Ferumoxytol

Ferumoxytol is an iron replacement product used in adults to treat iron deficiency anemia (IDA), which occurs when there are low red blood cells due to insufficient iron in the body.

Ferumoxytol is administered to adults with IDA and chronic kidney disease, or to adults with IDA when oral iron is not effective.

Ferumoxytol may also be used for reasons not mentioned in this medication guide.

Ferumoxytol is injected into a vein by a healthcare provider.

This medicine must be given slowly over 15 minutes.

You will be watched for at least 30 minutes to make sure you do not have an allergic reaction.

Ferumoxytol is usually given in 2 doses, 3 to 8 days apart.

You may need frequent medical tests, even if you have no symptoms.

Ferumoxytol can affect the results of an MRI (magnetic resonance imaging) for up to 3 months after you receive this medicine. Tell any doctor who treats you that you have received a ferumoxytol injection.

Ferumoxytol will not affect other types of X-rays, CT scans, ultrasounds, or nuclear radiation imaging.

Ferumoxytol can cause serious or life-threatening allergic reactions, even if you have taken this medicine before without any issues. Seek emergency medical help if you experience hives, itching, wheezing, difficulty breathing, swelling in your face or throat, or if you feel faint. Monitor for signs of an allergic reaction for at least 30 minutes after your injection.

You should not use ferumoxytol if you are allergic to it, or if:

• you've had an allergic reaction to iron injected into a vein.

Tell your doctor if you have ever had:

• iron overload syndrome;
• any drug allergies; or
• low blood pressure.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if ferumoxytol will harm an unborn baby, but ferumoxytol may cause severe reactions in the mother that could affect the baby's heartbeat.

Having iron deficiency anemia during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating this condition with ferumoxytol may outweigh any risks to the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult breathing; a light-headed feeling (like you might pass out); swelling of your face, lips, tongue, or throat.

Ferumoxytol can cause severe or fatal allergic reactions, even if you have used ferumoxytol before without any reaction. Watch for signs of allergic reaction for at least 30 minutes after your injection.

Ferumoxytol may cause serious side effects. Call your doctor right away if you have:

• a light-headed feeling, like you might pass out;
• severe or ongoing vomiting or diarrhea;
• a seizure;
• kidney problems—swelling, urinating less, feeling tired or short of breath; or
• heart problems—chest pain, fast or pounding heartbeats, rapid weight gain, feeling short of breath.

Common side effects of ferumoxytol may include:

• headache, dizziness;
• diarrhea, constipation;
• nausea; or
• swelling in your arms, hands, legs, or feet.

Usual Adult Dose for Iron Deficiency Anemia:

Initial dose: 510 mg, IV, over at least 15 minutes Second dose: 510 mg, IV, over at least 15 minutes, 3 to 8 days after the initial doseComments:-The patient should be reclined or semi-reclined during administration.-Evaluate hematologic response at least one month after the second infusion.-May be readministered for persistent or recurrent iron deficiency anemia.Use: Iron deficiency anemia in adult patients with chronic kidney disease.

Call your doctor for guidance if you miss an appointment for your ferumoxytol injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take iron supplements or a vitamin/mineral supplement that your doctor has not prescribed or recommended.

Ferumoxytol can make it more difficult for your body to absorb iron medicines that you take by mouth.

Other drugs may influence how ferumoxytol works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.