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Ferumoxytol

Also known as: Ferumoxytol

Parenteral Iron Replacement

Route: Intravenous

1 interaction on record⛔ Black Box Warning

Ferumoxytol has 1 known drug interaction based on U.S. FDA drug labeling data. Notable interactions include combinations with Oral Iron Preparations. Patients taking Ferumoxytol should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 1
Moderate: 1

Moderate (1)

Ferumoxytol + Oral Iron Preparations— Ferumoxytol may reduce the absorption of concomitantly administered oral iron preparations.

Ferumoxytol + Oral Iron Preparations🟡Moderate

Ferumoxytol may reduce the absorption of concomitantly administered oral iron preparations.

⛔ FDA Black Box Warning

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS 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 [see Warnings and Precautions ( 5.1 ) ]. • 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 ferumoxytol administration [see Warnings and Precautions ( 5.1 ) ]. • Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated [see Warnings and Precautions ( 5.1 ) ] . WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS See full prescribing information for complete boxed warning. 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. ( 5.1 ) • 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 ferumoxytol administration. ( 5.1 ) • Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated. ( 5.1 )

Contraindications

4 CONTRAINDICATIONS Ferumoxytol is contraindicated in patients with: • Known hypersensitivity to ferumoxytol or any of its components [see Warnings and Precautions ( 5.1 )] . • History of allergic reaction to any intravenous iron product [see Warnings and Precautions ( 5.1 )] . • Known hypersensitivity to ferumoxytol or any of its components. ( 4 ) • History of allergic reaction to any intravenous iron product. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. 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 ). In animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as ferumoxytol) which may cause fetal bradycardia, especially during the second and third trimester. Data Animal Data Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects. These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxy

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.