Ferumoxytol

Black Box Warnings

Initial symptoms of hypersensitivity may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred

Initial symptoms may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest

Only administer 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 infusion, including monitoring of blood pressure and pulse during and after administration

Hypersensitivity reactions have occurred in patients in whom a previous dose was tolerated

Contraindications

Known hypersensitivity to ferumoxytol or any of its components

History of allergic reaction to any intravenous iron product

Cautions

May cause life-threatening hypersensitivity reactions such as anaphylaxis and/or anaphylactoid reactions (see Black Box Warnings)

Observe for signs and symptoms of hypersensitivity for at least 30 minutes following administration; elderly patients (> 65 years of age) or patients with multiple comorbidities who experience a serious hypersensitivity reaction due to ferumoxytol may have more severe outcomes

Risk of anaphylaxis increases in patients with multiple drug allergies

Anaphylactic reactions presenting with cardiac/cardiorespiratory arrest, syncope, hypotension and unresponsiveness have been identified in post-marketing reports

May cause severe adverse reactions of clinically significant hypotension (monitor blood pressure during/following administration)

Monitor hematologic responses during therapy, do not administer if evidence of iron overload

Can alter magnetic resonance imaging (MRI) studies

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Do not take any vitamin or mineral supplements that your doctor has not prescribed or recommended.

• If you have an allergy to ferumoxytol or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Anemia from a cause other than low iron stores or too much iron in your body.

This is not a list of all drugs or health problems that interact with ferumoxytol.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Feraheme

• Iron Salt

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: 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.

Data not available