Ferric Derisomaltose (Monoferric) IV Treatment Duration
Ferric derisomaltose (Monoferric) is typically administered as a single intravenous dose of 1000 mg or up to 20 mg/kg (not exceeding 1500 mg) with no need for multiple-day treatment courses. 1, 2
Dosing and Administration Details
Ferric derisomaltose offers the advantage of complete iron repletion in a single infusion:
- Standard dosing: 1000 mg or up to 20 mg/kg (maximum 1500 mg) 1, 2
- Administration time: 15-30 minutes 3
- Dilution: Should be diluted in 100 mL of normal saline 1
- No test dose required before administration
This is in contrast to older IV iron formulations that often require multiple administrations over several days:
| Preparation | Maximum Single Dose | Administration Time |
|---|---|---|
| Ferric Derisomaltose (Monoferric) | 20 mg/kg (up to 1500 mg) | 15-30+ minutes |
| Ferric Carboxymaltose (Injectafer) | 750 mg (US) | 15 minutes |
| Iron Sucrose (Venofer) | 200 mg | Multiple doses needed |
| Ferumoxytol (Feraheme) | 510 mg | Multiple doses needed |
Monitoring After Administration
After the single-dose administration of ferric derisomaltose:
- Laboratory evaluation: Check CBC and iron parameters (ferritin, TSAT) 4-8 weeks after infusion 1
- Expected response: Hemoglobin should increase by 1-2 g/dL within 4-8 weeks 1
- Avoid early testing: Iron parameters should not be evaluated within 4 weeks of administration as circulating iron can interfere with assay results 1
Repeat Dosing Considerations
While a single dose is typically sufficient, repeat dosing may be necessary in certain situations:
- Ongoing blood loss: Patients with conditions such as heavy menstrual bleeding or inflammatory bowel disease may require repeated administrations 1, 3
- Malabsorption conditions: Patients with conditions that inhibit iron absorption (bariatric surgery, autoimmune gastritis, celiac disease) may need repeated doses 1
- Frequency of repeat dosing: Depends on the degree of blood loss or malabsorption and should be guided by follow-up laboratory testing 1
Clinical Efficacy
The efficacy of single-dose ferric derisomaltose has been demonstrated in multiple clinical trials:
- In patients with non-dialysis dependent chronic kidney disease, a single infusion of ferric derisomaltose was as effective as multiple doses of iron sucrose 4
- Patients achieved faster hematological response with ferric derisomaltose versus iron sucrose 4
- FDA approval was based on trials showing non-inferiority for change in hemoglobin from baseline to Week 8 compared to iron sucrose 2
Safety Considerations
- Common side effects: Dizziness, headache, hypertension, injection-site reactions, and nausea 3
- Monitoring: Observe patients for hypersensitivity reactions during and for at least 30 minutes after administration 3
- Cardiovascular safety: Time to first cardiovascular adverse event is longer with ferric derisomaltose compared to iron sucrose 4
- Hypophosphatemia: Less frequent with ferric derisomaltose compared to other IV iron formulations 5
The key advantage of ferric derisomaltose is the ability to deliver complete iron repletion in a single visit, improving patient convenience and potentially reducing healthcare costs compared to multiple-day regimens required with other IV iron formulations.