The product, sodium ferric gluconate complex in sucrose, contains benzyl alcohol, therefore, it should not be used in neonates. The safety and efficacy of sodium ferric gluconate complex in pediatric patients has not been established. There were not sufficient numbers of geriatric patients enrolled in the trials to assess efficacy and safety in this patient population. A general recommendation is to start the doses low in the elderly and titrate to optimal iron supplementation levels in the patient. Sodium ferric gluconate complex is contraindicated in patients with non-iron deficiency anemia or hypersensitivity to the product or any of its inactive ingredients.
Hypersensitivity can lead to a potentially fatal reaction.
Rapid intravenous administration of iron has been associated with flushing, lightheadedness, malaise, weakness or pain in the chest, back, flanks and groin. These symptoms have been noted to typically resolve with one to two hours of administration. Sodium ferric gluconate complex has not been studied in an adequate and well-controlled fashion in pregnant women. It has a FDA Category B, but should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Caution should be used when sodium ferric gluconate complex is administered to a nursing woman, since it is not known whether this drug is excreted in human milk.