What is the recommended Venofer (iron sucrose) dosing regimen for a patient with iron deficiency anemia?

Venofer (Iron Sucrose) Dosing for Iron Deficiency Anemia

Administer Venofer 200 mg intravenously per infusion over 15-30 minutes, repeated 2-3 times weekly until reaching a total cumulative dose of 1000 mg for most patients, with the exact total dose determined by body weight and hemoglobin level. 1

Standard Dosing Regimens by Clinical Setting

Non-Dialysis Dependent Patients (Most Common Scenario)

• Administer 200 mg undiluted as a slow IV injection over 2-5 minutes OR as an infusion diluted in maximum 100 mL of 0.9% NaCl over 15 minutes 1
• Give on 5 different occasions over a 14-day period for a total of 1000 mg 1
• Alternative high-dose regimen: 500 mg diluted in maximum 250 mL of 0.9% NaCl over 3.5-4 hours on Day 1 and Day 14 (limited experience with this approach) 1
• Maximum single dose: 200 mg per infusion 2, 3
• Maximum weekly dose: 500 mg 2

Hemodialysis Dependent Patients

• Administer 100 mg undiluted as slow IV injection over 2-5 minutes OR as infusion of 100 mg diluted in maximum 100 mL of 0.9% NaCl over at least 15 minutes 1
• Give per consecutive hemodialysis session, early during dialysis (generally within first hour) 1
• Usual total treatment course: 1000 mg 1

Peritoneal Dialysis Dependent Patients

• Give 3 divided doses within a 28-day period: 1
  • Two infusions of 300 mg each over 1.5 hours, 14 days apart
  • One infusion of 400 mg over 2.5 hours, 14 days after the second dose
• Dilute in maximum 250 mL of 0.9% NaCl 1

Total Dose Calculation Based on Patient Characteristics

For patients with hemoglobin 10-12 g/dL: 3

• Body weight <70 kg: 1000 mg total dose
• Body weight ≥70 kg: 1500 mg total dose

For patients with hemoglobin 7-10 g/dL: 3

• Body weight ≥70 kg: 2000 mg total dose

Administration Guidelines

Preparation and Infusion

• Each mL contains 20 mg of elemental iron 1
• For 200 mg dose: dilute in 100 mL of 0.9% NaCl and infuse over minimum 30 minutes 4
• For 300-500 mg doses: dilute in maximum 250 mL of 0.9% NaCl 2
• Start infusion slowly for first 5 minutes to monitor for reactions 2

Safety Monitoring

• No test dose required for iron sucrose (unlike iron dextran) 2, 3
• However, consider 25 mg test dose over 5 minutes in patients with history of IV iron sensitivities or multiple drug allergies 2, 3
• Monitor vital signs during and after infusion 2
• Have resuscitation equipment, IV epinephrine, diphenhydramine, and trained personnel immediately available 2, 3
• Observe patient for 15-60 minutes after administration 2

Contraindications and Precautions

Absolute Contraindications

• Active bacteremia 2, 3
• Known hypersensitivity to iron sucrose 1

Important Clinical Considerations

• Chronic infection alone is NOT an absolute contraindication if risk/benefit favors treatment 2
• Avoid in first trimester of pregnancy 5
• Use caution with active infections 5
• Increased adverse effects reported in patients with collagen diseases 2

Adverse Effects Profile

Common Side Effects (Well-Tolerated Overall)

• Hypotension, nausea, vomiting, diarrhea (most frequent systemic effects) 2
• Flushing, abdominal cramps, arthralgias/myalgias 2
• Hypersensitivity reactions occur in approximately 0.5% of patients 2, 3
• Anaphylaxis risk: exceedingly rare (<1:200,000 administrations) 3

Metabolic Complications

• Hypophosphatemia occurs in only 1% of iron sucrose patients (compared to 58% with ferric carboxymaltose) 2
• Monitor serum phosphate in patients receiving long-term or multiple high-dose infusions if risk factors exist 2

Management of Infusion Reactions

• For minor reactions: Stop infusion, switch to hydration fluid to keep vein open, monitor 2
• Most reactions are self-limiting and resolve spontaneously with continued monitoring 2
• After 15 minutes, rechallenge may be considered with careful monitoring 2
• If symptoms worsen or don't improve after 15 minutes, administer IV corticosteroid (hydrocortisone) 2
• For severe reactions (dyspnea, wheezing, hypotension, chest pain): Treat with IV epinephrine, diphenhydramine, and corticosteroids 2

Monitoring and Treatment Goals

Pre-Treatment Assessment

• Confirm iron deficiency with transferrin saturation (TSAT) <20% 3
• Ferritin <100 ng/mL in inflammatory conditions (or <30 ng/mL in non-inflammatory conditions) 4, 3

Post-Treatment Monitoring

• Target hemoglobin increase of at least 2 g/dL within 4 weeks 5, 3
• Monitor hemoglobin at baseline and 3-4 weeks post-infusion 5
• Target transferrin saturation ≥20% and serum ferritin ≥100 ng/mL 5
• Avoid iron overload by maintaining transferrin saturation <50% and serum ferritin <800 μg/L 3
• Avoid evaluating iron parameters within first 4 weeks after administration as circulating iron can interfere with assay results 3

Key Clinical Pitfalls to Avoid

• Do not exceed maximum single dose of 200 mg to minimize dose-related anaphylactoid reactions 2
• Do not exceed maximum weekly dose of 500 mg 2
• Do not administer during active bacteremia 2, 3
• Avoid systemic iron toxicity by not exceeding recommended maximum doses 2
• Do not dilute to concentrations below 1 mg/mL 1

Practical Considerations

Advantages of Iron Sucrose

• Well-established safety profile with relatively few serious adverse effects 2
• No test dose required (unlike iron dextran) 2, 3
• Lower hypophosphatemia risk compared to ferric carboxymaltose 2

Disadvantages

• Requires multiple visits (typically 4-7) to achieve full iron repletion 5, 2
• Newer formulations (ferric carboxymaltose, ferric derisomaltose) can deliver 1000 mg in single 15-minute infusion 5
• Maximum single dose limited to 200 mg (vs. 1000 mg for newer agents) 5, 2

Pediatric Dosing (≥2 Years of Age)

Hemodialysis Dependent (Maintenance Treatment)

• 0.5 mg/kg (not to exceed 100 mg per dose) every 2 weeks for 12 weeks 1
• Give undiluted by slow IV injection over 5 minutes OR diluted in 0.9% NaCl at concentration of 1-2 mg/mL over 5-60 minutes 1

Non-Dialysis or Peritoneal Dialysis Dependent on Erythropoietin (Maintenance Treatment)

• 0.5 mg/kg (not to exceed 100 mg per dose) every 4 weeks for 12 weeks 1
• Same administration methods as above 1

Treatment may be repeated if iron deficiency recurs in all patient populations. 1