Pronunciation:

fer-ue-MOX-i-tol

Brand Names:

• Feraheme

Dosage Forms:

• Solution

Warnings:

Risk For Serious Hypersensitivity/Anaphylaxis ReactionsFatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, and cardiac or 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 ferumoxytol administration.Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated .

Classifications:

Therapeutic—

Parenteral Mineral-Trace Mineral

Uses of This Medicine:

Ferumoxytol injection is an iron replacement product that is used to treat iron deficiency anemia (not enough iron in the blood) in patients with chronic kidney disease (CKD) and in patients unable to take oral iron or who had taken oral iron in the past but did not work well.

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ferumoxytol injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ferumoxytol injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving ferumoxytol injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

• Iron overload—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to stay in place for at least 15 minutes. Your doctor may need you to stay for at least 30 minutes after receiving the medicine to check for unwanted effects. A second dose will be given 3 to 8 days after your first dose.

This medicine comes with a patient information leaflet. Read and understand the instructions carefully. Ask your doctor if you have questions.

If you are also using cancer medicines, take them at least 30 minutes after receiving this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin receiving this medicine or when the dose is increased.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests (eg, magnetic resonance imaging or MRI) may be affected by this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

chest pain

confusion

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever

rapid weight gain

sweating

tightness in the chest

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Bluish color of the fingernails, lips, skin, palms, or nail beds

chest discomfort

cough

decreased urine output

difficulty with swallowing

dilated neck veins

dizziness

extreme tiredness or weakness

fainting

fast, pounding, or irregular heartbeat or pulse

hives, itching, or skin rash

irregular breathing

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of consciousness

nausea

no blood pressure or pulse

pain in the shoulders, arms, jaw, or neck

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stopping of the heart

unconsciousness

unresponsiveness

vomiting

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

headache

muscle spasms

stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.