What is Venofer?
Venofer (iron sucrose) is an intravenous iron replacement product specifically indicated for treating iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). 1
Formulation and Administration
Venofer is supplied as 100 mg/5 mL (20 mg/mL) of elemental iron in single-dose vials for intravenous use only 1. The iron is bound to a sucrose complex, which allows for safer administration compared to older iron dextran formulations 2.
Dosing by Patient Population
Adult Patients:
- Hemodialysis-dependent CKD (HDD-CKD): 100 mg by slow IV injection or infusion 1
- Non-dialysis-dependent CKD (NDD-CKD): 200 mg by slow IV injection or infusion 1
- Peritoneal dialysis-dependent CKD (PDD-CKD): 300-400 mg by IV infusion 1
Pediatric Patients:
- All CKD categories: 0.5 mg/kg by slow IV injection or infusion 1
- Approved in the USA for children ≥2 years of age 2
Administration Details
Venofer can be administered as a bolus injection of 200 mg over 10 minutes, which is more convenient than the traditional 2-hour infusion 3. Importantly, no test dose is required before administration, unlike iron dextran formulations 4. The maximum single dose is 200 mg with a maximum weekly dose of 500 mg 5.
Safety Profile
Venofer is considered safer than iron dextran, with fewer adverse effects and no reported anaphylaxis in initial studies 3. The most recently introduced iron compounds including iron sucrose have significantly less adverse effects than older iron dextran preparations 2.
Common Adverse Reactions
In adults (≥2%): diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema 1.
In pediatric patients (≥2%): headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension 1.
Critical Safety Considerations
Hypersensitivity reactions can occur—observe patients for at least 30 minutes after administration and ensure resuscitation facilities are immediately available 1. While anaphylaxis is exceedingly rare (occurring in <1:200,000 administrations) 6, the most common infusion reaction is complement-activated related pseudo-allergy (CARPA), which is physiologically different from true anaphylaxis 6.
Monitor for hypotension during and after each administration 1. Do not administer to patients with iron overload—regularly monitor hematologic responses during therapy 1.
Clinical Efficacy
Iron sucrose is the most studied intravenous iron preparation in children, with 232 children receiving 1624 doses across 6 studies showing very few serious adverse reactions 2. In one randomized study of 145 children, adolescents, and young adults, no patient experienced an anaphylactic reaction 2.
In adult dialysis patients, iron sucrose produces a significant increase in hemoglobin that becomes evident after three doses and persists at least 5 weeks after the 10th dose 7. Transferrin saturation and ferritin levels also increase significantly and remain elevated 7.
Broader Applications
While FDA-approved specifically for IDA in CKD patients 1, iron sucrose has been used effectively across various conditions including inflammatory bowel disease, pregnancy (second and third trimester), postpartum period, heavy menstrual bleeding, and cancer-related anemia 8. It is particularly useful when oral iron is ineffective, not tolerated, or when rapid iron repletion is needed 8.
Contraindications
The only contraindication is known hypersensitivity to Venofer 1.