SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE).
Sodium ferric gluconate complex in sucrose provides elemental iron for hemoglobin synthesis and replenishes iron stores in iron-deficient states. The iron complex is taken up by the reticuloendothelial system, where iron is released and bound to transferrin for erythropoiesis.
| Metabolism | Iron is bound to ferritin and hemosiderin; excreted via feces, urine, and bile; no significant hepatic metabolism. |
| Excretion | Primarily excreted via feces (93%) as non-absorbed iron; renal elimination of absorbed iron is minimal (<1%). |
| Half-life | Terminal elimination half-life is approximately 6 hours for the iron-sucrose complex; clinical context: indicates redistribution and utilization for erythropoiesis, with full hemoglobin correction over weeks. |
| Protein binding | Approximately 99% bound to transferrin and other serum proteins (mainly iron-binding proteins). |
| Volume of Distribution | Vd approximately 0.14 L/kg for the iron component; indicates limited distribution into extravascular space, primarily confined to plasma and erythroid marrow. |
| Bioavailability | Intravenous: 100% (not absorbed orally; oral bioavailability is negligible and not a route for iron replacement therapy). |
| Onset of Action | Intravenous: reticulocyte response within 3–7 days; hemoglobin rise begins after 1–2 weeks. |
| Duration of Action | Single dose provides iron for erythropoiesis over several weeks; clinical effect sustained until iron stores are depleted (typically 2–4 weeks per dose). |
125 mg elemental iron (10 mL) intravenously over at least 10 minutes, given at sequential dialysis sessions to a cumulative total dose of 1000 mg elemental iron.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment as it is not renally eliminated; use with caution in patients with GFR <30 mL/min due to potential accumulation of sucrose. |
| Liver impairment | No specific guidelines; use with caution in severe hepatic impairment (Child-Pugh class C) due to limited data. |
| Pediatric use | Safety and efficacy not established in pediatric patients; not recommended. |
| Geriatric use | No specific dose adjustment; consider age-related comorbidities and concurrent medications; monitor for adverse reactions as elderly may be more susceptible to iron overload and hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE).
| Breastfeeding | Small amounts of iron are excreted in breast milk. The M/P ratio is not established. Use with caution in nursing mothers; consider the benefits of breastfeeding and the importance of the drug to the mother. No known adverse effects on the infant from therapeutic doses. |
| Teratogenic Risk | Animal reproduction studies have not been conducted with sodium ferric gluconate complex. It is not known whether it can cause fetal harm when administered to a pregnant woman. Iron deficiency anemia in pregnancy is associated with maternal and fetal risks, and treatment with intravenous iron may be necessary. Use only if clearly needed. First trimester risks are theoretical; second and third trimesters generally considered safe with caution. |
■ FDA Black Box Warning
Fatal hypersensitivity reactions including anaphylaxis have occurred in patients receiving sodium ferric gluconate complex in sucrose. Emergency resuscitation equipment and personnel trained to treat such reactions must be immediately available during administration.
| Serious Effects |
["Hypersensitivity to sodium ferric gluconate complex in sucrose or any component of the formulation","Evidence of iron overload (e.g., serum ferritin > 800 ng/mL or transferrin saturation > 50%)","Anemia not caused by iron deficiency"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Iron overload","Hypotension","Risk of infection from multiple-dose vials (contains benzyl alcohol not for use in neonates)"] |
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| Fetal Monitoring | Monitor hemoglobin, hematocrit, serum ferritin, and iron studies regularly. Blood pressure and heart rate monitoring during infusion due to risk of hypotension. Observe for signs of hypersensitivity or anaphylaxis during and after administration. Fetal heart rate monitoring if indicated by maternal condition. |
| Fertility Effects | No known adverse effects on fertility. Iron deficiency may impair fertility; correction of iron deficiency may improve fertility. |