-choice therapy in outpatients with severe iron deficiency anemia, with a median dose of 1500 mg.
• The study 5 mentions that modern iron formulations can be infused at different doses and allow correction of total iron deficit with single or repeated doses in 1-2 weeks, depending on the specific formulation.

Factors Affecting Dosage

• The dosage of intravenous iron may depend on the severity of iron deficiency, the presence of inflammation, and the patient's weight and medical history.
• The study 6 compares the efficacy and safety of high-dose intravenous iron and oral iron in treating iron deficiency anemia, and found that high-dose intravenous iron quickly boosts hemoglobin levels and improves iron metabolism parameters.
• The study 7 provides a consensus review on the use of intravenous iron in routine clinical practice, and emphasizes the importance of individualized treatment selection and monitoring for potential side effects.

Potential Side Effects

• The studies mention that intravenous iron therapy is associated with a risk of severe infusion reactions, as well as hypophosphatemia and other biochemical changes that can cause severe clinical complications.
• The study 5 highlights the importance of individual selection of the appropriate iron therapy and evaluation of treatment response to safely deliver improved outcomes through intravenous iron therapies.