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Ferumoxytol

Medically reviewed by Drugs.com. Last updated on June 24, 2020.

Pronunciation

(fer ue MOX i tol)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Feraheme: 510 mg/17 mL (17 mL)

Brand Names: U.S.

  • Feraheme

Pharmacologic Category

  • Iron Preparations

Pharmacology

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; ferumoxytol is not removed by hemodialysis

Use: Labeled Indications

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

Contraindications

Hypersensitivity to ferumoxytol, other IV iron products, or any component of the formulation

Dosing: Adult

Doses expressed in mg of elemental iron. Note: Test dose: Product labeling does not indicate need for a test dose.

Iron-deficiency anemia: IV:

Two-dose regimen: 510 mg over at least 15 minutes; after 3 to 8 days has elapsed, repeat dose. Assess response at least 30 days following the second dose. May readminister regimen in patients with persistent or recurrent iron-deficiency anemia.

Single-dose regimen: 1.02 g over ~30 minutes as a single dose (Auerbach 2013; Karki 2019).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Must be diluted prior to administration. To prepare for intravenous infusion, dilute in 50 to 200 mL of NS or D5W.

Administration

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 (Auerbach 2013; Karki 2019). 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. Note: Serious hypersensitivity reactions have been observed with rapid IV injection (<1 minute) (Macdougall 2014; Vadhan-Raj 2014). 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.

Storage

Store intact vials at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Solutions diluted in NS or D5W at concentrations of 2 to 8 mg/mL elemental iron should be used immediately, but may be stored at 23°C to 27°C (73°F to 81°F) for up to 4 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 48 hours. Discard unused portion.

Drug Interactions

Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Avoid combination

Test Interactions

May interfere with MR imaging; alterations may persist for ≤3 months following use, with peak alterations anticipated in the first 2 days following administration. If MR imaging is required within 3 months after administration, use T1- or proton density-weighted MR pulse sequences to decrease effect on imaging. Do not use T2-weighted sequence MR imaging prior to 4 weeks following administration.

Serum iron and transferrin-bound iron may be overestimated in laboratory assays if level is drawn during the first 24 hours following administration (due to contribution of iron in ferumoxytol).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Hypotension (≤3%), edema (2%), peripheral edema (2%), chest pain (1%), hypertension (1%)

Central nervous system: Dizziness (2% to 3%), headache (2% to 3%), fatigue (2%)

Dermatologic: Pruritus (1%), skin rash (1%)

Gastrointestinal: Diarrhea (1% to 4%), nausea (2% to 3%), constipation (2%), vomiting (2%), abdominal pain (1%)

Hypersensitivity: Hypersensitivity reaction (≤4%; serious hypersensitivity: <1%)

Neuromuscular & skeletal: Back pain (1%), muscle spasm (1%)

Respiratory: Cough (1%), dyspnea (1%)

Miscellaneous: Fever (1%)

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, cardiac arrhythmia, cardiac failure, cyanosis, ischemic heart disease, loss of consciousness, syncope, tachycardia, unresponsive to stimuli, urticaria, wheezing

ALERT: U.S. Boxed Warning

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.

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.

Warnings/Precautions

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 (MR) imaging: Administration may alter MR imaging; conduct anticipated MRI studies prior to use. MR imaging alterations may persist for ≤3 months following use, with peak alterations anticipated in the first 2 days following administration. If MR imaging is required within 3 months after administration, use T1- or proton density-weighted MR pulse sequences to decrease effect on imaging. Do not use T2-weighted sequence MR imaging 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.

Monitoring Parameters

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)

Pregnancy Considerations

Maternal iron requirements increase during pregnancy. Adequate iron concentrations to the fetus can be maintained regardless of maternal iron status, except in severe cases of anemia (IOM 2001). Untreated iron deficiency and iron deficiency anemia (IDA) in a pregnant female may be associated with adverse events, including low birth weight, preterm birth, or increased perinatal mortality (ACOG 95 2008; BSH [Pavord 2020]; IOM 2001).

In general, treatment of iron deficiency or IDA in pregnancy is the same as in nonpregnant females (USPSTF [Siu 2015]). The majority of studies note iron therapy improves maternal hematologic parameters; however, information related to clinical outcomes in the mother and neonate is limited (FIGO 2019; USPSTF [Siu 2015]). Oral preparations are generally sufficient; however, parenteral iron therapy may be used in females who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008; BSH [Pavord 2020]). Due to limited safety data in early pregnancy, use of IV iron products is generally not started until the second or third trimester (BSH [Pavord 2020]; FIGO 2019).

Patient Education

What is this drug used for?

• It is used to treat anemia.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea

• Headache

• Nausea

• Constipation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infusion reaction like chest, jaw, or left arm pain; abnormal heartbeat; itching; rash; swelling in your throat; dizziness or passing out; trouble breathing; or wheezing

• Swelling of arms or legs

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.