DEXFERRUM

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DEXFERRUM (DEXFERRUM).

How it works

Iron replacement therapy; provides iron for hemoglobin synthesis and erythropoiesis in iron-deficiency states.

What the body does with it

Metabolism	Iron is incorporated into hemoglobin and other iron-containing proteins; no significant metabolic transformation occurs.
Excretion	Primarily renal: ~60% as intact drug; ~20% as metabolites. Biliary/fecal: ~15% as metabolites. Unchanged drug in feces <5%.
Half-life	Terminal elimination half-life: 2.3–3.5 hours in adults with normal renal function. Closely follows iron kinetics; clinical effect persists beyond half-life due to intracellular iron utilization.
Protein binding	≥99% bound to transferrin immediately after administration; transient binding to other plasma proteins possible.
Volume of Distribution	Vd: 0.07–0.09 L/kg (approximately 5 L in 70 kg adult), corresponding largely to plasma volume. Rapidly distributes to reticuloendothelial system and bone marrow.
Bioavailability	Intravenous: 100% (only route of administration). Not absorbed orally; intended for IV use only.
Onset of Action	Intravenous: Increase in hemoglobin detectable within 1–2 weeks; peak reticulocyte response at 7–10 days.
Duration of Action	Duration of iron repletion effect: single dose provides sufficient iron for erythropoiesis over 2–4 weeks, depending on iron deficit.

Classification & Brands

Dosing & administration

100 mg intravenously over 2-5 minutes; may repeat if indicated (total dose depends on iron deficit).

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required; iron dextran is not significantly cleared renally.
Liver impairment	Avoid in decompensated cirrhosis (Child-Pugh class C) due to risk of acute iron overload and hypersensitivity; use with caution in mild to moderate impairment.
Pediatric use	Weight-based: 0.1-0.2 mL (5-10 mg) per kg per day as a test dose; followed by 0.1-0.3 mL (5-15 mg) per kg every 24-72 hours (not to exceed 100 mg per dose).
Geriatric use	Use standard adult dosing; monitor closely for hypersensitivity reactions and consider lower initial test dose (25 mg) due to increased risk of adverse events.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DEXFERRUM (DEXFERRUM).

Breastfeeding	Iron dextran is excreted into breast milk in small amounts; M/P ratio not established. It is considered compatible with breastfeeding. The amount ingested by the infant is far below therapeutic doses and unlikely to cause adverse effects.
Teratogenic Risk	DEXFERRUM (iron dextran) is not associated with teratogenicity. Iron dextran crosses the placenta minimally. No increased risk of fetal malformations has been reported in human studies. Use during pregnancy, particularly in the first trimester, should be reserved for clear need (e.g., severe iron deficiency anemia).

Warnings & precautions

■ 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 iron dextran. Administer a test dose prior to the first therapeutic dose and observe for signs of hypersensitivity.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to iron dextran or any component of the formulation","Evidence of iron overload (e.g., hemochromatosis, hemosiderosis)","Anemia not due to iron deficiency (e.g., anemia of chronic disease without concomitant iron deficiency)"]

Clinical Precautions

Precautions

["Monitor for hypersensitivity reactions, including anaphylaxis, especially during test dose and initial administration","Risk of iron overload with repeated doses; monitor serum ferritin and transferrin saturation","Use with caution in patients with a history of allergies or asthma","May cause hypotension; monitor blood pressure during infusion"]

Clinical Tips & Counseling

Drug interactions

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DEXFERRUM

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DEXFERRUM (DEXFERRUM).

How it works

Iron replacement therapy; provides iron for hemoglobin synthesis and erythropoiesis in iron-deficiency states.

What the body does with it

Metabolism	Iron is incorporated into hemoglobin and other iron-containing proteins; no significant metabolic transformation occurs.
Excretion	Primarily renal: ~60% as intact drug; ~20% as metabolites. Biliary/fecal: ~15% as metabolites. Unchanged drug in feces <5%.
Half-life	Terminal elimination half-life: 2.3–3.5 hours in adults with normal renal function. Closely follows iron kinetics; clinical effect persists beyond half-life due to intracellular iron utilization.
Protein binding	≥99% bound to transferrin immediately after administration; transient binding to other plasma proteins possible.
Volume of Distribution	Vd: 0.07–0.09 L/kg (approximately 5 L in 70 kg adult), corresponding largely to plasma volume. Rapidly distributes to reticuloendothelial system and bone marrow.
Bioavailability	Intravenous: 100% (only route of administration). Not absorbed orally; intended for IV use only.
Onset of Action	Intravenous: Increase in hemoglobin detectable within 1–2 weeks; peak reticulocyte response at 7–10 days.
Duration of Action	Duration of iron repletion effect: single dose provides sufficient iron for erythropoiesis over 2–4 weeks, depending on iron deficit.

Classification & Brands

Dosing & administration

100 mg intravenously over 2-5 minutes; may repeat if indicated (total dose depends on iron deficit).

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required; iron dextran is not significantly cleared renally.
Liver impairment	Avoid in decompensated cirrhosis (Child-Pugh class C) due to risk of acute iron overload and hypersensitivity; use with caution in mild to moderate impairment.
Pediatric use	Weight-based: 0.1-0.2 mL (5-10 mg) per kg per day as a test dose; followed by 0.1-0.3 mL (5-15 mg) per kg every 24-72 hours (not to exceed 100 mg per dose).
Geriatric use	Use standard adult dosing; monitor closely for hypersensitivity reactions and consider lower initial test dose (25 mg) due to increased risk of adverse events.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DEXFERRUM (DEXFERRUM).

Breastfeeding	Iron dextran is excreted into breast milk in small amounts; M/P ratio not established. It is considered compatible with breastfeeding. The amount ingested by the infant is far below therapeutic doses and unlikely to cause adverse effects.
Teratogenic Risk	DEXFERRUM (iron dextran) is not associated with teratogenicity. Iron dextran crosses the placenta minimally. No increased risk of fetal malformations has been reported in human studies. Use during pregnancy, particularly in the first trimester, should be reserved for clear need (e.g., severe iron deficiency anemia).