Ferabright (ferumoxytol)

The dosage of ferumoxytol is expressed in terms of mg of elemental iron. Ferumoxytol injection contains the equivalent of 30 mg of elemental iron per mL.

For the treatment of iron deficiency in adults with chronic kidney disease, the recommended initial dose of ferumoxytol is 510 mg administered by IV infusion; a second dose of 510 mg is administered by IV infusion 3-8 days after the initial dose.

Hematologic response should be evaluated at least 1 month following the second dose of ferumoxytol. (See Iron Overload under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) For patients with persistent or recurrent iron deficiency anemia, the recommended dosage of ferumoxytol may be repeated.

Ferumoxytol is administered by IV infusion over at least 15 minutes; the infusion should be administered while the patient is in a reclining or semi-reclining position. Prior to administration, the drug must be diluted in 50-200 mL of 0.9% sodium chloride or 5% dextrose injection; ferumoxytol should not be administered undiluted.

When added to an infusion bag containing 0.9% sodium chloride or 5% dextrose injection, ferumoxytol solutions containing 2-8 mg/mL of elemental iron should be used immediately but may be stored at a controlled room temperature of 25degreesC for up to 4 hours. The IV solution should be inspected visually for particulate matter and discoloration prior to administration.

In patients undergoing hemodialysis, ferumoxytol should be administered at any time after the first hour of the hemodialysis session, once hemodynamic stabilization has been achieved.

Ferumoxytol should be administered only in settings where appropriate medical support is available for management of anaphylaxis and other hypersensitivity reactions. Patients receiving the drug should be closely monitored for hypersensitivity reactions, including monitoring of blood pressure and heart rate during and for at least 30 minutes after each ferumoxytol infusion and until clinically stable. (See Sensitivity Reactions under Cautions: Warnings/Precautions and also see Hypotension under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

At least 30 minutes should elapse between administration of ferumoxytol and other drugs that could potentially cause serious hypersensitivity and/or hypotensive reactions (e.g., antineoplastic agents, monoclonal antibodies).

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to ferumoxytol or any ingredient in the formulation.

History of allergic reaction to any IV iron preparation.

• Hemosiderosis

• Chronic iron overload

• Hypotension
• Magnetic resonance imaging

Adverse effects reported in 2% or more of patients receiving ferumoxytol include diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.

More Frequent

• Hypotension

Less Frequent

• Chest pain
• Hypersensitivity drug reaction

Rare or Very Rare

• Acute myocardial infarction
• Anaphylaxis
• Angioedema
• Cardiac arrest
• Chronic heart failure
• Cyanosis
• Dyspnea
• Hemosiderosis
• Myocardial ischemia
• Severe hypotension
• Syncope
• Thrombotic disorder
• Unconsciousness

More Frequent

• Constipation
• Diarrhea
• Dizziness
• Fatigue
• Headache disorder
• Nausea
• Peripheral edema

Less Frequent

• Acute abdominal pain
• Back pain
• Cough
• Ecchymosis
• Fever
• Hypertension
• Injection site sequelae
• Muscle spasm
• Pruritus of skin
• Skin rash
• Vomiting

Rare or Very Rare

• Tachycardia
• Urticaria

No enhanced messaging available.

Safety and efficacy not established in pediatric patients.

Category C. (See Users Guide)

Not know whether ferumoxytol is distributed into human milk. A decision should be make whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman and the benefits of nursing.

Although no overall differences in efficacy or safety were observed between geriatric and younger adults receiving ferumoxytol, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out. Caution is advised when selecting the dosage. (See Dosage and Administration: Special Populations.)

Geriatric patients with multiple or serious comorbidities who experience a hypersensitivity reaction and/or hypotension following ferumoxytol administration may have more severe outcomes; the potential risks and benefits of the drug should be considered carefully in such patients.