Venofer - Drug Monograph

Introduction

Venofer (iron sucrose injection) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia in patients who cannot tolerate or have inadequate response to oral iron therapy. It is a complex of ferric hydroxide in sucrose that provides a source of elemental iron for hemoglobin synthesis and iron storage.

Mechanism of Action

Venofer delivers iron directly to the reticuloendothelial system, where it dissociates into its component parts: iron and sucrose. The released iron binds to transferrin and is transported to erythroid precursor cells for incorporation into hemoglobin. The sucrose component is eliminated renally. This parenteral administration bypasses the gastrointestinal tract, allowing for more efficient iron utilization compared to oral preparations.

Indications

• Treatment of iron deficiency anemia in adult patients and pediatric patients 2 years and older
• Chronic kidney disease patients (both dialysis-dependent and non-dialysis dependent)
• Patients who have had unsatisfactory response to oral iron
• Patients who require rapid iron replenishment

Dosage and Administration

• Hemodialysis-dependent CKD patients: 100 mg IV over 2-5 minutes during dialysis
• Non-dialysis dependent CKD patients: 200 mg IV over 2-5 minutes on 5 separate occasions
• Peritoneal dialysis patients: 300 mg IV infusion over 1.5 hours on 2 separate occasions

• 0.5 mg/kg (max 100 mg) IV over 5 minutes

• May be administered undiluted by slow IV push (1 mL/min)
• May be diluted in 0.9% NaCl and infused over longer periods
• Test dose recommended (25 mg over 15 minutes) for first-time recipients

Pharmacokinetics

Contraindications

• Hypersensitivity to iron sucrose or any component of the formulation
• Evidence of iron overload
• Anemia not caused by iron deficiency
• Patients with known serious hypersensitivity to other parenteral iron products

Warnings and Precautions

• Hypersensitivity reactions: Potentially fatal anaphylactic-type reactions have occurred
• Hypotension: May occur with rapid administration
• Iron overload: Excessive dosages may lead to hemosiderosis
• Risk of infection: Iron may exacerbate existing infections
• Hepatic impairment: Use with caution in patients with liver dysfunction
• Cardiovascular disease: Monitor for hypotension in patients with cardiovascular instability

Drug Interactions

• Oral iron preparations: Reduced absorption of oral iron; avoid concurrent administration
• Dimercaprol: May form toxic complexes with iron
• ACE inhibitors: Possible increased risk of anaphylactoid reactions
• Chloramphenicol: May delay iron utilization

Adverse Effects

• Nausea (3.3%)
• Headache (2.5%)
• Dizziness (2.1%)
• Hypotension (2.1%)
• Vomiting (1.8%)
• Diarrhea (1.7%)
• Injection site reactions (1.5%)

• Anaphylaxis (<0.1%)
• Severe hypotension
• Syncope
• Chest pain
• Dyspnea
• Seizures

Monitoring Parameters

• Hematologic parameters (hemoglobin, hematocrit, reticulocyte count)
• Iron studies (ferritin, transferrin saturation)
• Vital signs during and after administration
• Signs of hypersensitivity reactions
• Blood pressure during infusion
• Hepatic and renal function
• Signs of iron overload with repeated dosing

Patient Education

• Report any signs of allergic reaction immediately (rash, itching, swelling, difficulty breathing)
• Understand that multiple doses are typically required
• Do not take oral iron supplements unless directed by healthcare provider
• Be aware of potential side effects including nausea, headache, and dizziness
• Inform all healthcare providers about Venofer treatment
• Keep all scheduled appointments for monitoring

References

1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2021. 2. Auerbach M, Ballard H. Clinical use of intravenous iron: administration, efficacy, and safety. Hematology Am Soc Hematol Educ Program. 2010;2010:338-347. 3. Macdougall IC, et al. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int. 1996;50(5):1694-1699. 4. Fishbane S, et al. The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis. 1996;28(4):529-534. 5. National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis. 2006;47(5 Suppl 3):S1-S146. 6. FDA-approved labeling and prescribing information for Venofer.