IV iron preparations approved by the US Food and Drug Administration
| . | Brand name . | FDA-approved indication . | Boxed warning . | Carbohydrate shell . | Dosage forms and strengths . | FDA-approved iron dose . | FDA-approved administration rate . |
|---|---|---|---|---|---|---|---|
| Low molecular weight iron dextran | INFeD | “...treatment of adult and pediatric patients of age 4 mo and older with documented iron deficiency who have intolerance to oral iron or an unsatisfactory response to oral iron.” | Yes | Dextran polysaccharide | Injection: 100 mg/2 mL (50 mg/mL) in single-dose vials | IV test dose, 0.5 mL. Treatment: daily doses ≤ 2 mL until total dose given | 50 mg/min |
| Ferumoxytol | Feraheme | “...treatment of IDA in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have CKD.” | Yes | Polyglucose sorbitol carboxymethylether | Injection: 510 mg iron per 17 mL (30 mg per mL) in single-dose vial. | Initial: 510 mg Second: 510 mg, 3-8 days later | 510 mg/15 min |
| Ferric carboxymaltose | Injectafer | “... treatment of IDA in adults and pediatric patients 1 y of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron; adult patients who have nondialysis dependent CKD.” | No | Carboxymaltose | Injection: 50 mg/mL: 100 mg iron/2 mL in single-dose vials; 750 mg iron/15 mL single-dose vials; 1000 mg iron/20 mL single-dose vials | 750 mg IV in 2 doses separated by at least 7 days for total dose of 1500 mg, or 15 mg/kg to ≤1000 mg as a single dose | 100 mg/min |
| Ferric derisomaltose | Monoferric | “...the treatment of IDA in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron, or • who have nonhemodialysis dependent CKD.” | No | Derisomaltose | Injection: 1000 mg iron/10 mL (100 mg/mL); 500 mg iron/5 mL (100 mg/mL); 100 mg iron/mL in single-dose vials | 1000 mg IV | 1000 mg/20 min |
| Iron sucrose | Venofer | “...the treatment of IDA in patients with CKD.” | No | Sucrose | Injection: 50 mg/2.5 mL, 100 mg/5 mL, or 200 mg/10 mL (20 mg/mL) in single-dose vials | Hemodialysis: 100 mg slow IV Nondialysis CKD: 200 mg slow IV Peritoneal dialysis CKD: 300-400 IV | 100 mg/2 to 5 min |
| Ferric gluconate | Ferrlecit | “...treatment of IDA in adult patients and in pediatric patients age 6 y and older with CKD receiving hemodialysis who are receiving supplemental epoetin therapy.” | No | Gluconate | Injection: 62.5 mg/5 mL (12.5 mg/mL) in single-dose vial. | Per dialysis session: 125 mg diluted in 100 mL 0.9% saline over 1 h, or as slow IV infusion, ≤12.5 mg/min | 12.5 mg/min |
| . | Brand name . | FDA-approved indication . | Boxed warning . | Carbohydrate shell . | Dosage forms and strengths . | FDA-approved iron dose . | FDA-approved administration rate . |
|---|---|---|---|---|---|---|---|
| Low molecular weight iron dextran | INFeD | “...treatment of adult and pediatric patients of age 4 mo and older with documented iron deficiency who have intolerance to oral iron or an unsatisfactory response to oral iron.” | Yes | Dextran polysaccharide | Injection: 100 mg/2 mL (50 mg/mL) in single-dose vials | IV test dose, 0.5 mL. Treatment: daily doses ≤ 2 mL until total dose given | 50 mg/min |
| Ferumoxytol | Feraheme | “...treatment of IDA in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have CKD.” | Yes | Polyglucose sorbitol carboxymethylether | Injection: 510 mg iron per 17 mL (30 mg per mL) in single-dose vial. | Initial: 510 mg Second: 510 mg, 3-8 days later | 510 mg/15 min |
| Ferric carboxymaltose | Injectafer | “... treatment of IDA in adults and pediatric patients 1 y of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron; adult patients who have nondialysis dependent CKD.” | No | Carboxymaltose | Injection: 50 mg/mL: 100 mg iron/2 mL in single-dose vials; 750 mg iron/15 mL single-dose vials; 1000 mg iron/20 mL single-dose vials | 750 mg IV in 2 doses separated by at least 7 days for total dose of 1500 mg, or 15 mg/kg to ≤1000 mg as a single dose | 100 mg/min |
| Ferric derisomaltose | Monoferric | “...the treatment of IDA in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron, or • who have nonhemodialysis dependent CKD.” | No | Derisomaltose | Injection: 1000 mg iron/10 mL (100 mg/mL); 500 mg iron/5 mL (100 mg/mL); 100 mg iron/mL in single-dose vials | 1000 mg IV | 1000 mg/20 min |
| Iron sucrose | Venofer | “...the treatment of IDA in patients with CKD.” | No | Sucrose | Injection: 50 mg/2.5 mL, 100 mg/5 mL, or 200 mg/10 mL (20 mg/mL) in single-dose vials | Hemodialysis: 100 mg slow IV Nondialysis CKD: 200 mg slow IV Peritoneal dialysis CKD: 300-400 IV | 100 mg/2 to 5 min |
| Ferric gluconate | Ferrlecit | “...treatment of IDA in adult patients and in pediatric patients age 6 y and older with CKD receiving hemodialysis who are receiving supplemental epoetin therapy.” | No | Gluconate | Injection: 62.5 mg/5 mL (12.5 mg/mL) in single-dose vial. | Per dialysis session: 125 mg diluted in 100 mL 0.9% saline over 1 h, or as slow IV infusion, ≤12.5 mg/min | 12.5 mg/min |
Summary only; refer to full prescribing information and patient information for these IV iron preparations at Drugs@FDA (https://www.accessdata.fda.gov/scripts/cder/daf/). Boxed warnings: INFeD: “warning: risk for anaphylactic-type reactions. Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection” (refer to full prescribing information for complete boxed warning). Feraheme: “warning: risk for serious hypersensitivity/anaphylaxis reactions see full prescribing information for complete boxed warning.”
CKD, chronic kidney disease; IDA, iron deficiency anemia.