IV Monoferric (Ferric Derisomaltose) Dosing
Monoferric (ferric derisomaltose) is administered as a single high-dose infusion based on body weight and hemoglobin level, with doses ranging from 500 mg to 1500 mg, making it the most convenient IV iron formulation available. 1
Important Clarification: Monoferric vs. Iron Sucrose
The question asks about "Monoferric" but then references "iron sucrose" in parentheses. These are two completely different IV iron formulations with distinct dosing protocols. Monoferric is the brand name for ferric derisomaltose (iron isomaltoside), while iron sucrose is marketed as Venofer. 1, 2 The dosing differs dramatically between these products.
Monoferric (Ferric Derisomaltose) Dosing for Adults
Standard Dosing Algorithm
For patients ≥50 kg:
- Hemoglobin >10 g/dL: Administer 1000 mg as a single dose 1
- Hemoglobin ≤10 g/dL: Administer 1500 mg as a single dose 1
For patients <50 kg:
- Hemoglobin >10 g/dL: Administer 500 mg as a single dose 1
- Hemoglobin ≤10 g/dL: Administer 1000 mg as a single dose 1
Administration Details
- Infusion time for doses ≤1000 mg: Minimum 20 minutes 1
- Infusion time for doses >1000 mg: Minimum 30 minutes 1
- No test dose required 1
- Maximum single dose: 20 mg/kg body weight 1
Key Advantage Over Other Formulations
Monoferric is the only IV iron formulation with FDA approval for total dose infusion, allowing complete iron repletion in a single visit rather than requiring 4-7 visits as with iron sucrose. 1 This represents a major practical advantage for patient compliance and healthcare efficiency. 1
Iron Sucrose Dosing (If This Is What You Actually Need)
Standard Dosing Protocol
- Maximum single dose: 200 mg per injection 3, 2
- Minimum infusion time: 30 minutes for 200 mg dose 3
- Alternative rapid administration: 2-5 minute IV push (approved but less commonly used) 3, 2, 4
- Maximum weekly dose: 500 mg 2
- Test dose: Not required (unlike iron dextran) 3, 2
Typical Repletion Course
For hemodialysis patients with CKD:
- Administer 100-125 mg IV at every hemodialysis session for 8-10 doses 3
- Total cumulative dose typically 1000 mg over 2-3 weeks 3
For non-dialysis patients:
- Administer 200 mg weekly for 5 doses to achieve 1000 mg total 5
- Requires 4-7 clinic visits for complete iron repletion 3, 2
Special Population Dosing
Chronic Kidney Disease on Dialysis
Monoferric: Dose based on 20 mg/kg body weight 1
Iron sucrose:
- Maintenance dosing: 25-125 mg IV once weekly after initial repletion 3
- Target transferrin saturation >20% and ferritin >100 ng/mL 3
Pediatric Patients
Iron sucrose (most studied in children):
- Approved in USA: Children ≥2 years of age 3, 2
- Recommended dose: 200-250 mcg/kg/day if given daily in PN, or 50-100 mcg/kg/day up to maximum 5 mg/day 3
- For intermittent infusions: 200 mg per dose, 2-3 times weekly 2
- Maximum single dose: 200 mg to minimize anaphylactoid reactions 2
- No IV iron preparation is currently approved for pediatric use in Europe, though iron sucrose is used off-label 3
Pregnancy
Specific pregnancy dosing for Monoferric or iron sucrose is not well-defined in the provided guidelines. However, IV iron is generally preferred over oral iron in pregnant patients with hemoglobin <10 g/dL or intolerance to oral iron. 3
Total Iron Deficit Calculation
Simple Dosing Scheme (Preferred for Ferric Carboxymaltose/Monoferric)
This simplified approach has shown better efficacy and compliance compared to Ganzoni formula calculations: 3
| Hemoglobin (g/dL) | Body Weight <70 kg | Body Weight ≥70 kg |
|---|---|---|
| 10-12 (women) / 10-13 (men) | 1000 mg | 1500 mg |
| 7-10 | 1500 mg | 2000 mg |
Important limitation: Patients with hemoglobin <7.0 g/dL likely need an additional 500 mg beyond these estimates. 3
Traditional Ganzoni Formula (Less Practical)
The Ganzoni formula is inconvenient, prone to error, inconsistently used, and underestimates iron requirements in clinical practice. 3 The simple weight-based scheme above is preferred for modern high-dose IV iron formulations. 3
Monitoring and Follow-Up
Initial Response Assessment
- Check hemoglobin at 4 weeks after starting therapy to confirm adequate response 3, 2
- Do not check iron parameters within first 4 weeks after IV iron administration, as circulating iron interferes with assay results 1
- Optimal timing for iron studies: 4-8 weeks post-infusion 1
Long-Term Monitoring
- First year: Monitor every 3 months 1, 2
- Years 2-3: Monitor every 6-12 months 1, 2
- Re-treatment threshold: Initiate when ferritin drops <100 μg/L or hemoglobin <12 g/dL (women) or <13 g/dL (men) 1
Target Parameters
- Transferrin saturation: >20% 3, 1
- Serum ferritin: >100 ng/mL but preferably not exceeding 500-800 ng/mL to avoid toxicity 3, 1
- Upper safety limits: Withhold IV iron if transferrin saturation >50% and/or ferritin >800 ng/mL 3
Absolute Contraindications
- Active bacteremia or bloodstream infection 1, 2
- Hemoglobin >15 g/dL 1
- Known hypersensitivity to the specific formulation 2
Important distinction: Chronic infection alone is not an absolute contraindication if risk/benefit favors treatment. 2 However, withhold therapy during active bacteremia. 2
Safety Considerations
Monoferric Safety Profile
- Hypophosphatemia incidence: 4% (lower than ferric carboxymaltose at 58%, higher than iron sucrose at 1%) 2
- Demonstrated cardiovascular benefit: Statistically significant reduction in death from cardiovascular events in heart failure patients 1
- No test dose required 1
Iron Sucrose Safety Profile
- Hypersensitivity reactions: Approximately 0.5% incidence 2, 6
- Common adverse effects: Hypotension, nausea, vomiting, diarrhea 2
- Serious adverse events: Rare, with excellent safety profile even in patients with prior iron dextran sensitivity 4, 7
- Hypophosphatemia: Only 1% incidence (lowest among IV iron formulations) 3, 2
Management of Minor Infusion Reactions
- Stop the infusion immediately 2
- Switch to hydration fluid to keep vein open 2
- Monitor vital signs 2
- Most reactions are self-limiting and resolve spontaneously within 15 minutes 2
- After 15 minutes: Consider rechallenge with careful monitoring 2
- If symptoms persist or worsen: Administer IV hydrocortisone 2
Critical pitfall to avoid: Do not inappropriately intervene with vasopressors and H1 blockers for minor complement activation-related pseudo-allergy (CARPA) reactions, as this converts minor reactions into hemodynamically significant adverse events. 8
Clinical Decision Algorithm
Step 1: Choose the appropriate formulation
- Prefer Monoferric (ferric derisomaltose) for single-dose convenience and proven cardiovascular benefit 1
- Consider iron sucrose if cost is a major concern (£102 vs £169.50 per 1000 mg) or if patient has prior tolerance to this specific formulation 3, 2
Step 2: Verify no contraindications
Step 3: Calculate dose
- Use weight-based and hemoglobin-based algorithm above 1
Step 4: Administer with appropriate monitoring
- Have resuscitation equipment immediately available 2
- Monitor vital signs during and for 30 minutes after infusion 2
Step 5: Follow-up