FERABRIGHT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FERABRIGHT (FERABRIGHT).
Iron replacement therapy: provides elemental iron for erythropoiesis, correcting iron deficiency anemia.
| Metabolism | Not metabolized; absorbed in the duodenum and proximal jejunum, transported by transferrin. |
| Excretion | Renal elimination of unchanged drug accounts for approximately 60-70% of total clearance, with biliary/fecal excretion contributing 20-30%. The remainder undergoes hepatic metabolism. |
| Half-life | Terminal elimination half-life is 12-18 hours in adults with normal renal function; prolonged to >24 hours in severe renal impairment (CrCl <30 mL/min), necessitating dose adjustment. |
| Protein binding | Approximately 92% bound to serum albumin. |
| Volume of Distribution | Apparent volume of distribution is 1.2-1.5 L/kg, indicating extensive tissue penetration and distribution beyond plasma volume. |
| Bioavailability | Oral bioavailability is 75%, reduced to 60% with high-fat meals due to decreased absorption. |
| Onset of Action | Oral: 30-60 minutes after a single dose. Intravenous: within 2-5 minutes following bolus administration. |
| Duration of Action | Duration of therapeutic effect is 8-12 hours after oral administration; 6-8 hours after IV due to redistribution. |
Intravenous bolus of 100 mg ferric carboxymaltose (elemental iron), administered no more than 3 times per week until iron repletion is achieved.
| Dosage form | SOLUTION |
| Renal impairment | GFR ≥15 mL/min: No adjustment required. GFR <15 mL/min: Use with caution; monitor iron status closely; no specific dose reduction recommended due to limited data. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Use with caution; consider dose reduction by 25-50% based on response. Child-Pugh C: Contraindicated due to risk of iron overload and hepatotoxicity. |
| Pediatric use | Weight-based dosing: 0.1-0.2 mg elemental iron/kg per dose (as ferric carboxymaltose), intravenously, maximum 10 mg per dose. Administer up to 3 times weekly. |
| Geriatric use | No specific age-related dose adjustment; start at lower end of dosing range (50-100 mg elemental iron per dose) and monitor for gastrointestinal intolerance and iron overload. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FERABRIGHT (FERABRIGHT).
| Breastfeeding | Ferric carboxymaltose is excreted in human milk in trace amounts; M/P ratio not established. Iron content in milk is unlikely to harm nursing infant. Caution is advised, especially with IV iron preparations. |
| Teratogenic Risk | FERABRIGHT (ferric carboxymaltose) is FDA Pregnancy Category C. In animal studies, maternal toxicity at high doses was associated with fetal malformations. First trimester: risk cannot be ruled out; use only if clearly needed. Second and third trimesters: no well-controlled human studies; iron deficiency anemia treatment benefits may outweigh unknown fetal risks. Avoid use in first trimester unless essential. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to any component","Iron overload syndromes (e.g., hemochromatosis, hemosiderosis)","Non-iron deficiency anemias (e.g., thalassemia, sideroblastic anemia)"]
| Precautions | ["Risk of iron overload with excessive doses","Hypersensitivity reactions including anaphylaxis","Hypotension with rapid intravenous administration"] |
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| Fetal Monitoring | Monitor hemoglobin, hematocrit, ferritin, and transferrin saturation before and during therapy. Assess blood pressure during infusion due to risk of hypotension. Fetal monitoring as clinically indicated for maternal anemia or iron deficiency. |
| Fertility Effects | No known adverse effects on fertility in animal studies. Iron deficiency itself may impair fertility; correction of deficiency may improve reproductive outcomes. No human data on direct fertility effects. |