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Ferumoxytol

Pronunciation

(fer ue MOX i tol)

Dosage Forms

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

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Solution, Intravenous [preservative free]:

Feraheme: 510 mg/17 mL (17 mL)

Brand Names: U.S.

  • Feraheme

Pharmacologic Category

  • Iron Salt

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 in chronic kidney disease: Treatment of iron-deficiency anemia in adults with chronic kidney disease

Contraindications

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

Canadian labeling: Additional contraindications (not in US labeling): Any known history of drug allergy, evidence of iron overload; anemia not caused by iron deficiency

Dosage

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

Iron-deficiency anemia in chronic kidney disease: Adults: IV:

US labeling: 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.

Canadian labeling:

Baseline hemoglobin >10 to 12 g/dL:

Body weight ≤50 kg: 510 mg as an IV infusion.

Body weight >50 kg: 510 mg as an IV infusion, followed by a second 510 mg IV infusion 2 to 8 days after initial dose.

Baseline hemoglobin ≤10 g/dL (regardless of weight): 510 mg as an IV infusion, followed by a second 510 mg IV infusion 2 to 8 days after initial dose.

Dosage adjustment in renal impairment: 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.

Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

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 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.

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.

Drug Interactions

Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. 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

1% to 10%:

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

Central nervous system: Dizziness (3%), headache (2%), fever (1%)

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

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

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

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

Miscellaneous: Hypersensitivity reactions (≤4%; serious reactions: <1%)

<1% (Limited to important or life-threatening): Anaphylactic/anaphylactoid reactions, angioedema, cardiac/cardiorespiratory arrest, cardiac rhythm abnormalities, congestive heart failure, cyanosis, fatigue, hypotension (clinically significant); infusion site reactions (including bruising, burning, erythema, irritation, pain, swelling, warmth); ischemic myocardial events, loss of consciousness, pulse absent, syncope, tachycardia, unresponsiveness, 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 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, including anaphylactic-type reactions (some fatal), may occur, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness even in patients who previously tolerated ferumoxytol. Equipment for resuscitation and trained personnel experienced in handling emergencies should be 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.

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 Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. The Canadian labeling recommends avoiding use in women of childbearing potential not using adequate contraception.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, nausea, or constipation. Have patient report immediately to prescriber signs of infusion reaction (bluish skin or nails; chest, jaw, or left arm pain; rash; angioedema; dizziness or passing out; difficulty breathing; wheezing) or swelling of arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating and advising patients.

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