VENOFER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VENOFER (VENOFER).
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.
| 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. |
| Molecular Weight | 34000 Da (34 kDa) |
| Action Class | Haemopoetic agents |
| Brand Substitutes | Scopink 100mg Injection, Vipron-S Injection, Zincobus 100mg Injection, Irosyl 100mg Injection, Uniraut 100mg Injection |
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. |
| 1st trimester | Iron sucrose complex is not systemically absorbed; however, fetal risk cannot be ruled out. Use only if clearly needed. |
| 2nd trimester | No known teratogenicity; administer if maternal benefit outweighs potential fetal risk. |
| 3rd trimester | Use in third trimester is common for iron deficiency anemia; no increased fetal risk reported. |
Clinical note
Comprehensive clinical and safety monograph for VENOFER (VENOFER).
| Placental transfer | Iron sucrose complex does not cross the placenta in significant amounts due to its large molecular size and carbohydrate shell. |
| Breastfeeding | Iron sucrose is minimally excreted into breast milk (<1% of maternal dose). Considered compatible with breastfeeding; monitor infant for gastrointestinal effects. |
■ 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.
| Serious Effects |
Known hypersensitivity to iron sucrose or any of its excipientsEvidence of iron overload (e.g., hemochromatosis, hemosiderosis)Anemia not caused by iron deficiency (e.g., hemolytic anemia)
| 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) |
| Food/Dietary | No significant food interactions. However, to enhance iron absorption from dietary sources, avoid consuming tea, coffee, or calcium-rich foods within one hour of oral iron supplements (if also prescribed). Since VENOFER is intravenous, food does not affect its absorption. Maintain a balanced diet rich in vitamin C to support iron utilization. |
Loading safety data…
| Lactation Rating |
| L2 (Safer) |
| 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 | Monitor maternal hemoglobin, hematocrit, ferritin, and blood pressure during infusion. Assess for hypersensitivity reactions. Fetal monitoring not routinely required. |
| Fertility Effects | No known adverse effects on fertility. May improve fertility in iron-deficient anemic patients by correcting underlying deficiency. |
| Clinical Pearls | VENOFER (iron sucrose) is indicated for iron deficiency anemia in patients with chronic kidney disease (CKD). Do not administer concurrently with oral iron supplements; separate by at least 1 hour. Monitor for hypersensitivity reactions, especially in patients with known drug allergies. Hypotension may occur during infusion; slow infusion rate if needed. Test dose not required but observe patient for 30 minutes post-infusion. Do not mix with other medications or dilute in more than 100 mL of normal saline. Use with caution in patients with iron overload or hepatic impairment. |
| Patient Advice | VENOFER is used to treat low iron and anemia, especially in kidney disease. · It is given as an intravenous infusion over at least 15–30 minutes. · You may experience side effects like nausea, cramping, or a metallic taste. · Report any signs of allergic reaction: rash, itching, difficulty breathing, or swelling. · Do not take oral iron supplements while on this medication without doctor approval. · Keep all follow-up appointments to monitor your iron levels and kidney function. |