Iron Sucrose

Brand Names: Iron Sucrose

Drug Class: Parenteral Iron Replacement

Overview

11 DESCRIPTION Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous solution, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: where: n is the degree of iron polymerization and m is the number of sucrose molecules...

Mechanism of Action

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Iron sucrose is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, iron sucrose is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells. 12.2 Pharmacodynamics Following intravenous administration, iron sucrose is dissociated into iron and sucrose. In 22 patients undergoing hemodialysis and receiving erythropoietin (recombinant human erythropoietin) therapy treated with iron sucrose containing 100 mg of iron, three times weekly for three weeks, significant increases in serum iron and serum...

Indications

  • 1 INDICATIONS AND USAGE Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )

Common Doses

  • 100 mg
  • 200 mg
  • 300 mg
  • 400 mg

Dosage

2 DOSAGE AND ADMINISTRATION Population Dose Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) ( 2.2 ) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) ( 2.3 ) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) ( 2.4 ) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD ( 2.5 ), PDD-CKD or NDD-CKD ( 2.6 ) 0.5 mg/kg slow intravenous injection or infusion 2.

Contraindications

  • 4 CONTRAINDICATIONS • Known hypersensitivity to iron sucrose. • Known hypersensitivity to iron sucrose. ( 4 )

Side Effects

  • 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Hypotension [see Warnings and Precautions (5.2) ] • Iron Overload [see Warnings and Precautions (5.3) ] • Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.

Interactions

  • 7 DRUG INTERACTIONS Iron sucrose may reduce the absorption of concomitantly administered oral iron preparations.