INFED

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INFED (INFED).

How it works

Iron dextran provides elemental iron, which is incorporated into hemoglobin and myoglobin, and serves as a cofactor in various enzymatic reactions. Iron is essential for erythropoiesis and oxygen transport.

What the body does with it

Metabolism	Iron dextran is a colloidal solution of iron carbohydrate complex. The iron moiety is primarily processed by the reticuloendothelial system, where iron is released and incorporated into ferritin and hemosiderin. Small amounts are excreted in urine, bile, and feces.
Excretion	Primarily excreted via feces as unabsorbed iron (approx. 60-70% of a parenteral dose is retained; the remainder is excreted slowly over weeks to months via bile and feces). Renal excretion of iron is negligible (<1%).
Half-life	Terminal elimination half-life: approximately 5-6 hours for free iron, but redistribution and incorporation into hemoglobin prolong functional half-life to days. Clinically, total body iron stores are replenished over weeks.
Protein binding	More than 90% bound to transferrin and ferritin in plasma; negligible binding to albumin.
Volume of Distribution	Apparent Vd: approximately 3-6 L/kg, indicating extensive distribution into tissues, particularly bone marrow, liver, and spleen.
Bioavailability	Intravenous: 100%; Intramuscular: Variable (10-50%) but unreliable; oral: Not applicable (INFED is parenteral).
Onset of Action	Intravenous: Hematologic response (reticulocytosis) within 3-5 days; hemoglobin rise begins within 1-2 weeks. Intramuscular: Onset delayed due to slower absorption.
Duration of Action	Duration of therapeutic effect: Hemoglobin correction over 2-4 weeks; iron stores replenished over 1-3 months. The drug itself is cleared rapidly but iron is retained.

Classification & Brands

Dosing & administration

50 mg elemental iron (as iron dextran) intravenously or intramuscularly, daily, until total iron deficiency is corrected. Total dose (mg) = 0.3 × weight (kg) × (desired Hb - actual Hb) + iron stores (500 mg if weight ≥ 50 kg, otherwise 15 mg/kg).

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment required for renal impairment; use with caution in patients with chronic kidney disease due to risk of iron overload. Monitor serum ferritin and transferrin saturation.
Liver impairment	Contraindicated in decompensated cirrhosis (Child-Pugh class C). For Child-Pugh A or B, use with caution and monitor liver function; dose reduction not specifically defined.
Pediatric use	Total dose (mg) = 0.3 × weight (kg) × (desired Hb - actual Hb) + iron stores (15 mg/kg for children <35 kg). Administer as IV infusion or IM injection; maximum daily dose: 1.5 mg/kg elemental iron. Not recommended for infants <4 months.
Geriatric use	Use standard dosing with caution; monitor for iron overload and adverse reactions. Consider reduced total dose based on lower body weight and comorbidities; assess renal and hepatic function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for INFED (INFED).

Breastfeeding	Iron dextran is excreted into breast milk in trace amounts; M/P ratio not established. The American Academy of Pediatrics considers it compatible with breastfeeding. However, caution due to potential for maternal anaphylaxis. Monitor infant for gastrointestinal disturbances.
Teratogenic Risk	FDA Pregnancy Category C. Iron dextran crosses the placenta. First trimester: Avoid use; animal studies show increased resorptions and fetal anomalies. Second and third trimesters: Use only if clearly needed; no well-controlled human studies; potential for anaphylactic reactions affecting uteroplacental perfusion.

Warnings & precautions

■ FDA Black Box Warning

Risk of anaphylactic-type reactions, including fatal anaphylaxis, especially in patients with a history of drug allergy or multiple drug allergies. Resuscitative equipment and personnel trained in anaphylaxis management must be immediately available during administration.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known 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., hemolytic anemia)"]

Clinical Precautions

Precautions

["Risk of anaphylactic reactions; administer a test dose before full dose","Monitor for hypersensitivity reactions during and after administration","Risk of iron overload with excessive use; monitor serum ferritin and transferrin saturation","Potential for delayed reactions (e.g., arthralgia, myalgia, fever) 24-48 hours after administration","Use with caution in patients with hepatic impairment, acute infection, or history of asthma or eczema"]

Clinical Tips & Counseling

Drug interactions

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INFED

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INFED (INFED).

How it works

What the body does with it

Metabolism	Iron dextran is a colloidal solution of iron carbohydrate complex. The iron moiety is primarily processed by the reticuloendothelial system, where iron is released and incorporated into ferritin and hemosiderin. Small amounts are excreted in urine, bile, and feces.
Excretion	Primarily excreted via feces as unabsorbed iron (approx. 60-70% of a parenteral dose is retained; the remainder is excreted slowly over weeks to months via bile and feces). Renal excretion of iron is negligible (<1%).
Half-life	Terminal elimination half-life: approximately 5-6 hours for free iron, but redistribution and incorporation into hemoglobin prolong functional half-life to days. Clinically, total body iron stores are replenished over weeks.
Protein binding	More than 90% bound to transferrin and ferritin in plasma; negligible binding to albumin.
Volume of Distribution	Apparent Vd: approximately 3-6 L/kg, indicating extensive distribution into tissues, particularly bone marrow, liver, and spleen.
Bioavailability	Intravenous: 100%; Intramuscular: Variable (10-50%) but unreliable; oral: Not applicable (INFED is parenteral).
Onset of Action	Intravenous: Hematologic response (reticulocytosis) within 3-5 days; hemoglobin rise begins within 1-2 weeks. Intramuscular: Onset delayed due to slower absorption.
Duration of Action	Duration of therapeutic effect: Hemoglobin correction over 2-4 weeks; iron stores replenished over 1-3 months. The drug itself is cleared rapidly but iron is retained.

Classification & Brands

Dosing & administration

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment required for renal impairment; use with caution in patients with chronic kidney disease due to risk of iron overload. Monitor serum ferritin and transferrin saturation.
Liver impairment	Contraindicated in decompensated cirrhosis (Child-Pugh class C). For Child-Pugh A or B, use with caution and monitor liver function; dose reduction not specifically defined.
Pediatric use	Total dose (mg) = 0.3 × weight (kg) × (desired Hb - actual Hb) + iron stores (15 mg/kg for children <35 kg). Administer as IV infusion or IM injection; maximum daily dose: 1.5 mg/kg elemental iron. Not recommended for infants <4 months.
Geriatric use	Use standard dosing with caution; monitor for iron overload and adverse reactions. Consider reduced total dose based on lower body weight and comorbidities; assess renal and hepatic function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for INFED (INFED).

Breastfeeding	Iron dextran is excreted into breast milk in trace amounts; M/P ratio not established. The American Academy of Pediatrics considers it compatible with breastfeeding. However, caution due to potential for maternal anaphylaxis. Monitor infant for gastrointestinal disturbances.
Teratogenic Risk	FDA Pregnancy Category C. Iron dextran crosses the placenta. First trimester: Avoid use; animal studies show increased resorptions and fetal anomalies. Second and third trimesters: Use only if clearly needed; no well-controlled human studies; potential for anaphylactic reactions affecting uteroplacental perfusion.