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Ferumoxytol (Intravenous route)

Pronunciation:

fer-ue-MOX-i-tol

Brand Names:

  • Feraheme

Dosage Forms:

  • Solution

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).

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 available only with your doctor's prescription.

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 in one of your veins. A second dose will be given 3 to 8 days after your first dose.

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. Anaphylaxis 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 with breathing; trouble with 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 from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin using 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 (e.g., 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
shortness of breath
sweating
tightness in the chest
tingling of the hands or feet
unusual tiredness or weakness
unusual weight gain or loss
wheezing
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 fatigue
fainting
fast, pounding, or irregular heartbeat or pulse
hives
irregular breathing
itching
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of consciousness
nausea or vomiting
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
skin rash
stopping of the heart
swelling of the face, fingers, feet, or lower legs
troubled breathing
unconsciousness
unresponsiveness
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
Abdominal or stomach pain
back pain
headache
muscle spasms

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.


Last Updated: 11/4/2014

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