Venofer (iron sucrose complex)

Dosage of iron sucrose is expressed in terms of mg of elemental iron. Iron sucrose injection contains the equivalent of 20 mg of elemental iron per mL.

For the treatment of iron deficiency anemia in hemodialysis-dependent adults with chronic kidney disease, the recommended dosage of iron sucrose is 100 mg administered by slow IV injection (over 2-5 minutes) or by IV infusion (diluted in a maximum of 100 mL of 0.9% sodium chloride injection) over at least 15 minutes during each consecutive hemodialysis session. Doses should be administered early during the dialysis procedure. A cumulative dose of 1 g of iron sucrose usually is required to achieve a favorable response in these patients.

In peritoneal dialysis-dependent adults with chronic kidney disease, a series of 3 doses of iron sucrose should be administered by IV infusion (diluted in a maximum of 250 mL of 0.9% sodium chloride injection) 14 days apart over a 28-day period. Patients should receive 300 mg of iron sucrose by IV infusion over 1.5 hours for the first 2 doses, followed by a dose of 400 mg administered over 2.5 hours.

For the treatment of iron deficiency anemia in adults with non-dialysis-dependent chronic kidney disease, the recommended dosage of iron sucrose is 200 mg administered by slow IV injection (over 2-5 minutes) or by IV infusion (diluted in a maximum of 100 mL of 0.9% sodium chloride injection and administered over 15 minutes) for a total of 5 doses; doses should be administered on 5 different occasions over a 14-day period. Iron sucrose also has been administered as a 2-dose regimen in a limited number of patients with non-dialysis-dependent chronic kidney disease; in this regimen, 500 mg of iron sucrose is administered by IV infusion (diluted in a maximum of 250 mL of 0.9% sodium chloride injection and administered over 3.5-4 hours) on days 1 and 14.

For iron maintenance therapy in children 2 years of age or older with hemodialysis-dependent chronic kidney disease, the recommended dosage of iron sucrose is 0.5 mg/kg (not to exceed 100 mg per dose) every 2 weeks for 12 weeks; doses may be administered undiluted by slow IV injection over 5 minutes or diluted in 25 mL of 0.9% sodium chloride injection and administered over 5-60 minutes.

For iron maintenance therapy in children 2 years of age or older with non-dialysis-dependent chronic kidney disease or peritoneal dialysis-dependent chronic kidney disease who are receiving supplemental erythropoiesis-stimulating agent (ESA) therapy, the recommended dosage of iron sucrose is 0.5 mg/kg (not to exceed 100 mg per dose) every 4 weeks for 12 weeks; doses may be administered undiluted by slow IV injection over 5 minutes or diluted in 25 mL of 0.9% sodium chloride injection and administered over 5-60 minutes.

If necessary, iron sucrose treatments may be repeated.

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Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Iron/Dimercaprol

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Dimercaprol can complex with iron, forming a chelation compound that is more toxic than iron alone.(1)

CLINICAL EFFECTS: Concurrent use of dimercaprol and iron may result in toxicity, especially renal toxicity.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Medicinal iron should not be administered to patients receiving dimercaprol.(1)

DISCUSSION: Because the dimercaprol-iron complex is more toxic than iron alone, especially to the kidneys, medicinal iron should not be administered to patients receiving dimercaprol.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to iron sucrose or any ingredient in the formulation.

• Chronic iron overload

• Hemosiderosis
• Hypotension
• Pneumonia

There are no moderate contraindications for this drug.

Adverse effects occurring in 2% or more of patients receiving iron sucrose injection include diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, extremity pain, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema.

Less Frequent

• Arteriovenous fistula thrombosis
• Chest pain
• Edema
• Hypertension
• Hypervolemia
• Hypotension
• Peripheral edema
• Upper respiratory infection

Rare or Very Rare

• Acute myocardial infarction
• Anaphylaxis
• Angioedema
• Arthritis
• Bacterial sepsis
• Bradycardia
• Bronchospastic pulmonary disease
• Chronic heart failure
• Dyspnea
• Hypersensitivity drug reaction
• Seizure disorder
• Shock
• Skin rash
• Syncope
• Unconsciousness

More Frequent

• Cramps
• Diarrhea
• Headache disorder
• Nausea
• Vomiting

Less Frequent

• Acute abdominal pain
• Arthralgia
• Back pain
• Conjunctivitis
• Cough
• Dizziness
• Dysgeusia
• Earache
• Fever
• General weakness
• Injection site sequelae
• Myalgia
• Pain in extremities

Rare or Very Rare

• Acute cognitive impairment
• Hyperhidrosis
• Pruritus of skin
• Urine discoloration

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Efficacy and safety of iron sucrose for iron maintenance therapy have been established in children 2 years of age or older with dialysis-dependent or non dialysis-dependent-chronic kidney disease. In a 12-week open-label, dose-ranging study in pediatric patients with chronic kidney disease (dialysis-dependent or non-dialysis dependent) who were receiving stable dosages of an erythropoiesis-stimulating agent (ESA), treatment with iron sucrose maintained hemoglobin concentrations between 10.5 and 14 g/dL in approximately 45-59% of the patients receiving 0.5, 1, or 2 mg/kg of the drug; a dose-response relationship was not demonstrated. Safety and efficacy of iron sucrose for iron replacement therapy in pediatric patients with chronic kidney disease have not been established.

Experience principally in another country revealed that 5 premature neonates (each weighing less than 1250 g) who received iron sucrose developed necrotizing enterocolitis; 2 of the 5 infants died during or following a period during which they received epoetin alfa, iron sucrose, and several other drugs concomitantly. A causal relationship to iron sucrose or any of the drugs could not be established.

Category B. (See Users Guide.)

It is not known whether iron sucrose is distributed into milk. Caution is advised if the drug is administered in nursing women.

Experience in those 65 years of age and older insufficient to determine whether they respond differently from younger adults; use caution in selecting and adjusting dosage. (See Dosage and Administration: Special Populations.)