Ferric carboxymaltose injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults and children 1 year of age and older who cannot tolerate or who could not successfully be treated with iron supplements taken by mouth. This medication is also used to treat iron deficiency anemia in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working) who are not on dialysis. Ferric carboxymaltose injection is also used to treat iron-deficiency anemia and improve the ability to exercise in certain adults with congestive heart failure (a condition when your heart cannot pump enough blood to the other parts of the body). Ferric carboxymaltose 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.

Ferric carboxymaltose 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. For the treatment of iron-deficiency anemia in patients who could not tolerate or be treated with oral supplements or who have chronic kidney disease, it is usually given as a total of 2 doses, spaced at least 7 days apart. It may also be given as a single dose in adults. For the treatment of iron-deficiency anemia and to improve the ability to exercise in adults with congestive heart failure, it is usually given once every 6 weeks for no more than a total of 5 doses. If your iron levels become low after you finish your treatment, your doctor may prescribe this medication again.

Ferric carboxymaltose injection may cause severe or life-threatening reactions during and shortly after you receive the medication. Your doctor will watch you carefully while you receive each dose of ferric carboxymaltose injection and for at least 30 minutes afterwards. Your doctor will also check your blood pressure frequently during this time. 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; flushing of the face; nausea; cold, clammy skin; rapid, weak pulse; chest pain; or loss of consciousness. If you experience a severe reaction, your doctor will stop your infusion immediately and provide emergency medical treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before receiving ferric carboxymaltose injection,

• tell your doctor and pharmacist if you are allergic to ferric carboxymaltose injection, ferric derisomaltose (Monoferric), ferumoxytol (Feraheme), iron dextran (Dexferrum, Infed), iron sucrose (Venofer), or sodium ferric gluconate (Ferrlecit); any other medications, or any of the ingredients in ferric carboxymaltose 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. Also, tell your doctor if you are taking 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 low blood levels of phosphate or are unable to eat a healthy diet. Also tell your doctor if you have or have ever had a gastrointestinal disorder in which you are unable to absorb certain vitamins, a vitamin D deficiency, inflammatory bowel disease, high blood pressure, or parathyroid or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving ferric carboxymaltose injection, call your doctor. Monitor the breastfed infant for constipation or diarrhea while you are receiving ferric carboxymaltose injection. Call your doctor immediately if the breastfed infant has any of these symptoms.

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

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.

Symptoms of overdose may include:

• joint problems
• difficulty walking
• muscle weakness
• bone pain

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

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

• nausea
• vomiting
• changes in taste
• headache
• pain, swelling, itching, bleeding, or bruising in the area where medication was injected
• brown discoloration of the skin in the area where the medication was injected that may be long-lasting
• hot flashes or flushing

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency treatment:

• muscle weakness or pain
• bone or joint pain
• fatigue
• broken bones or fractures

Ferric carboxymaltose 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).

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

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

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving ferric carboxymaltose injection.

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.

• Injectafer®