Ferumoxytol Injection

IMPORTANT WARNING:

Ferumoxytol injection may cause severe or life-threatening reactions during and after you receive the medication. Your doctor will watch you carefully while you receive each dose of ferumoxytol injection and for at least 30 minutes afterward. Tell your doctor if you experience any of the following symptoms during or after your injection: shortness of breath; wheezing; difficulty swallowing or breathing; hoarseness; swelling of the face, throat, tongue, lips, or eyes; hives; rash; itching; fainting; lightheadedness; dizziness; or loss of consciousness. If you experience a severe reaction, your doctor will stop your infusion immediately and provide emergency medical treatment.

WHY is this medicine prescribed?

Ferumoxytol injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working). Ferumoxytol injection is used to treat iron-deficiency anemia in people who did not respond or are unable to tolerate taking iron preparations by mouth. Ferumoxytol injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ferumoxytol injection comes as a solution (liquid) to inject intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic. It is usually injected slowly over at least 15 minutes. Ferumoxytol injection is usually given as a total of two doses, spaced 3 to 8 days apart. If your iron levels become or remain low after you finish your treatment, your doctor may prescribe this medication again.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ferumoxytol injection,

• tell your doctor and pharmacist if you are allergic to ferumoxytol injection; any other iron injection such as iron dextran (Dexferrum, InFed, Proferdex), iron sucrose (Venofer), or sodium ferric gluconate (Ferrlecit); any other medications; or any of the ingredients in ferumoxytol injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention iron supplements that are taken by mouth. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had any medical condition.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving ferumoxytol injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive ferumoxytol injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Ferumoxytol injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• nausea
• vomiting
• stomach pain
• headache
• swelling of the hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience the following symptom or those symptoms listed in the IMPORTANT WARNINGS section, call your doctor immediately or get emergency medical treatment:

• chest pain

Ferumoxytol injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure and order certain lab tests to check your body's response to ferumoxytol injection.

Before having any magnetic resonance imaging (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body), tell your doctor and the testing personnel that you are receiving ferumoxytol injection. Ferumoxytol injection may affect MRI studies for up to 3 months after your last dose of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.