For an adult with non‑dialysis chronic kidney disease and iron‑deficiency anemia, should I use Monoferric (ferric‑derisomaltose) or Venofer (iron‑sucrose)?

Monoferric vs Venofer for Non-Dialysis CKD with Iron-Deficiency Anemia

Choose Monoferric (ferric derisomaltose) over Venofer (iron sucrose) for adults with non-dialysis chronic kidney disease and iron-deficiency anemia, as it requires only a single 1000 mg infusion over 20 minutes compared to up to 5 separate visits for iron sucrose, while demonstrating comparable efficacy, similar safety, and significantly fewer cardiovascular adverse events. 1, 2

Key Practical Advantages of Monoferric

Monoferric allows administration of 1000 mg in a single 20-minute infusion, whereas Venofer requires multiple 200 mg doses (typically 5 visits over 2 weeks) to deliver the same total iron dose. 3, 4, 5 This represents a substantial reduction in healthcare utilization and patient burden.

• Monoferric has the highest iron concentration (100 mg/mL) among available IV iron formulations, enabling high-dose single administration 3, 4
• The FDA-approved dosing for Monoferric is 1000 mg as a single dose for patients ≥50 kg with hemoglobin >10 g/dL, or 1500 mg total for those with hemoglobin ≤10 g/dL 6, 5
• Iron sucrose is limited to maximum 200 mg per dose, requiring 4-7 clinic visits for complete iron repletion 4, 7

Safety Profile: Comparable with Important Cardiovascular Advantage

The FERWON-NEPHRO trial (1,538 patients with NDD-CKD) demonstrated that serious or severe hypersensitivity reactions were equally rare with both formulations (0.3% for Monoferric vs 0% for iron sucrose, P>0.05), but Monoferric was associated with significantly fewer cardiovascular adverse events. 2

• Composite cardiovascular adverse events occurred in 4.1% of Monoferric patients versus 6.9% of iron sucrose patients (P=0.025) 2
• Time to first cardiovascular adverse event was significantly longer with Monoferric (hazard ratio 0.59,95% CI 0.37-0.92, P=0.0185) 1
• This cardiovascular safety advantage was consistent in patients both with and without heart failure (P=0.908 for interaction) 1
• Both formulations showed similar rates of treatment-related adverse events (7.1% for Monoferric in maintenance therapy studies) 8

Efficacy: Non-Inferior with Faster Hematological Response

Monoferric demonstrated non-inferior hemoglobin increase at 8 weeks compared to iron sucrose (mean change 1.22 g/dL vs 1.14 g/dL), while achieving significantly faster early hematological response. 5, 2

• Monoferric produced a more pronounced hemoglobin increase during the first 4 weeks compared to iron sucrose (P≤0.021) 2
• Ferritin levels increased significantly more with Monoferric at weeks 1,2, and 4 (P<0.001 at weeks 1-2, P=0.002 at week 4) 9
• Reticulocyte count showed significantly greater increase with Monoferric at week 1 (P<0.001), indicating more rapid erythropoietic response 9
• Both formulations maintained >82% of patients with hemoglobin in target range (9.5-12.5 g/dL) at 6 weeks 9

Dosing Algorithm for Monoferric

For patients with NDD-CKD and iron-deficiency anemia:

• Weight ≥50 kg, Hb >10 g/dL: Administer 1000 mg as single dose over 20 minutes 6, 5
• Weight ≥50 kg, Hb ≤10 g/dL: Administer 1500 mg total (1000 mg initially, then 500 mg after ≥7 days) 6, 5
• Weight <50 kg, Hb >10 g/dL: Administer 500 mg as single dose 6
• Weight <50 kg, Hb ≤10 g/dL: Administer 1000 mg total (can be given as single dose over 30 minutes) 6

Dosing Algorithm for Iron Sucrose (If Chosen)

• Administer 200 mg per dose via IV injection over 2-5 minutes or diluted infusion 3
• Repeat doses up to 5 times within 2-week period to achieve 1000 mg total 2
• Requires 4-7 clinic visits for complete iron repletion 4

Monitoring Recommendations

Check hemoglobin and iron parameters (ferritin, transferrin saturation) at 4-8 weeks post-infusion, not earlier. 6

• Do not evaluate iron parameters within first 4 weeks as circulating iron interferes with assay accuracy 10, 6
• Expect hemoglobin increase of 1-2 g/dL within 4-8 weeks 10
• For chronic conditions with ongoing iron losses, monitor every 3 months for first year, then every 6 months 6
• Re-treat when ferritin drops below 100 μg/L or hemoglobin falls below normal range 6

Important Clinical Caveats

Withhold IV iron during active infections, as patients with bacteremia were excluded from clinical trials. 3

• Do not administer if hemoglobin >15 g/dL 10, 6
• Observe patients for at least 30 minutes post-infusion for hypersensitivity reactions 10
• Unlike ferric carboxymaltose, Monoferric has lower rates of treatment-emergent hypophosphatemia (4% vs 58%) 10
• Monoferric is the only IV iron formulation with FDA approval for total dose infusion 6

Cost-Effectiveness Consideration

While Monoferric has higher acquisition cost per gram of iron compared to iron sucrose, the single-visit administration model reduces overall healthcare costs through decreased clinic visits, nursing time, and patient time burden. 10 The significantly lower cardiovascular adverse event rate may further reduce downstream healthcare utilization. 1, 2