What is the maximum recommended dose of Venofer (iron sucrose)

Maximum Recommended Dose of Venofer (Iron Sucrose)

The maximum recommended single dose of Venofer (iron sucrose) is 200 mg, with a maximum weekly dose of 500 mg according to FDA guidelines. 1

Dosing Guidelines for Iron Sucrose

• The concentration of elemental iron in Venofer is 20 mg/ml 1
• For single dose administration:
  • Maximum single dose: 200 mg 1
  • Minimum infusion time for maximum dose: 15 minutes (FDA) 1
  • Minimum injection time for maximum dose: 2-5 minutes (FDA) 1
• For weekly dosing:
  • Maximum weekly dose: 500 mg 1
  • Individual doses above 300 mg are not recommended 1

Administration Methods

• Iron sucrose can be administered by:
  • IV infusion: 200 mg over 60 minutes 1
  • IV push: 200 mg over 2-5 minutes 1
  • Repeated dosing every 2-3 weeks 1

Safety Considerations

• Test doses are not required for iron sucrose, unlike iron dextran 1
• However, test doses (25 mg slow IV push) are strongly recommended if patients have:
  • Previous sensitivities to iron dextran or other IV iron preparations 1
  • Multiple drug allergies 1
• Patients with active infection should not receive IV iron therapy 1

Evidence for Dose Limitations

• Studies have demonstrated that higher doses can lead to adverse events:
  • A 500 mg dose administered over 2 hours resulted in adverse reactions in 8 of 22 patients (36%), including dizziness, hypotension, and nausea 2
  • A 400 mg dose over 2 hours caused hypotension, nausea, and lower back pain in 2 of 35 patients 2
  • Doses of 200 mg and 300 mg administered over 2 hours were found to be safe with no adverse reactions 2

Clinical Applications

• For treatment of iron deficiency in hemodialysis patients:
  • A common regimen is 100 mg IV during 10 consecutive hemodialysis sessions (replacement regimen) 3
  • For maintenance therapy: 100 mg IV weekly for 10 weeks 3
• In cancer patients receiving ESAs:
  • Individual doses above 300 mg are not recommended 1
  • Maximum total dose = 1000 mg 1

Important Considerations

• Iron sucrose has been shown to be effective and safe when administered within recommended dosing parameters 3, 4
• The safety profile is favorable compared to some other IV iron preparations, particularly in patients with previous iron dextran sensitivity 4
• Exceeding recommended doses significantly increases the risk of adverse events including hypotension, nausea, dizziness, and back pain 2

Remember that while higher single doses (300-500 mg) have been studied, the official FDA-approved maximum single dose remains 200 mg with a maximum weekly dose of 500 mg 1.