Ferric Derisomaltose

Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

• Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron. ( 1 ) who have non-hemodialysis dependent chronic kidney disease.ICD-10: D64.9, E61.1, N18.9

• Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1) , Description (11) ) . Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.contraindicated

For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric as an intravenous infusion. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight as an intravenous infusion. Repeat Monoferric treatment if iron deficiency anemia reoccurs. ( 2 ) 2.1 Recommended Dosage For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions ( Warnings and Precautions (5.1) ) . 2.2 Preparation and Administration Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Monoferric is single-dose only. Discard unused portion. Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP. Final diluted concentration should be more than 1 mg iron/mL. Compatibility of Monoferric with other drugs has not been established.

Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. ( 5.1 ) Iron Overload: Do not administer Monoferric to patients with iron overload. ( 5.2 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components ( see Contraindications (4) ). In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient. 5.2 Iron Overload Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions (see Warnings and Precautions (5.1) ) . Iron Overload (see Warnings and Precautions (5.2) ) . Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The safety of Monoferric was evaluated in 3008 patients with iron deficiency anemia enrolled in two randomized, actively-controlled trials. Trial 1 enrolled adult patients with iron deficiency anemia with intolerance to oral iron or had an unsatisfactory response to oral iron with a clinical need for repletion of iron stores. Eligible subjects were required to have a baseline hemoglobin of ≤11g/dl, transferrin saturation (TSAT) of less than 20% and serum ferritin level of <100 ng/mL. Trial 2 enrolled adult patients with non-dialysis dependent chronic kidney disease (CKD) with iron deficiency anemia ( see Clinical Studies (14) ). Eligible subjects also had to have serum ferritin ≤100 ng/mL or ≤300 ng/mL if TSAT ≤30%.

8.1 Pregnancy Risk Summary There are no available data on Monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see Data ) . There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ) . Iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. The findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency. Animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (MRHD) of 1000 mg, respectively, based on body surface area ( see Data ) .

Metabolism

The pharmacokinetics of total iron (derisomaltose-bound plus transferrin-bound iron) were evaluated in adult patients with IDA. After a single dose of Monoferric, maximum concentration (C max ) and area under the concentration time curve (AUC) of serum total iron increased approximately proportionally over the 100 to 1000 mg dose range.

Excessive dosages of Monoferric may lead to accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Monoferric in patients with iron overload (see Warnings and Precautions (5.2) ) .

• Jan 16, 2020NDANDA208171Pharmacosmos

1. 1Dyspnoea25921%
2. 2Flushing14512%
3. 3Nausea14011%
4. 4Chest Discomfort13111%
5. 5Back Pain1179.5%
6. 6Infusion Related Reaction977.8%
7. 7Dizziness917.4%
8. 8Pruritus816.5%
9. 9Chest Pain806.5%
10. 10Vomiting786.3%
11. 11Hypersensitivity655.3%
12. 12Abdominal Pain645.2%
13. 13Headache604.9%
14. 14Oxygen Saturation Decreased584.7%
15. 15Rash574.6%

The 10 most recently updated of 39 ClinicalTrials.gov registrations naming Ferric Derisomaltose as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Intravenous Iron to Improve Symptoms, Quality of Life and Exercise Capacity in HFpEF With Iron Deficiency
  Not yet recruiting · Phase 2 · Interventional · 150 enrolled · Government of Jersey
  NCT07643818updated 2026-06-12
• The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
  Recruiting · Phase 4 · Interventional · 210 enrolled · Soren Overgaard
  NCT06898814updated 2026-06-01
• Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
  Recruiting · Phase 3 · Interventional · 30 enrolled · Hull University Teaching Hospitals NHS Trust
  NCT06884280updated 2026-05-06
• Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
  Recruiting · Phase 4 · Interventional · 310 enrolled · dr. P. Noordzij
  NCT04913649updated 2026-04-27
• Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
  Recruiting · Phase 3 · Interventional · 200 enrolled · Pharmacosmos A/S
  NCT05179226updated 2026-04-14
• Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)
  Recruiting · Phase 4 · Interventional · 66 enrolled · Massachusetts General Hospital
  NCT04945707updated 2026-02-19
• Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
  Recruiting · Phase 2 · Interventional · 60 enrolled · University Health Network, Toronto
  NCT06287619updated 2026-02-10
• The Effect of Preoperative Intravenous Ferric Derisomaltose and EPO and Tranexamic Acid in Patients With Preoperative Anemia or Iron Deficiency in Bone Tumor
  Not yet recruiting · Phase 4 · Interventional · 160 enrolled · Tang Xiaodong
  NCT07314424updated 2026-01-02
• Methemoglobinemia Following Intravenous Iron Treatment
  Completed · Observational · 50 enrolled · Claudia Seiler
  NCT06309641updated 2025-12-09
• Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery
  Not yet recruiting · Phase 4 · Interventional · 180 enrolled · Yonsei University
  NCT07238972updated 2025-11-20

Frequently asked questions

How does Ferric Derisomaltose work?

Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

What is Ferric Derisomaltose used for?

According to FDA labeling, Ferric Derisomaltose carries indications including: Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron. ( 1 ) who have non-hemodialysis dependent chronic kidney disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Ferric Derisomaltose?

Ferric Derisomaltose is marketed under brand names including Monoferric.

What are the contraindications for Ferric Derisomaltose?

Ferric Derisomaltose labeling lists contraindications including: Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1) , Description (11) ) . Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.. Always consult the full prescribing information and a clinician.