FERRLECIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FERRLECIT (FERRLECIT).
Ferric carboxymaltose, a polynuclear iron(III)-hydroxide carbohydrate complex, provides a source of iron for hemoglobin synthesis and erythropoiesis. The iron is released to endogenous iron transport proteins, such as transferrin, and stored as ferritin or hemosiderin.
| Metabolism | Ferric carboxymaltose is taken up by the reticuloendothelial system where iron is released and incorporated into iron stores. Iron elimination is minimal; iron is primarily recycled by the body. |
| Excretion | Iron is not excreted renally; elimination is primarily through fecal loss of unabsorbed iron (approximately 80-90% of orally administered iron) and minor desquamation of mucosal cells. After IV administration, iron is incorporated into hemoglobin and storage pools; minimal urinary excretion (<1%). Biliary excretion of iron is negligible. |
| Half-life | Sodium ferric gluconate has a terminal half-life of approximately 1 hour for the intact complex. However, after dissociation, iron is rapidly cleared from plasma with a half-life of about 6 hours. The clinical context: the short half-life minimizes free iron toxicity but requires frequent dosing for iron replacement. |
| Protein binding | 99% bound to transferrin and ferritin; may also bind to albumin. |
| Volume of Distribution | Vd for the iron complex is approximately 0.4 L/kg (central compartment). Iron is distributed to bone marrow, liver, spleen, and erythroid precursor cells. The large Vd reflects extensive tissue uptake. |
| Bioavailability | Only IV administration; oral bioavailability is not applicable as it is not given orally. If referring to iron absorption from the complex in other contexts, it is not applicable. |
| Onset of Action | IV administration: Increase in reticulocyte count occurs within 3-7 days; hemoglobin rise begins after 1-2 weeks. |
| Duration of Action | A single IV dose of FERRLECIT provides enough iron for erythropoiesis for approximately 2-3 weeks, depending on the degree of iron deficiency and concurrent erythropoietin therapy. |
125 mg elemental iron (5 mL) intravenously over 1-5 minutes or as infusion over 15-30 minutes, repeated as needed based on iron deficiency.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required; monitor iron status in patients with end-stage renal disease on dialysis. |
| Liver impairment | Contraindicated in decompensated cirrhosis (Child-Pugh C); use with caution in Child-Pugh A and B with monitoring. |
| Pediatric use | Not established for children under 6 years; for older children, 1.5 mg/kg elemental iron IV up to 125 mg/dose, infused over 1-5 minutes or as directed. |
| Geriatric use | No specific dose adjustment; monitor for hypotension and infusion reactions due to age-related comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FERRLECIT (FERRLECIT).
| Breastfeeding | It is not known whether this drug is excreted in human milk. Caution should be exercised when administered to a nursing woman. M/P ratio: Not established. |
| Teratogenic Risk | FERRLECIT (sodium ferric gluconate complex) is classified as FDA Pregnancy Category C. Animal studies have not been conducted; it is not known whether ferric gluconate can cause fetal harm when administered to a pregnant woman. Use only if clearly needed. There are no adequate and well-controlled studies in pregnant women. Risk cannot be ruled out across all trimesters. |
■ FDA Black Box Warning
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving FERRLECIT. Monitor patients for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable. FERRLECIT is contraindicated in patients with a history of hypersensitivity to any component of FERRLECIT.
| Serious Effects |
["History of hypersensitivity to FERRLECIT or any of its components","Evidence of iron overload","Anemia not caused by iron deficiency"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Hypertension: Monitor blood pressure; transient hypertension may occur","Laboratory test alterations: May falsely elevate serum iron and transferrin saturation for up to 24 hours after dosing","Iron overload: Risk in patients with iron overload disorders"] |
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| Fetal Monitoring |
| Monitor for signs of hypersensitivity, hypotension, and iron overload. Periodic monitoring of hematocrit, hemoglobin, serum ferritin, transferrin saturation, and iron levels is recommended. Fetal monitoring as per standard obstetric care; no specific fetal monitoring required. |
| Fertility Effects | No studies on fertility have been conducted. It is not known whether ferric gluconate affects fertility in humans. |