IRON SUCROSE

In healthy adults administered intravenous doses of iron sucrose, its iron component exhibited first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, and steady state apparent volume of distribution of 7.9 L. The iron component appeared to distribute mainly in blood and to some extent in extravascular fluid. A study evaluating iron sucrose containing 100 mg of iron labeled with 52 Fe/ 59 Fe in patients with iron deficiency showed that a significant amount of the a...

14.1 Clinical Studies Overview Five clinical trials involving 647 adult patients and one clinical trial involving 131 pediatric patients were conducted to assess the safety and efficacy of iron sucrose. 14.2 Study A: Hemodialysis Dependent-Chronic Kidney Disease (HDD–CKD) Study A was a multicenter, open-label, historically-controlled study in 101 patients with HDD-CKD (77 patients with iron sucrose treatment and 24 in the historical control group) with IDA. Eligibility criteria for iron sucrose treatment included patients undergoing chronic hemodialysis, receiving erythropoietin, hemoglobin le...

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...

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

• 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. ( ...

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