Commonly Used Brand Name(s)Feraheme
Therapeutic ClassificationsParenteral Mineral-Trace Mineral
QUICK LINKS
- Blackbox Warning
- Overview
- Proper Use
- Before Using
- Allergies
- Pediatric
- Geriatric
- Pregnancy
- Breast Feeding
- Drug Interactions
- Other Interactions
- Other Medical Problems
- Precautions
Blackbox WarningTOP
Fatal and serious hypersensitivity reactions, including anaphylaxis, have been reported with ferumoxytol and have occurred in patients who previously tolerated the drug. Symptoms may include hypotension, syncope, unresponsiveness, and cardiac or cardiorespiratory arrest. Administer ferumoxytol in a setting where personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe patients during and for at least 30 minutes following the infusion for signs and symptoms of hypersensitivity reactions, including monitoring of blood pressure and pulse .
OverviewTOP
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 to be given only by or under the direct supervision of your doctor.
Proper UseTOP
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.
This medicine comes with a patient package insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Before UsingTOP
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:
AllergiesTOP
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.
PediatricTOP
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.
GeriatricTOP
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.
PregnancyTOP
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal 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 FeedingTOP
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.
Drug InteractionsTOP
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 InteractionsTOP
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 ProblemsTOP
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.
PrecautionsTOP
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 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 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 (eg, magnetic resonance imaging or MRI) may be affected by this medicine.
