What is the recommended dose of ferric derisomaltose for treating iron deficiency anemia?

Ferric Derisomaltose Dosing for Iron Deficiency Anemia

For patients weighing ≥50 kg with hemoglobin >10 g/dL, administer 1000 mg of ferric derisomaltose as a single dose; for those with hemoglobin ≤10 g/dL, administer 1500 mg as a single dose. 1

Weight and Hemoglobin-Based Dosing Algorithm

For Patients Weighing ≥50 kg:

• Hemoglobin >10 g/dL: 1000 mg as a single dose 1
• Hemoglobin ≤10 g/dL: 1500 mg as a single dose 1

For Patients Weighing <50 kg:

• Hemoglobin >10 g/dL: 500 mg as a single dose 1
• Hemoglobin ≤10 g/dL: 1000 mg as a single dose 1

For Chronic Kidney Disease Patients:

• Dose based on body weight at 20 mg/kg 1

Administration Protocol

• Infusion time for doses ≤1000 mg: Administer over at least 20 minutes 1
• Infusion time for doses >1000 mg: Administer over 30 minutes or more 1
• Ferric derisomaltose is the only IV iron formulation with FDA approval for total dose infusion 1

Critical Safety Contraindications

• Do not administer if hemoglobin >15 g/dL 1
• Avoid in patients with hypersensitivity to ferric derisomaltose or excipients 2
• Avoid in patients with evidence of iron overload 2
• Use caution in patients with acute or chronic infection 2

Monitoring and Follow-Up Schedule

Initial Assessment (4-8 weeks post-infusion):

• Check complete blood count and iron parameters (ferritin, transferrin saturation) 1
• Do not evaluate iron parameters within the first 4 weeks after administration, as circulating iron interferes with assay results 1
• Hemoglobin should increase within 1-2 weeks and by 1-2 g/dL within 4-8 weeks 1

Long-Term Monitoring:

• Recheck ferritin and transferrin saturation at next scheduled visit, preferably after 3 months 1
• For chronic conditions with ongoing iron losses (inflammatory bowel disease, chronic kidney disease), monitor every 3 months for at least 1 year after correction 1
• Between 6-12 months thereafter, monitor every 6 months 1

Re-Treatment Criteria

• Initiate re-treatment when serum ferritin drops below 100 μg/L 1
• Or when hemoglobin falls below 12 g/dL (women) or 13 g/dL (men) 1
• For inflammatory bowel disease patients, aim for post-treatment ferritin levels up to 400 μg/L to prevent recurrence 1

Key Clinical Advantages Over Other IV Iron Formulations

• Single-dose administration: A single 1500 mg dose eliminates the need for multiple clinic visits, unlike iron sucrose which requires up to 5 doses of 200 mg 1, 3
• Lower cardiovascular risk: Ferric derisomaltose demonstrates significantly fewer cardiovascular adverse events compared to iron sucrose (4.1% vs 6.9%, P=0.025) 3
• Reduced cardiovascular mortality: Shows statistically significant reduction in death from cardiovascular events in patients with congestive heart failure 1
• Lower hypophosphatemia rates: Hypophosphatemia occurs in only 4% of patients with ferric derisomaltose compared to 58% with ferric carboxymaltose 4

Important Safety Considerations

• Serious or severe hypersensitivity reactions are rare (0.3%) and comparable to iron sucrose 3
• Resuscitation equipment must be immediately available during administration 2
• Observe patients for at least 30 minutes following infusion for adverse effects 2
• Time to first cardiovascular adverse event is significantly longer with ferric derisomaltose compared to iron sucrose (hazard ratio: 0.59,95% CI: 0.37-0.92, P=0.0185) 5

Target Parameters for Successful Iron Repletion

• Transferrin saturation >20% 1
• Serum ferritin >100 ng/mL (but preferably not exceeding 500 mg/L to avoid toxicity) 1
• A total dose of 1000-1500 mg typically restores iron stores to normal in patients with iron deficiency anemia 1