Version May 2024
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.
Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after administration.
Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated.
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:
Single-dose regimen: IV: 1.02 g as a single dose (Ref).
Two-dose regimen: IV: 510 mg once; after 3 to 8 days, administer a second dose of 510 mg once.
Magnetic resonance imaging (off-label use):
Note: Consider for use as an alternative to gadolinium-based contrast agents.
IV: Usual dosage range: 2 to 5 mg/kg; maximum reported dose: 510 mg (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
Hemodialysis: Not removed by hemodialysis; however, administer dose after at least 1 hour of hemodialysis has been completed and once blood pressure has stabilized.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Ferumoxytol: Pediatric drug information")
Note: Dose is expressed in mg of elemental iron.
Magnetic resonance imaging: Limited data available: Infants, Children, and Adolescents: IV: Usual dosage range: 3 to 5 mg/kg/dose as a single dose; reported range: 1 to 11 mg/kg/dose; maximum reported dose: 510 mg/dose (Ref). Dose may vary by type of imaging; the following has been suggested: 3 mg/kg for cardiac MRI and 5 mg/kg for oncologic MRI for adequate tissue enhancement (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function:
Magnetic resonance imaging:
Infants and Children <4 years: Mild to severe impairment: There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; there is no data available for this indication.
Children ≥4 years and Adolescents:
Mild to moderate impairment: There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; there is no data available for this indication.
Severe impairment: There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; based on a pediatric cohort study, no dosage adjustment needed (Ref).
Hemodialysis: Not removed by hemodialysis.
Magnetic resonance imaging:
Infants and Children <4 years: There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; there is no data available for this indication.
Children ≥4 years and Adolescents: There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; based on a pediatric cohort study, no dosage adjustment needed (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Cardiovascular: Chest pain (1%), edema (2%), hypertension (1%), hypotension (≤3%), peripheral edema (2%)
Dermatologic: Pruritus (1%), skin rash (1%)
Gastrointestinal: Abdominal pain (1%), constipation (2%), diarrhea (1% to 4%), nausea (2% to 3%), vomiting (2%)
Hypersensitivity: Hypersensitivity reaction (≤4%; severe hypersensitivity reaction: <1%)
Nervous system: Dizziness (3%), fatigue (2%), headache (2% to 3%)
Neuromuscular & skeletal: Back pain (1%), muscle spasm (1%)
Respiratory: Cough (1%), dyspnea (1%)
Miscellaneous: Fever (1%)
Frequency not defined:
Cardiovascular: Chest discomfort, flushing
Gastrointestinal: Gastroenteritis
Hematologic & oncologic: Acute posthemorrhagic anemia
Nervous system: Seizure
Neuromuscular & skeletal: Arthralgia
Renal: Acute kidney injury
Respiratory: Pneumonia
Postmarketing:
Cardiovascular: Cardiac arrhythmia, heart failure, ischemic heart disease, syncope, tachycardia
Hypersensitivity: Anaphylaxis, angioedema
Nervous system: Loss of consciousness, unresponsive to stimuli
Respiratory: Cyanosis
Hypersensitivity to ferumoxytol, other IV iron products, or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity reactions: [US Boxed Warning]: Serious hypersensitivity reactions, (some fatal), including anaphylaxis may occur, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness even in patients who previously tolerated ferumoxytol. Infuse over ≥15 minutes and have equipment for resuscitation and trained personnel experienced in handling emergencies immediately available during use. Monitor patients for signs/symptoms of hypersensitivity reactions, including blood pressure and pulse during and ≥30 minutes (until clinically stable) following administration. Other hypersensitivity reactions have also occurred (pruritus, rash, urticaria, wheezing). Patients with multiple drug allergies may have greater risk of anaphylaxis; elderly patients with multiple or serious comorbidities who develop hypersensitivity and/or hypotension after ferumoxytol may be at greater risk for serious adverse events.
• Hypotension: Hypotension, including serious hypotensive reactions, may occur; monitor patients for hypotension following administration.
Other warnings/precautions:
• Appropriate use: Do not administer in the presence of tissue iron overload; periodic monitoring of hemoglobin, serum ferritin, serum iron, and transferrin saturation is recommended. Serum iron and transferrin-bound iron may be overestimated in laboratory assays if level is drawn during the first 24 hours following administration.
