PROFERDEX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PROFERDEX (PROFERDEX).

How it works

PROFERDEX (iron dextran) is a colloidal solution of ferric hydroxide in complex with dextran, providing a source of iron for hemoglobin synthesis and erythropoiesis. Iron is incorporated into heme, which is essential for oxygen transport in red blood cells.

What the body does with it

Metabolism	Iron dextran is metabolized by the reticuloendothelial system, and iron is released into the plasma where it binds to transferrin. Dextran is degraded by dextranase enzymes and excreted renally.
Excretion	Primarily fecal (biliary excretion of iron from degraded RBCs, about 80-90%); renal excretion negligible (<5% unchanged).
Half-life	Terminal half-life approximately 20-30 hours in patients with normal hepatic function; prolonged in hepatic impairment. Clinical context: supports every-3-week dosing.
Protein binding	Highly bound to transferrin (>99%) and ferritin; negligible free iron in circulation.
Volume of Distribution	Vd approximately 0.2-0.3 L/kg, reflecting distribution primarily into plasma and extracellular fluid; iron is rapidly taken up by reticuloendothelial system.
Bioavailability	Intravenous: 100%; intramuscular: variable, approximately 60-80% due to incomplete absorption and local precipitation.
Onset of Action	Intravenous: hemoglobin rise detectable within 1 week; iron utilization begins within 48 hours. Intramuscular: onset slower, typically 1-2 weeks due to absorption delay.
Duration of Action	Hemoglobin response sustained for 2-3 weeks after single dose; iron stores replenished for up to 4-6 weeks depending on deficiency severity.

Classification & Brands

Dosing & administration

100 mg intramuscular or intravenous every 3 to 7 days; may increase to 200 mg per dose.

Dosage form	INJECTABLE
Renal impairment	eGFR 30-89 mL/min: no adjustment; eGFR 15-29 mL/min: reduce dose by 50%; eGFR <15 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated.
Pediatric use	2 mg/kg intramuscular or intravenous every 3 to 7 days; maximum 100 mg per dose.
Geriatric use	Start at 50 mg per dose; titrate based on response; monitor renal function closely.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for PROFERDEX (PROFERDEX).

Breastfeeding	Not known if excreted in human milk. Caution advised. M/P ratio: not established. Consider developmental and health benefits of breastfeeding along with mother's clinical need.
Teratogenic Risk	No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Risk cannot be ruled out. First trimester: human data insufficient; second and third trimesters: risks unknown. Use only if potential benefit justifies potential risk to fetus.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

WARNING: ANaphylactic-type reactions, including fatalities, have occurred following parenteral iron dextran administration. A test dose should be administered prior to the first therapeutic dose. Resuscitation equipment and personnel trained to treat anaphylaxis must be immediately available.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to iron dextran or any component","All anemias not associated with iron deficiency (e.g., hemolytic anemia)","Iron overload syndromes (e.g., hemochromatosis, hemosiderosis)","Concurrent parenteral iron therapy with other iron formulations","History of significant allergic reactions to any parenteral iron product"]

Clinical Precautions

Precautions

["Risk of anaphylactic reactions (require test dose)","Hypersensitivity reactions including delayed reactions (arthralgia, myalgia, fever)","Iron overload (hemosiderosis) with excessive dosing","Increased risk of adverse reactions in patients with autoimmune diseases (e.g., rheumatoid arthritis)","Use caution in patients with hepatic impairment or acute infection"]

Clinical Tips & Counseling

Drug interactions

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PROFERDEX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PROFERDEX (PROFERDEX).

How it works

What the body does with it

Metabolism	Iron dextran is metabolized by the reticuloendothelial system, and iron is released into the plasma where it binds to transferrin. Dextran is degraded by dextranase enzymes and excreted renally.
Excretion	Primarily fecal (biliary excretion of iron from degraded RBCs, about 80-90%); renal excretion negligible (<5% unchanged).
Half-life	Terminal half-life approximately 20-30 hours in patients with normal hepatic function; prolonged in hepatic impairment. Clinical context: supports every-3-week dosing.
Protein binding	Highly bound to transferrin (>99%) and ferritin; negligible free iron in circulation.
Volume of Distribution	Vd approximately 0.2-0.3 L/kg, reflecting distribution primarily into plasma and extracellular fluid; iron is rapidly taken up by reticuloendothelial system.
Bioavailability	Intravenous: 100%; intramuscular: variable, approximately 60-80% due to incomplete absorption and local precipitation.
Onset of Action	Intravenous: hemoglobin rise detectable within 1 week; iron utilization begins within 48 hours. Intramuscular: onset slower, typically 1-2 weeks due to absorption delay.
Duration of Action	Hemoglobin response sustained for 2-3 weeks after single dose; iron stores replenished for up to 4-6 weeks depending on deficiency severity.

Classification & Brands

Dosing & administration

100 mg intramuscular or intravenous every 3 to 7 days; may increase to 200 mg per dose.

Dosage form	INJECTABLE
Renal impairment	eGFR 30-89 mL/min: no adjustment; eGFR 15-29 mL/min: reduce dose by 50%; eGFR <15 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated.
Pediatric use	2 mg/kg intramuscular or intravenous every 3 to 7 days; maximum 100 mg per dose.
Geriatric use	Start at 50 mg per dose; titrate based on response; monitor renal function closely.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for PROFERDEX (PROFERDEX).

Breastfeeding	Not known if excreted in human milk. Caution advised. M/P ratio: not established. Consider developmental and health benefits of breastfeeding along with mother's clinical need.
Teratogenic Risk	No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Risk cannot be ruled out. First trimester: human data insufficient; second and third trimesters: risks unknown. Use only if potential benefit justifies potential risk to fetus.
Fetal Monitoring