Class: Iron Preparations
VA Class: TN410
Molecular Formula: Fe5874O8752C11719H18682O9933Na414
CAS Number: 1309-38-2
- Serious Hypersensitivity Reactions/Anaphylaxis
Serious, sometimes fatal, hypersensitivity reactions including anaphylaxis have occurred. Initial manifestations may include hypotension, syncope, unresponsiveness, or cardiac/cardiorespiratory arrest.
Only administer ferumoxytol in settings where appropriate medical support is available for management of anaphylaxis and other hypersensitivity reactions.
Observe closely for hypersensitivity reactions during and for at least 30 minutes after completion of each infusion; monitor BP and heart rate before and after administration.
Hypersensitivity reactions have occurred in patients who have previously tolerated the drug.
Hematinic agent: a superparamagnetic iron oxide nanoparticle with a polyglucose sorbitol carboxymethylether coating.
Uses for Ferumoxytol
Iron Deficiency Anemia in Patients with Chronic Kidney Disease
Treatment of iron deficiency anemia in adults with chronic kidney disease (CKD).
National Kidney Foundation guidelines recommend use of IV iron in patients undergoing hemodialysis and either oral or IV iron in patients undergoing peritoneal dialysis and in those with chronic kidney disease not on dialysis.
Ferumoxytol Dosage and Administration
Goal of iron therapy in patients with chronic renal failure not undergoing dialysis or undergoing peritoneal dialysis is to achieve and maintain a transferrin saturation (TSAT) of >20% and a serum ferritin concentration of >100 ng/mL.
Goal of iron therapy in patients with chronic renal failure undergoing hemodialysis is to achieve and maintain a TSAT of >20% (or content of hemoglobulin in reticulocytes [CHr] >29 pg/cell) and a serum ferritin concentration of >200 ng/mL.
Evaluate hematologic response (e.g., serum ferritin concentration, hemoglobin level, iron and transferrin saturation) at least one month after the second dose of ferumoxytol.
Monitor closely for hypersensitivity reactions, including monitoring of BP and heart rate during and for at least 30 minutes after each infusion until clinically stable. Ensure that appropriate agents and personnel for the treatment of anaphylaxis and hypersensitivity reactions are readily available.
Administer by IV infusion.
Hemodialysis patients: Administer after first hour of dialysis, once patient is hemodynamically stable.
Administer while the patient is in a reclining or semi-reclining position.
Allow at least 30 minutes to elapse between administration of ferumoxytol and other drugs that could potentially cause serious hypersensitivity and/or hypotensive reactions (e.g., antineoplastic agents, monoclonal antibodies).
Dilute in 50–200 mL of 0.9% sodium chloride or 5% dextrose injection; do not administer undiluted.
Rate of Administration
Administer over ≥15 minutes.
Dosage expressed in terms of mg of elemental iron. Ferumoxytol injection contains the equivalent of 30 mg of elemental iron per mL.
Iron Deficiency Anemia in Patients with Chronic Kidney Disease
Initially, 510 mg as single infusion; repeat 510-mg dose 3–8 days after initial dose.
May repeat recommended dosage for persistent or recurrent iron deficiency anemia.
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
Cautions for Ferumoxytol
Known hypersensitivity to ferumoxytol or any ingredient in the formulation.
History of allergic reaction to any IV iron preparation.
Serious, sometimes fatal, hypersensitivity reactions, including anaphylaxis associated with cardiac/cardiorespiratory arrest, clinically important hypotension, syncope, or unresponsiveness, reported. Serious hypersensitivity reactions reported in 0.2% of patients; other potential hypersensitivity reactions (e.g., pruritus, rash, urticaria, wheezing) reported in 3.7% of patients.
Hypersensitivity reactions may occur after the first dose or subsequent doses and also in patients who have previously tolerated the drug. Possible increased risk of hypersensitivity reaction to parenteral iron preparations in patients with history of multiple drug allergies; carefully consider potential risks and benefits of the drug in such patients. Do not administer to patients with a history of allergic reactions to IV iron preparations. (See Contraindications.)
Administer IV iron preparations only to patients who require IV iron therapy. Monitor patient for hypersensitivity reactions during and for at least 30 minutes after each infusion. Ensure ready availability of appropriate agents and personnel for the treatment of hypersensitivity reactions. (See General and also Administration under Dosage and Administration.)
Other Warnings and Precautions
Hypotension reported in 1.9% of patients in clinical trials, including serious hypotensive reactions in a few patients. Monitor patients for signs and symptoms of hypotension.
Do not administer ferumoxytol to patients with iron overload. Excessive administration of parenteral iron preparations may cause excess storage of iron with the possibility of iatrogenic hemosiderosis.
Evaluate hematologic response at least 1 month after second dose. Laboratory assays may overestimate serum iron and transferrin-bound iron in the 24 hours following infusion of ferumoxytol.
Alteration of Magnetic Resonance Imaging (MRI) Studies
May temporarily affect MRI studies; alteration in MRI studies may persist for up to 3 months after the last dose of ferumoxytol.
Schedule MRI studies before administration of ferumoxytol. If MRI studies are needed within 3 months of ferumoxytol administration, use of T1- or proton density-weighted pulse sequences minimizes the effects of the drug. Do not perform MRI studies using T2-weighted pulse sequences earlier than 4 weeks after drug administration. Maximum alteration in vascular MRI studies is expected for 1–2 days following drug administration.
Does not interfere with radiography, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound, or nuclear imaging.
Not know whether ferumoxytol is distributed into human milk. Discontinue nursing or the drug, taking into account the importance of the drug to the woman and the benefits of nursing.
Safety and efficacy not established in pediatric patients.
No overall differences in efficacy or safety relative to younger adults; possibility of increased sensitivity cannot be ruled out. Use caution in dosage selection. (See Geriatric Patients under Dosage and Administration.)
Outcomes of hypersensitivity and/or hypotensive reactions to ferumoxytol may be more severe in geriatric patients with multiple or serious comorbidities; carefully consider potential risks and benefits of the drug in such patients.
Common Adverse Effects
Diarrhea, nausea, dizziness, hypotension, constipation, peripheral edema.
Interactions for Ferumoxytol
No formal drug interaction studies to date.
Oral Iron Preparations
Ferumoxytol expected to reduce absorption of concomitantly administered oral iron.
Time to peak plasma concentrations is 0.32 hours.
Not removed by dialysis.
20–25°C (may be exposed to 15–30°C).
Following dilution, use immediately or store at 25°C; discard after 4 hours.
For information on systemic interactions resulting from concomitant use, see Interactions.
Sodium chloride 0.9%
Dextrose 5% in water
Ferumoxytol is taken up by the reticuloendothelial system. Subsequently, iron is released from ferumoxytol into macrophages. Iron enters the intracellular storage pool or is bound to plasma transferrin for transport to erythroid precursor cells where it is incorporated into hemoglobin.
Advice to Patients
Risk of serious hypersensitivity reactions. Importance of patient informing clinician of prior hypersensitivity reactions to parenteral iron preparations or other drugs. Importance of patient alerting clinician or seeking immediate medical attention if any symptoms of allergic reaction occur during or after infusion of the drug (e.g., rash, itching, dizziness, lightheadedness, swelling of the tongue or throat, wheezing, breathing difficulty).
Risk of hypotension.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or conditions (e.g., hypotension, multiple drug allergies).
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Injection, for IV use
equivalent to 30 mg of elemental iron per mL
AHFS DI Essentials™. © Copyright 2021, Selected Revisions November 13, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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