VENOFER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VENOFER (VENOFER).

How it works

Iron replacement therapy; iron is essential for hemoglobin synthesis and oxygen transport. VENOFER (iron sucrose) provides elemental iron that binds to transferrin for transport to erythroid precursor cells.

What the body does with it

Metabolism	Iron sucrose is dissociated into iron and sucrose by the reticuloendothelial system. Iron is incorporated into hemoglobin or stored as ferritin. Sucrose is excreted renally.
Excretion	Primarily reticuloendothelial system; iron is incorporated into hemoglobin and stored as ferritin/hemosiderin. Minimal renal excretion (<1% unchanged). Fecal elimination negligible. Small amounts lost via desquamation, blood loss, and menstruation.
Half-life	5-6 hours (initial phase, redistribution); terminal half-life ~14 hours (iron clearance from plasma). Clinical context: reflects iron utilization and storage, not elimination of drug.
Protein binding	Binds to transferrin for transport; after release, iron binds to ferritin and hemosiderin. Overall protein binding is >90% (mainly to transferrin).
Volume of Distribution	Vd approximately 3.0-3.4 L/kg in iron-deficiency anemia. Reflects extensive distribution into reticuloendothelial system and bone marrow.
Bioavailability	Intravenous only; oral bioavailability is 0% as sucrose formulation cannot be absorbed. Not administered via other routes.
Onset of Action	IV administration: Hemoglobin increase detectable within 1-2 weeks; reticulocyte response in 3-7 days.
Duration of Action	Iron stores replenished for months; therapeutic effect lasts until iron is utilized or lost. Clinical note: duration depends on ongoing iron losses.

Classification & Brands

Action Class	Haemopoetic agents
Brand Substitutes	Scopink 100mg Injection, Vipron-S Injection, Zincobus 100mg Injection, Irosyl 100mg Injection, Uniraut 100mg Injection

Dosing & administration

Adult: 5 mL (100 mg elemental iron) IV push at 1 mL/min or IV infusion over 15-30 minutes, given 1-3 times per week to a total cumulative dose based on iron deficit calculation using Ganzoni formula.

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment required for GFR >30 mL/min; for dialysis-dependent patients, administer during dialysis session. No data for GFR <30 mL/min not on dialysis.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B or C: use with caution due to increased risk of iron overload and adverse effects; consider reduced dose or extended interval.
Pediatric use	Weight-based: 0.1 mL/kg (2 mg/kg) elemental iron IV, maximum 2 mL (40 mg) per dose. Administer IV push at 1 mL/min or IV infusion over 15 minutes. Dose frequency and total cumulative dose per iron deficit.
Geriatric use	No specific dose adjustment; start at lower end of dosing range (e.g., 50 mg IV) due to potential for comorbidities and reduced tolerability; monitor for hypotension and infusion reactions.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VENOFER (VENOFER).

Breastfeeding	Iron sucrose is excreted in breast milk in trace amounts. M/P ratio not established. Considered compatible with breastfeeding; monitor infant for gastrointestinal effects.
Teratogenic Risk	Pregnancy Category B. No evidence of teratogenicity in animal studies. In pregnant women, iron sucrose should be used only if clearly needed. Risk of fetal harm is low, but avoid first trimester if possible.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Serious hypersensitivity reactions, including anaphylactic-type reactions, have occurred. Fatal reactions have been reported. Emergency equipment and trained personnel must be available during administration.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to VENOFER or any of its components","Evidence of iron overload (e.g., hemochromatosis, hemosiderosis)","Anemia not caused by iron deficiency (e.g., thalassemia, sideroblastic anemia)"]

Clinical Precautions

Precautions

["Hypersensitivity reactions including anaphylaxis","Hypotension (especially with rapid IV administration)","Iron overload (monitor iron indices)","Risk of extravasation (may cause brown discoloration and pain at injection site)"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

VENOFER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VENOFER (VENOFER).

How it works

What the body does with it

Metabolism	Iron sucrose is dissociated into iron and sucrose by the reticuloendothelial system. Iron is incorporated into hemoglobin or stored as ferritin. Sucrose is excreted renally.
Excretion	Primarily reticuloendothelial system; iron is incorporated into hemoglobin and stored as ferritin/hemosiderin. Minimal renal excretion (<1% unchanged). Fecal elimination negligible. Small amounts lost via desquamation, blood loss, and menstruation.
Half-life	5-6 hours (initial phase, redistribution); terminal half-life ~14 hours (iron clearance from plasma). Clinical context: reflects iron utilization and storage, not elimination of drug.
Protein binding	Binds to transferrin for transport; after release, iron binds to ferritin and hemosiderin. Overall protein binding is >90% (mainly to transferrin).
Volume of Distribution	Vd approximately 3.0-3.4 L/kg in iron-deficiency anemia. Reflects extensive distribution into reticuloendothelial system and bone marrow.
Bioavailability	Intravenous only; oral bioavailability is 0% as sucrose formulation cannot be absorbed. Not administered via other routes.
Onset of Action	IV administration: Hemoglobin increase detectable within 1-2 weeks; reticulocyte response in 3-7 days.
Duration of Action	Iron stores replenished for months; therapeutic effect lasts until iron is utilized or lost. Clinical note: duration depends on ongoing iron losses.

Classification & Brands

Action Class	Haemopoetic agents
Brand Substitutes	Scopink 100mg Injection, Vipron-S Injection, Zincobus 100mg Injection, Irosyl 100mg Injection, Uniraut 100mg Injection

Dosing & administration

Adult: 5 mL (100 mg elemental iron) IV push at 1 mL/min or IV infusion over 15-30 minutes, given 1-3 times per week to a total cumulative dose based on iron deficit calculation using Ganzoni formula.

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment required for GFR >30 mL/min; for dialysis-dependent patients, administer during dialysis session. No data for GFR <30 mL/min not on dialysis.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B or C: use with caution due to increased risk of iron overload and adverse effects; consider reduced dose or extended interval.
Pediatric use	Weight-based: 0.1 mL/kg (2 mg/kg) elemental iron IV, maximum 2 mL (40 mg) per dose. Administer IV push at 1 mL/min or IV infusion over 15 minutes. Dose frequency and total cumulative dose per iron deficit.
Geriatric use	No specific dose adjustment; start at lower end of dosing range (e.g., 50 mg IV) due to potential for comorbidities and reduced tolerability; monitor for hypotension and infusion reactions.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VENOFER (VENOFER).

Breastfeeding	Iron sucrose is excreted in breast milk in trace amounts. M/P ratio not established. Considered compatible with breastfeeding; monitor infant for gastrointestinal effects.
Teratogenic Risk	Pregnancy Category B. No evidence of teratogenicity in animal studies. In pregnant women, iron sucrose should be used only if clearly needed. Risk of fetal harm is low, but avoid first trimester if possible.
Fetal Monitoring