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

Venofer Dosing for Severe Iron Deficiency Anemia

For severe iron deficiency anemia, administer Venofer 200 mg intravenously over 10-15 minutes, given 5 times over a 14-day period (total 1000 mg), with additional doses calculated based on the patient's total iron deficit using the Ganzoni formula or simplified weight-based approach. 1, 2

Standard Dosing Regimen

The FDA-approved dosing for non-dialysis patients is 200 mg administered as a slow intravenous injection over 2-5 minutes or as an infusion diluted in 100 mL of 0.9% NaCl over 15 minutes, repeated on 5 different occasions over a 14-day period (total 1000 mg). 1 This represents the most straightforward approach for most patients with severe iron deficiency anemia. 2

• Each dose contains 200 mg of elemental iron (10 mL of solution at 20 mg/mL). 1
• The maximum single dose is 200 mg for non-dialysis patients. 3, 1
• Bolus dosing over 10 minutes is licensed and more convenient than prolonged infusions. 3

Calculating Total Iron Requirements

Before initiating therapy, calculate the patient's total iron deficit to determine if additional doses beyond the standard 1000 mg are needed. 2

Ganzoni Formula Method:

• Total iron deficit (mg) = Body weight (kg) × [target Hb - actual Hb (g/dL)] × 0.24 + 500 mg 2
• The additional 500 mg accounts for iron store repletion. 2

Simplified Weight-Based Approach (for patients ≥50 kg):

• Hemoglobin 10-12 g/dL (women) or 10-13 g/dL (men): 1000-1500 mg total iron 2
• Hemoglobin 7-10 g/dL: 1500-2000 mg total iron 2
• Add 500 mg if Hb <7.0 g/dL 2

Translating Total Deficit to Number of Doses:

• 1000 mg total = 5 doses of 200 mg 2
• 1500 mg total = 7-8 doses of 200 mg 2
• 2000 mg total = 10 doses of 200 mg 2

Alternative High-Dose Regimen

For patients requiring rapid repletion, the FDA label describes limited experience with 500 mg diluted in 250 mL of 0.9% NaCl infused over 3.5-4 hours on Day 1 and Day 14. 1 However, this approach has less supporting data than the standard 200 mg dosing. 1

A single high-dose regimen of 7 mg iron/kg body weight (not exceeding 500 mg) infused over 3.5 hours has been studied in patients with gastrointestinal bleeding and found to be safe and well-tolerated. 4

Administration Requirements

Resuscitation equipment must be immediately available during all infusions due to the risk of anaphylaxis, though serious reactions are rare (0.6-0.7% with iron preparations). 3, 2

• No test dose is required for iron sucrose, unlike iron dextran. 3, 1
• Administer undiluted over 2-5 minutes or diluted in 0.9% NaCl over 15 minutes. 1
• Do not dilute to concentrations below 1 mg/mL. 1

Monitoring and Expected Response

Recheck hemoglobin, ferritin, and transferrin saturation at 4 weeks after completing the initial course. 2

• Expected response: Hemoglobin increase ≥2 g/dL within 4 weeks 2, 5
• Studies show 84-94% of patients respond with at least a 2 g/dL increase in hemoglobin. 5
• Mean hemoglobin increases of 3.3-4.6 g/dL have been documented. 5
• Ferritin levels should rise significantly (mean increase from 7.6 to 99 ng/mL in one study). 5

If target hemoglobin is not achieved, investigate for ongoing blood loss, malabsorption, chronic inflammation, or other causes of treatment failure. 2, 3

Safety Profile

Iron sucrose has an excellent safety profile with no moderate or serious adverse drug reactions in large studies administering over 500 infusions. 5 Common minor adverse events include hypotension, nausea, vomiting, pain, hypertension, dyspnea, pruritus, headache, and dizziness, occurring in 22-29% of patients. 3

• Iron sucrose is significantly better tolerated than oral iron, with only 4.5% discontinuation due to side effects versus 20.8% with oral iron sulfate. 6
• No anaphylaxis has been reported with iron sucrose in recent large trials, unlike iron dextran which carries a boxed warning. 3
• Safe in patients with previous iron dextran sensitivity or other drug allergies. 7

Critical Pitfalls to Avoid

The most common error is stopping after 2-3 doses when patients need 5 or more rounds to fully replete iron stores. 2 Many clinicians prematurely discontinue therapy once hemoglobin begins rising, but this fails to restore iron reserves. 2

• Do not administer oral iron simultaneously with IV iron therapy - this provides no additional benefit and increases side effects. 3
• Never give IV iron during active bacterial infection due to theoretical concerns about promoting bacterial growth. 3
• Do not exceed transferrin saturation >50% or ferritin >800 μg/L to avoid iron overload. 3
• Contraindicated in patients with evidence of iron overload or hemochromatosis. 1

When to Repeat Treatment

Venofer treatment may be repeated if iron deficiency recurs, as stated in the FDA label. 1 After completing the initial course and achieving target hemoglobin and ferritin levels, monitor patients periodically (every 3-6 months) for recurrence, especially if the underlying cause of iron loss has not been fully addressed. 3

For patients with chronic ongoing losses (e.g., menorrhagia, inflammatory bowel disease), maintenance therapy may be required, though specific regimens for this indication are not well-established in non-dialysis populations. 3, 6