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November 16, 2025
Brand Name :
Monoferric
Synonyms :
ferric derisomaltose
Class :
Iron Products
Dosage Forms & Strengths 
Injectable solution
100mg elemental iron/mL
Wt < 50 kg: 20 mg/kg intravenous infusion 
Wt > 50 kg: 1000 mg intravenous infusion 
If iron deficiency anemia reappears, repeat the dosage. 
Note:  Indicated for people with iron deficiency anemia who are intolerant to oral iron or who have not responded satisfactorily to oral iron 
Additionally recommended for persons with non-hemodialysis dependent chronic renal disease who have iron deficient anemia  
Safety and efficacy not established
Refer to adult dosing
Actions and Spectrum:
ferric derisomaltose is an iron-based carbohydrate complex used as a treatment for iron deficiency anemia. Its actions include:
The spectrum of ferric derisomaltose includes:
Frequency Defined 
1-10% 
Hypophosphatemia (3.5%)
Nausea (1.2%)
Rash (1%)
Post marketing Reports
Nausea and vomiting
Abdominal pain
Fatigue
Tachycardia
Diarrhea
Pyrexia
Anaphylactic/anaphylactoid reaction
chest pain
Hypersensitivity
Hepatic enzymes increased
Anxiety
Black Box Warning
ferric derisomaltose is a medication used for the treatment of iron deficiency anemia. A black box warning is a type of warning issued by the US Food and Drug Administration (FDA) to indicate that a medication has serious or life-threatening risks.
Contraindication/Caution:
ferric derisomaltose is contraindicated in individuals with known hypersensitivity to iron or maltose. It should also be used with caution in patients with liver or renal dysfunction, as well as those with a history of hemosiderosis.
Individuals with iron overload disorders, such as hemochromatosis, should not receive this medication. Additionally, individuals who have recently received intravenous iron should wait at least 7 days before receiving ferric derisomaltose.
Pregnancy warnings:   
US FDA pregnancy category: N/A
Lactation:  
Excreted into human milk is known
Pregnancy Categories:        
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology: 
ferric derisomaltose is an iron-based drug used for the treatment of iron deficiency anemia
Pharmacodynamics: 
Mechanism of action: ferric derisomaltose is a complex of iron and a carbohydrate, derisomaltose, which provides a slow and sustained release of iron into the body. This helps increase the iron levels in the blood and replenish the body’s iron stores.
Pharmacokinetics:  
Absorption 
ferric derisomaltose is rapidly absorbed from the gut into the bloodstream.
Distribution 
Hemosiderin/ferritin, the physiological forms of iron storage, are formed when iron is bound to the relevant protein moieties, or, to a lower extent, toward the transport molecule transferrin.
Metabolism 
Not known
Elimination and excretion 
The iron is gradually released from the complex and transported to the tissues where it is needed. The drug has a half-life of approximately 2-3 days.
Administration: 
Oral/IV administration
ferric derisomaltose is administered intravenously in a healthcare setting. The dose and duration of treatment are determined based on the patient’s individual needs and response to treatment.
Patient information leaflet
Generic Name: ferric derisomaltose
Why do we use ferric derisomaltose?
ferric derisomaltose is a medication that is used to treat Iron Deficiency Anemia. ferric derisomaltose provides iron to the body to help replenish iron stores and increase hemoglobin levels.