SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

Multiple sequential single-dose intravenous pharmacokinetic studies were performed on 14 healthy iron-deficient volunteers. Entry criteria included hemoglobin ≥10.5 gm/dL and transferrin saturation ≤15% (TSAT) or serum ferritin value ≤20 ng/mL. In the first stage, each subject was randomized 1:1 to undiluted sodium ferric gluconate complex in sucrose injection of either 125 mg/hr or 62.5 mg/0.5 hr (2.1 mg/min). Five days after the first stage, each subject was re-randomized 1:1 to undiluted sodi...

Two clinical studies (Studies A and B) were conducted in adults and one clinical study was conducted in pediatric patients (Study C) to assess the efficacy and safety of sodium ferric gluconate complex in sucrose injection. Study A Study A was a three-center, randomized, open-label study of the safety and efficacy of two doses of sodium ferric gluconate complex in sucrose injection administered intravenously to iron-deficient hemodialysis patients. The study included both a dose-response concurrent control and an historical control. Enrolled patients received a test dose of sodium ferric gluco...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ] Hypotension [see Warnings and Precautions ( 5.2 ) ] The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps, and pain. In patients 6 to 1...

Sodium ferric gluconate complex in sucrose injection is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 ) ]. Known hypersensitivity to sodium ferric gluconate or any of its inactive components. ( 4 )

Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after sodium ferric gluconate complex in sucrose injection administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer sodium ferric gluconate complex in sucrose injection when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. ( 5.1 ) Hypotension: Sodium ferric glucona...

7 DRUG INTERACTIONS Drug-drug interactions involving sodium ferric gluconate complex in sucrose injection have not been studied. Sodium ferric gluconate complex in sucrose injection may reduce the absorption of concomitantly administered oral iron preparations.