ferumoxytol 510 mg/17 mL (30 mg/mL) intravenous solution

Generic name:
Ferumoxytol - injection

Pronunciation
(FER-ue-MOX-i-tol)

Brand name(s)
Feraheme

Rarely, some people using this medication have had a serious allergic reaction, even if they did not have a reaction in the past. You will need to stay in a clinic or hospital during and for at least 30 minutes after your injection so your doctor can monitor you closely and check your blood pressure and pulse. Get medical help right away if you develop symptoms such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, fainting, trouble breathing.

This medication is used to treat "iron-poor" blood (iron deficiency anemia). Ferumoxytol is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. It is also used by people who have anemia due to long-term kidney disease.

Iron is an important part of your red blood cells and is needed to carry oxygen throughout the body. Many people with kidney disease cannot get enough iron from food and require injections. People with kidney disease may also need extra iron because of blood loss during kidney dialysis treatment.

Read the Patient Information Leaflet if available from your pharmacist before you start using ferumoxytol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Ferumoxytol is given by a health care professional. It is given by slow injection into a vein over at least 15 minutes, usually in a clinic or hospital. Treatment involves receiving two doses of ferumoxytol, given 3 to 8 days apart. It may be given during dialysis.

The dosage is based on your medical condition and response to treatment. Your doctor will take blood tests to monitor your response to treatment.

See also Warning section.

Dizziness or fainting (hypotension) may occur. Pain, swelling, or redness at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness or fainting, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• unusual bruising
• darkening of skin (bronze tone)
• swelling of hands/feet/lower legs
• chest pain

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

During use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI scan.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults that have a serious allergic reaction or dizziness while using this drug may have more severe symptoms.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other iron products

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, iron level, blood pressure, pulse) should be done while you are using this medication. Keep all medical and lab appointments.

It is important to eat a well-balanced diet to get enough iron, vitamins, and minerals. Good sources of iron include meats (especially liver), eggs, raisins, figs, broccoli, brussels sprouts, beans, lentils, and iron-fortified or enriched cereals. Follow diet recommendations for your condition.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.