MONOFERRIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MONOFERRIC (MONOFERRIC).
Monomeric ferric iron replaces iron stores and is incorporated into hemoglobin, myoglobin, and enzymes, supporting erythropoiesis and oxygen transport.
| Metabolism | Iron is absorbed and transported via transferrin; stored as ferritin and hemosiderin; not metabolized by CYP enzymes. |
| Excretion | Renal: <1% unchanged; Biliary/fecal: >99% as iron in RBC turnover and storage |
| Half-life | Terminal half-life: 10-14 hours for ferric carboxymaltose core; clinical effect persists for weeks due to iron utilization |
| Protein binding | Ferric iron: 99.9% bound to transferrin and ferritin |
| Volume of Distribution | Vd: 3-4 L (approximates plasma volume); iron is rapidly distributed to reticuloendothelial system and bone marrow |
| Bioavailability | IV: 100% (only route); oral: not applicable (no oral formulation) |
| Onset of Action | IV: Increase in hemoglobin detectable within 1-2 weeks; reticulocyte response within 3-5 days |
| Duration of Action | Single IV dose provides iron stores for 2-4 weeks; hemoglobin normalization typically within 4-6 weeks |
100-200 mg elemental iron intravenously as a single dose, repeated weekly until iron stores are replete. Typical total dose is 1-2 g.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, use with caution; consider lower dose or prolonged infusion interval. |
| Liver impairment | Contraindicated in Child-Pugh class C. In Child-Pugh class A or B, no specific dose adjustment established; use with caution. |
| Pediatric use | Children ≥2 years: 0.15 mg/kg elemental iron intravenously once weekly, up to a maximum of 100 mg per dose. No established dosing for infants <2 years. |
| Geriatric use | Standard dosing applies; monitor for signs of iron overload and cardiovascular function due to potential for hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MONOFERRIC (MONOFERRIC).
| Breastfeeding | Iron is excreted in breast milk; M/P ratio not established. Therapeutic doses are considered safe. Monitor infant for gastrointestinal effects. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies. Inadequate human data for first trimester; iron is essential for fetal development but excess may be harmful. In second and third trimesters, therapeutic doses are considered safe; toxicity from overdose can cause fetal harm. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to iron products","Evidence of iron overload (e.g., hemochromatosis)","Anemia not caused by iron deficiency"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Iron overload with repeated administration","Hypotension with rapid IV infusion","Risks in patients with infections or inflammatory conditions"] |
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| Monitor hemoglobin, hematocrit, serum ferritin, and iron indices periodically. Assess for signs of iron overload. Fetal monitoring for growth and development if maternal anemia is severe. |
| Fertility Effects | No adverse effects on fertility reported. Iron deficiency may impair fertility; correction improves outcomes. |