Iron sucrose

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 )

• Population Dose Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) 300 mg or 400 mg intravenous infusion
• Pediatric patients HDD-CKD , PDD-CKD or NDD-CKD 0.5 mg/kg slow intravenous injection or infusion Mode of Administration Administer iron sucrose injection only intravenously by slow injection or by infusion
• The dosage of iron sucrose injection is expressed in mg of elemental iron
• Each mL contains 20 mg of elemental iron
• Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Administer iron sucrose injection 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session [see How Supplied/Storage and Handling ]
• Administer iron sucrose injection early during the dialysis session (generally within the first hour)
• The usual total treatment course of iron sucrose injection is 1000 mg
• Iron sucrose injection treatment may be repeated if iron deficiency reoccurs. …

Injection: 50 mg Elemental Iron/2.5 mL (20 mg/mL), 100 mg Elemental Iron/5 mL (20 mg/mL), or 200 mg Elemental Iron/10 mL (20 mg/mL) in single-dose vials. Injection: 50 mg Elemental Iron/2.5 mL (20 mg/mL), 100 mg Elemental Iron/5 mL (20 mg/mL), or 200 mg Elemental Iron/10 mL (20 mg/mL) in single-dose vials. ( 3 )

• Safety and effectiveness of iron sucrose for iron replacement treatment
• In pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established
• Safety and effectiveness of iron sucrose for iron maintenance treatment
• In pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied
• Iron sucrose at doses of 0.5 mg/kg, 1 mg/kg, and 2 mg/kg was administered. …

Of the 1,051 patients in two post-marketing safety studies of iron sucrose, 40% were 65 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. …

• Prior History of Reactions to Parenteral Iron Products Question patients regarding any prior history of reactions to parenteral iron products [see Warnings and Precautions ]
• Serious Hypersensitivity Reactions Advise patients to report any symptoms of hypersensitivity that may develop during and following iron sucrose administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see Warnings and Precautions ]
• Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India JUNE 2025 50105408

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

Iron sucrose may reduce the absorption of concomitantly administered oral iron preparations.

• Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after iron sucrose administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer iron sucrose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) • Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration. ( 5.2 ) • Iron Overload: Regularly monitor hematologic responses during therapy. Do not administer to patients with iron overload. …

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. …

8.1 Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes ( see Data ). Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. …

No data are available regarding overdosage of iron sucrose in humans. Excessive dosages of iron sucrose may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer iron sucrose to patients with iron overload [see Warnings and Precautions (5.3) ] . Iron sucrose is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. …

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