IRON DEXTRAN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IRON DEXTRAN (IRON DEXTRAN).

How it works

Iron dextran is a colloidal solution of ferric oxyhydroxide complexed with dextran, which provides a source of iron for hemoglobin synthesis. After intramuscular or intravenous administration, the iron-dextran complex is taken up by the reticuloendothelial system, where iron is released and bound to transferrin for erythropoiesis.

What the body does with it

Metabolism	Iron dextran is metabolized by the reticuloendothelial system, where iron is released from the complex. The dextran component is degraded by dextranases and hepatic metabolism.
Excretion	Iron dextran is primarily excreted via the reticuloendothelial system; iron is incorporated into hemoglobin and stored as ferritin/ hemosiderin. Renal excretion of intact complexes is minimal (<1%). Fecal excretion accounts for less than 1% of the dose.
Half-life	The terminal elimination half-life is approximately 5-6 hours for the iron-dextran complex, but the iron released from the complex has a half-life of 2-3 days due to incorporation into erythrocytes and storage pools.
Protein binding	Iron is extensively bound to transferrin (approximately 95-100% binding capacity). The dextran component does not bind significantly to plasma proteins.
Volume of Distribution	The apparent volume of distribution is 0.7-1.3 L/kg, reflecting distribution into body tissues including bone marrow, liver, and spleen.
Bioavailability	Intravenous: 100%. Intramuscular: Approximately 50-60% absorbed within 72 hours; the remainder is absorbed over weeks from the injection site.
Onset of Action	Intravenous: Onset of hemoglobin rise is seen within 1-2 weeks; clinical improvement in anemia symptoms may be noted within days. Intramuscular: Similar onset but slower absorption.
Duration of Action	Duration of effect persists for weeks to months, depending on the degree of iron deficiency and ongoing losses. Reticulocyte response peaks at 7-10 days.

Classification & Brands

Dosing & administration

IM or IV: Calculate total iron deficit using formula: Body weight (kg) × (target Hb - actual Hb) × 0.24 + 500 mg (for iron stores). Administer as single IV infusion or daily IM doses up to 2 mL (100 mg) per day. IV infusion: Dilute in 0.9% NaCl and infuse over 1-6 hours; test dose of 25 mg recommended.

Dosage form	INJECTABLE
Renal impairment	No specific GFR-based dose adjustments are established; use with caution in patients with severe renal impairment (CrCl < 30 mL/min) due to potential iron overload and increased oxidative stress. Monitor iron parameters.
Liver impairment	No specific Child-Pugh based adjustments recommended; use with caution in severe hepatic impairment due to risk of iron overload and impaired clearance.
Pediatric use	IM: Not recommended for children under 4 months. IV: Calculate iron deficit: Body weight (kg) × (target Hb - actual Hb) × 0.24 + 500 mg for iron stores (for children ≥15 kg); for <15 kg, use 15 mg/kg for stores. Maximum single dose: 100 mg. Administer slowly.
Geriatric use	No specific dose adjustment; consider age-related renal function and comorbidities; start at lower end of dosing range; monitor for adverse reactions (e.g., anaphylaxis, iron overload).

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for IRON DEXTRAN (IRON DEXTRAN).

Breastfeeding	Iron dextran is excreted into breast milk in trace amounts. The M/P ratio is unknown. It is generally considered compatible with breastfeeding due to poor oral bioavailability for the infant; however, caution is advised in mothers with iron overload conditions.
Teratogenic Risk	Iron dextran is classified as FDA pregnancy risk category C. In the first trimester, there is limited human data; animal studies have shown no teratogenic effects at therapeutic doses. In the second and third trimesters, no increased risk of fetal anomalies has been reported, but iron overload may be harmful. Use only if clearly needed.