• Magnetic resonance imaging: Administration may alter MRI; conduct anticipated MRI studies prior to use if using for iron repletion. MRI alterations may persist for ≤3 months following use, with peak alterations anticipated in the first 2 days following administration. If MRI is required within 3 months after administration, use T1- or proton density-weighted magnetic resonance pulse sequences to decrease effect on imaging. Do not use T2-weighted sequence MRI prior to 4 weeks following ferumoxytol administration. Ferumoxytol does not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.
Strength of ferumoxytol is expressed as elemental iron
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Feraheme: 510 mg/17 mL (17 mL)
Generic: 510 mg/17 mL (17 mL)
Yes
Solution (Feraheme Intravenous)
510 mg/17 mL (per mL): $81.80
Solution (Ferumoxytol Intravenous)
510 mg/17 mL (per mL): $63.91
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer each 510 mg dose diluted as a slow IV infusion over at least 15 minutes. When administering as a single dose (ie, 1.02 g), administer over ~30 minutes (Ref). Patient should be in a reclined or semi-reclined position during the infusion; monitor for signs of hypersensitivity (including BP and pulse) for at least 30 minutes after infusion. Also refer to institution-specific protocols. Note: Serious hypersensitivity reactions have been observed with rapid IV injection (<1 minute) (Ref). Wait ≥30 minutes between administration of ferumoxytol and other agents that may cause serious hypersensitivity reactions and/or hypotension (eg, chemotherapy, monoclonal antibodies).
Hemodialysis patients: Administer dose after at least 1 hour of hemodialysis has been completed and once BP has stabilized.
Parenteral: IV: Magnetic resonance imaging: Administration practice may vary with type of imaging being performed (Ref). In adults, serious hypersensitivity reactions have been observed with rapid IV injection (<1 minute) (Ref); consider waiting ≥30 minutes between administration of ferumoxytol and other agents that may cause serious hypersensitivity reactions and/or hypotension (eg, chemotherapy, monoclonal antibodies).
Neonates: Administration as a diluted solution IV over 5 to 15 minutes has been reported (Ref).
Infants, Children, and Adolescents: Administer as a diluted solution over ≥15 minutes (Ref). In a cardiac MRI trial (n=61) performed under general anesthesia, ferumoxytol was infused over 5 to 15 minutes (Ref).
Iron-deficiency anemia: Treatment of iron-deficiency anemia in adults with an intolerance or unsatisfactory response to oral iron or who have chronic kidney disease
Magnetic resonance imaging
Ferumoxytol may be confused with ferric carboxymaltose, ferric gluconate, iron dextran complex, iron sucrose
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: Avoid combination
Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
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]).
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 [Siu 2015]). 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]).
Ferumoxytol has been evaluated in pregnant patients with IDA (Gerb 2021; Karki 2019). Due to limited safety data in early pregnancy, use of IV iron is generally not started until the second or third trimester (ACOG 2021; BSH [Pavord 2020]; FIGO 2019).
Ferumoxytol has been evaluated for use as an alternative to gadolinium-based contrast agents in patients undergoing an MRI; this use is not currently recommended in pregnant patients (ACOG 2017; Little 2020).
Iron 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).
Iron deficiency and IDA are associated with adverse effects in postpartum patients (eg, altered cognition, depression, fatigue), which 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 benefits of treatment to the mother.
Hemoglobin, serum ferritin, serum iron, transferrin saturation (at least 1 month following second injection and periodically); signs/symptoms of hypersensitivity reactions, blood pressure, pulse (during and ≥30 minutes following administration)
Anemia:
Hemoglobin, whole blood:
Female: 12 to16 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 (ABIM 2023):
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 (Gutiérrez 2021; KDIGO 2012).
Superparamagnetic iron oxide coated with a low molecular weight semisynthetic carbohydrate; iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen, and bone marrow where the iron is released from the complex. The released iron is either transported into storage pools or is transported via plasma transferrin for incorporation into hemoglobin.
Distribution: Vd: 3.16 L
Metabolism: Iron released from iron-carbohydrate complex after uptake in the reticuloendothelial system macrophages of the liver, spleen, and bone marrow
Half-life elimination: ~15 hours
Dialysis: Ferumoxytol is not removed by hemodialysis
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