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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Feraheme: 510 mg/17 mL (17 mL)
Mechanism of Action
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.
Vd: 3.16 L
Iron released from iron-carbohydrate complex after uptake in the reticuloendothelial system macrophages of the liver, spleen, and bone marrow
~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
Hypersensitivity to ferumoxytol, other IV iron products, or any component of the formulation
Dosage and Administration
Doses expressed in mg of elemental iron. Note: Test dose: Product labeling does not indicate need for a test dose.
Iron-deficiency anemia: IV: 510 mg as an IV infusion, followed by a second 510 mg IV infusion 3 to 8 days after initial dose. Assess response at least 30 days following the second dose. The recommended dose may be readministered in patients with persistent or recurrent iron-deficiency anemia.
Refer to adult dosing.
Must be diluted prior to administration. To prepare for intravenous infusion, dilute in 50 to 200 mL of NS or D5W.
IV: Administer diluted as a slow IV infusion over at least 15 minutes. Patient should be in a reclined or semi-reclined position during the infusion; monitor for signs of hypersensitivity (including blood pressure 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 blood pressure has stabilized.
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.
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Avoid combination
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).
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
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.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
- 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.
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)
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; IOM 2001; Pavord 2012).
In general, treatment of iron deficiency or IDA in pregnancy is the same as in non-pregnant females. The majority of studies note iron therapy improves maternal hematologic parameters; however, information related to clinical outcomes in the mother and neonate is limited (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; Pavord 2012). Due to limited safety data in early pregnancy, use of intravenous iron products is generally not started until the second or third trimester (Breymann 2017; Pavord 2012).
What is this drug used for?
- It is used to treat anemia.
Frequently reported side effects of this drug
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- 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 a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.