Warnings & precautions

■ FDA Black Box Warning

WARNING: ANAPHYLACTIC REACTIONS: Iron dextran can cause life-threatening anaphylactic reactions. Resuscitative equipment and personnel trained to treat anaphylaxis must be immediately available. Administer a test dose prior to the first therapeutic dose. Delay of 1 hour or more between test dose and therapeutic dose is recommended. Observe patient for at least 30 minutes after each injection.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of anaphylactic reaction to iron dextran","Hypersensitivity to dextran","Iron overload disorders (e.g., hemochromatosis, hemosiderosis)","Non-iron deficiency anemias (e.g., thalassemia, sideroblastic anemia)","Pregnancy (first trimester) unless clearly needed"]

Clinical Precautions

Precautions

["Risk of anaphylactic reactions; test dose required","Increased risk of hypersensitivity in patients with immune or inflammatory conditions","Iron overload risk with excessive dosing","Monitor serum ferritin and transferrin saturation","Use with caution in patients with liver disease","May exacerbate rheumatoid arthritis or other inflammatory conditions"]

Clinical Tips & Counseling

Drug interactions

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IRON DEXTRAN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IRON DEXTRAN (IRON DEXTRAN).

How it works

What the body does with it

Metabolism	Iron dextran is metabolized by the reticuloendothelial system, where iron is released from the complex. The dextran component is degraded by dextranases and hepatic metabolism.
Excretion	Iron dextran is primarily excreted via the reticuloendothelial system; iron is incorporated into hemoglobin and stored as ferritin/ hemosiderin. Renal excretion of intact complexes is minimal (<1%). Fecal excretion accounts for less than 1% of the dose.
Half-life	The terminal elimination half-life is approximately 5-6 hours for the iron-dextran complex, but the iron released from the complex has a half-life of 2-3 days due to incorporation into erythrocytes and storage pools.
Protein binding	Iron is extensively bound to transferrin (approximately 95-100% binding capacity). The dextran component does not bind significantly to plasma proteins.
Volume of Distribution	The apparent volume of distribution is 0.7-1.3 L/kg, reflecting distribution into body tissues including bone marrow, liver, and spleen.
Bioavailability	Intravenous: 100%. Intramuscular: Approximately 50-60% absorbed within 72 hours; the remainder is absorbed over weeks from the injection site.
Onset of Action	Intravenous: Onset of hemoglobin rise is seen within 1-2 weeks; clinical improvement in anemia symptoms may be noted within days. Intramuscular: Similar onset but slower absorption.
Duration of Action	Duration of effect persists for weeks to months, depending on the degree of iron deficiency and ongoing losses. Reticulocyte response peaks at 7-10 days.

Classification & Brands

Dosing & administration

Dosage form	INJECTABLE
Renal impairment	No specific GFR-based dose adjustments are established; use with caution in patients with severe renal impairment (CrCl < 30 mL/min) due to potential iron overload and increased oxidative stress. Monitor iron parameters.
Liver impairment	No specific Child-Pugh based adjustments recommended; use with caution in severe hepatic impairment due to risk of iron overload and impaired clearance.
Pediatric use	IM: Not recommended for children under 4 months. IV: Calculate iron deficit: Body weight (kg) × (target Hb - actual Hb) × 0.24 + 500 mg for iron stores (for children ≥15 kg); for <15 kg, use 15 mg/kg for stores. Maximum single dose: 100 mg. Administer slowly.
Geriatric use	No specific dose adjustment; consider age-related renal function and comorbidities; start at lower end of dosing range; monitor for adverse reactions (e.g., anaphylaxis, iron overload).

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for IRON DEXTRAN (IRON DEXTRAN).

Breastfeeding	Iron dextran is excreted into breast milk in trace amounts. The M/P ratio is unknown. It is generally considered compatible with breastfeeding due to poor oral bioavailability for the infant; however, caution is advised in mothers with iron overload conditions.
Teratogenic Risk	Iron dextran is classified as FDA pregnancy risk category C. In the first trimester, there is limited human data; animal studies have shown no teratogenic effects at therapeutic doses. In the second and third trimesters, no increased risk of fetal anomalies has been reported, but iron overload may be harmful. Use only if clearly needed.