Ferumoxytol Solution for injection

What is this medicine?

FERUMOXYTOL is an iron complex. Iron is used to make healthy red blood cells, which carry oxygen and nutrients throughout the body. This medicine is used to treat iron deficiency anemia in people with chronic kidney disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• anemia not caused by low iron levels

• high levels of iron in the blood

• magnetic resonance imaging (MRI) test scheduled

• an unusual or allergic reaction to iron, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

This medicine may interact with the following medications:

• other iron products

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or healthcare professional regularly. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medicine.

You may need to follow a special diet. Talk to your doctor. Foods that contain iron include: whole grains/cereals, dried fruits, beans, or peas, leafy green vegetables, and organ meats (liver, kidney).

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in blood pressure

• feeling faint or lightheaded, falls

• fever or chills

• flushing, sweating, or hot feelings

• swelling of the ankles or feet

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• headache

• nausea, vomiting

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

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

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.