FERRLECIT (sodium ferric gluconate complex)

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 Ferrlecit 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 Ferrlecit injection of either 125 mg/...

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 Ferrlecit. Study A Study A was a three-center, randomized, open-label study of the safety and efficacy of two doses of Ferrlecit 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 Ferrlecit (25 mg of elemental iron) and were then randomly assigned to receive Ferrlecit at cumulative do...

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 15 year...

Ferrlecit 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 Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. ( 5.1 ) Hypotension: Ferrlecit may cause hypotension. Monitor patients for signs and symptoms of hypotension during and followin...

7 DRUG INTERACTIONS Drug-drug interactions involving Ferrlecit have not been studied. Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations.