Version July 2025
Note: Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, poor GI absorption, lack of response to or poor tolerability of oral iron, need for rapid repletion, chronic kidney disease, active inflammatory bowel disease, cancer, chronic or extensive blood loss) (Ref). Dosage expression: Dose is expressed in mg of elemental iron. Test dose: A test dose is not required.
Iron-deficiency anemia, treatment: IV:
≥50 kg: 1 g as a single dose (Ref) or up to 3 doses of 500 mg administered over 7 days (Ref).
<50 kg: 20 mg/kg as a single dose.
Canadian labeling: Cumulative dose may be determined using the Ganzoni formula or Simplified Dosing Table, or by using a fixed dose based on weight (see dosing above). In clinical studies described in the Canadian labeling, the Ganzoni formula was used in patients with chronic kidney disease (Ref) and the Simplified Dosing Table was used in patients with iron-deficiency anemia from other causes (Ref).
Ganzoni formula:
Iron need (mg) = BW (kg) × (target Hb [g/dL] – actual Hb [g/dL]) × 2.4 + iron stores (mg)a
BW= weight in kg; for individuals with obesity, use ideal body weight
aFor patients >35 kg, the iron stores are 500 mg or above. Some guidelines suggest using 10 to 15 mg iron/kg body weight and others suggest 1 g iron as stores.
Simplified Dosing Table:
|
Hb (g/dL) |
Weight <50 kg |
Weight 50 to <70 kg |
Weight ≥70 kg |
|
≥10 g/dL |
500 mg |
1 g |
1.5 g |
|
<10 g/dL |
500 mg |
1.5 g |
2 g |
Maximum dose:
Nonpregnant patients: Maximum single dose: 1.5 g or 20 mg/kg (whichever is less) (Ref).
Pregnant patients ≥16 weeks' gestation: Maximum single dose: 1 g; maximum cumulative dose: 2 g (Ref).
Note: For administration by IV infusion, administer doses ≤1 g over at least 20 minutes and doses >1 g over at least 30 minutes. For administration by IV bolus, maximum single dose is 500 mg; maximum rate of administration is 250 mg/minute. For either method of administration, if total dose exceeds what can be given in a single administration, administer in divided doses separated by ≥7 days.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling.
US labeling:
There are no dosage adjustments provided in the manufacturer's labeling.
Canadian labeling:
Avoid use in patients with hepatic dysfunction (ALT and/or AST elevations >3 x ULN) where iron overload is the precipitating factor. Use is contraindicated in patients with decompensated liver cirrhosis or active hepatitis.
It is recommended to use ideal body weight in patients with obesity when calculating cumulative doses with the Ganzoni formula (Ref).
Refer to adult dosing, use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Dermatologic: Skin rash (1%)
Endocrine & metabolic: Hypophosphatemia (4%)
Gastrointestinal: Nausea (1%)
<1%: Hypersensitivity: Infusion-related reaction, severe hypersensitivity reaction
Postmarketing:
Cardiovascular: Chest pain, flushing, hypertension, hypotension, phlebitis, syncope, tachycardia
Dermatologic: Diaphoresis, erythema of skin, exfoliation of skin, pruritus, skin discoloration, urticaria
Gastrointestinal: Abdominal pain, constipation, diarrhea, dysgeusia, nausea and vomiting
Hepatic: Increased liver enzymes
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema), nonimmune anaphylaxis
Local: Injection-site reaction
Nervous system: Anxiety, chills, dizziness, fatigue, headache, loss of consciousness, malaise, pain, paresthesia, seizure
Neuromuscular & skeletal: Arthralgia, back pain, muscle spasm, myalgia
Respiratory: Bronchospasm, cough, dyspnea, flu-like symptoms
Miscellaneous: Fever
Serious hypersensitivity to ferric derisomaltose or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Serious hypersensitivity to other parenteral iron products, decompensated liver cirrhosis or active hepatitis; non-iron-deficiency anemia (eg, hemolytic anemia); iron overload (eg, hemochromatosis; hemosiderosis).
Concerns related to adverse effects:
• Extravasation: Avoid extravasation (extravasation may cause local skin irritation or skin discoloration).
• Hypersensitivity/anaphylactoid reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions (some life threatening and fatal) have been reported. Monitor during and for ≥30 minutes after each administration and until clinically stable. Equipment for resuscitation, medication, and trained personnel experienced in handling emergencies should be immediately available during infusion. Discontinue use immediately with signs of hypersensitivity and administer appropriate therapy.
Other warnings/precautions:
• Iron overload: Excessive iron therapy may lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Do not administer iron in the presence of iron overload. Periodic monitoring of hemoglobin, hematocrit, serum ferritin, and transferrin saturation during therapy is recommended.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Monoferric: 1000 mg/10 mL (10 mL)
No
Solution (Monoferric Intravenous)
1000 mg/10 mL (per mL): $421.41
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Monoferric: 100 mg/mL (1 mL, 5 mL, 10 mL)
IV:
Infusion: Administer doses up to 1 g over ≥20 minutes. Administer doses >1 g over ≥30 minutes (Ref). Monitor for signs and symptoms of hypersensitivity reactions during and for ≥30 minutes and until clinically stable following infusion.
IV bolus injection: Single doses up to 500 mg may be administered as a slow IV bolus injection (undiluted or diluted) at a maximum rate of 250 mg/minute (Ref).
Iron-deficiency anemia: Treatment of iron-deficiency anemia in adults who have intolerance to oral iron or unsatisfactory response to oral iron, or those with nonhemodialysis-dependent chronic kidney disease.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Dimercaprol: May increase nephrotoxic effects of Iron Preparations. Risk X: Avoid
Levonadifloxacin: Iron Preparations may decrease serum concentration of Levonadifloxacin. Risk X: Avoid
Iron transfer to the fetus is regulated by the placenta (BSH [Pavord 2020]; NAS 2020).
There is a risk of adverse maternal reactions (eg, anaphylaxis, hypotension, shock) following use of parenteral iron which may result in fetal bradycardia, especially during the second and third trimesters. Although the risk is rare, immediate treatment for anaphylactoid and/or hypersensitivity reactions should be available (BSH [Pavord 2020]). Fetal bradycardia has been observed following maternal administration of ferric derisomaltose (Woodward 2015).
Maternal iron requirements increase during pregnancy. Untreated iron deficiency and iron-deficiency anemia (IDA) in pregnant patients are associated with adverse pregnancy outcomes, including low birth weight, preterm birth, and increased perinatal mortality (ACOG 2021; BSH [Pavord 2020]). Maternal iron deficiency is also associated with fatigue, increased risk of postpartum depression, and possibly postpartum hemorrhage (BSH [Pavord 2020]).
Oral and parenteral iron are effective at replacing iron stores in pregnant patients (ACOG 2021). Most studies note iron therapy improves maternal hematologic parameters, however, data related to clinical outcomes in the mother and neonate are limited (FIGO 2019; NAS 2020; USPSTF [Nicholson 2024]). Parenteral iron therapy may be used in pregnant patients who cannot tolerate or respond to oral iron, when iron deficiency occurs later in pregnancy, or when malabsorption is present (ACOG 2021; BSH [Pavord 2020]).
Ferric derisomaltose has been evaluated for the treatment anemia during pregnancy, including IDA following postpartum hemorrhage (Derman 2025; Hansen 2023; Holm 2017a; Holm 2017b; Holm 2019; Wesström 2020). However, due to limited safety data in early pregnancy, use of intravenous iron is generally not started until the second or third trimester (ACOG 2021; BSH [Pavord 2020]; FIGO 2019). Canadian product labeling provides maximum dosing recommendations for ferric derisomaltose in pregnant patients ≥16 weeks' gestation.
Ferric derisomaltose is present in breast milk.
Endogenous iron concentrations in breast milk vary by postpartum age and are lower than concentrations in the maternal plasma (Dorea 2000; Emmett 1997). Breast milk concentrations of iron are maintained in lactating patients with mild to moderate iron-deficiency anemia (IDA), but concentrations decrease if IDA is moderate to severe (El-Farrash 2012) or severe (Kumar 2008).
Following maternal administration of a single dose of ferric derisomaltose immediately postpartum, breast milk concentrations of iron transiently increased but the mean breast milk concentrations of iron remained within normal limits (Holm 2017c).
Iron deficiency and IDA are associated with adverse effects in postpartum patients (eg, altered cognition, depression, fatigue) that may influence interactions with the infant. Iron supplementation in the postpartum patient should be initiated as soon as possible following delivery when gestational anemia is a concern (WHO 2016). Parenteral iron therapy may be used in postpartum patients with uncorrected anemia at delivery who cannot tolerate, do not respond to, or are noncompliant with oral iron therapy, or the severity of anemia requires prompt management (BSH [Pavord 2020]).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother; monitor breastfed infants for constipation and diarrhea.
CKD patients: Hematocrit, hemoglobin, serum ferritin, serum iron, transferrin, percent transferrin saturation (TSAT), TIBC (takes ~4 weeks of treatment to see increased serum iron and ferritin, and decreased TIBC); iron status should be assessed ≥48 hours after last dose (due to rapid increase in values following administration); signs/symptoms of hypersensitivity reactions (during and ≥30 minutes following infusion); hypotension (during and following infusion). Evaluate iron status (TSAT and ferritin) when deciding to start or continue iron therapy, and at least every 3 months in patients also receiving ESA therapy. Monitor ferritin and TSAT more frequently when monitoring response to IV iron therapy, when initiating or increasing ESA dose, when there is blood loss, and in any other situations where iron stores may become depleted (KDIGO 2012).
Anemia:
Hemoglobin, whole blood:
Female: 12 to 16 g/dL (SI: 120 to 160 g/L) (ABIM 2023).
Male: 13 to 18 g/dL (SI: 130 to 180 g/L) (ABIM 2023; WHO 2011).
Iron deficiency:
Ferritin, serum: Note: Ferritin is an acute phase reactant; levels may be elevated in the presence of inflammation or infection which is independent of iron status (WHO 2020).
Female: 24 to 307 ng/mL (SI: 53.9 to 689.8 picomole/L).
Male: 24 to 336 ng/mL (SI: 53.9 to 755 picomole/L).
Iron, serum: 50 to 150 mcg/dL (SI: 9 to 26.9 micromole/L).
Total iron binding capacity, serum: 250 to 310 mcg/dL (SI: 44.8 to 55.5 micromole/L).
Transferrin saturation: 20% to 50%.
Transferrin, serum: 200 to 400 mg/dL (SI: 24.6 to 49.2 micromole/L).
Chronic kidney disease–associated anemia: To achieve and maintain target hemoglobin for patients with nondialysis-dependent chronic kidney disease, patients with a transferrin saturation (TSAT) ≤30%, and a serum ferritin level ≤500 ng/mL (SI: ≤1,123.5 picomole/L) will often respond to iron supplementation (Gutierrez 2021; KDIGO 2012).
Ferric derisomaltose contains iron and a carbohydrate moiety where the iron is tightly bound in a matrix structure (iron [III] atoms and derisomaltose). The particle is metabolized through the reticuloendothelial system in the liver and spleen which divide the complex into iron and derisomaltose. Iron is immediately bound and stored as ferritin, and derisomaltose moiety is either metabolized or excreted (Kalra 2016).
Onset: Therapeutic response: A few days
Distribution: 3 to 3.5 L (Nordfjeld 2012)
Metabolism: Reticuloendothelial system (RES) in liver and spleen to iron and isomaltoside (Kalra 2016)
Half-life elimination: 1 to 4 days (dose dependent)
Time to peak, serum: 0.57 to 1.53 hours (dose dependent)
Excretion: Urine and feces (negligible)
