Ferric carboxymaltose is an iron replacement product that is used in adults used to treat iron deficiency anemia (IDA), which is low red blood cells caused by a lack of iron in the body.

Ferric carboxymaltose is given to adults with IDA and chronic kidney disease (not on dialysis), or to adults with IDA when iron taken by mouth is not effective.

Ferric carboxymaltose may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Ferric carboxymaltose is injected into a vein by a healthcare provider.

Tell your medical caregivers if you feel any burning or pain when ferric carboxymaltose is injected.

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

This medicine is usually given in 2 doses, 7 days apart.

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

Usual Adult Dose for Iron Deficiency Anemia:

Patients weighing 50 kg or more:
-Two doses of 750 mg via slow IV push or infusion separated by at least 7 days
-An alternative dose of 15 mg/kg to a maximum of 1,000 mg may be administered as a single-dose treatment course.
Maximum dose: Total cumulative dose should not exceed 1500 mg of iron per course

Patients weighing less than 50 kg:
-Two doses of 15 mg/kg via slow IV push or infusion separated by at least 7 days

Comments:
-Each mL of this drug contains 50 mg of elemental iron. The dosage is expressed in mg of elemental iron.
-Treatment may be repeated if iron deficiency anemia recurs.

Use: Treatment of iron deficiency anemia in adults with an intolerance or unsatisfactory response to oral iron and in adults with non-dialysis dependent chronic kidney disease

Usual Pediatric Dose for Iron Deficiency Anemia:

Patients weighing 50 kg or more:
-Two doses of 750 mg via slow IV push or infusion separated by at least 7 days
-An alternative dose of 15 mg/kg to a maximum of 1,000 mg may be administered as a single-dose treatment course.
Maximum dose: Total cumulative dose should not exceed 1500 mg of iron per course

Patients weighing less than 50 kg:
-Two doses of 15 mg/kg via slow IV push or infusion separated by at least 7 days

Comments:
-The dosage is expressed in mg of elemental iron.
-Treatment may be repeated if iron deficiency anemia recurs.

Use: Treatment of iron deficiency anemia in pediatric patients 1 year and older with normal kidney function and with an intolerance to oral iron or an established unsatisfactory response to oral iron.

You should not use ferric carboxymaltose if you are allergic to it.

Tell your doctor if you have ever had:

• high blood pressure; or

• an allergic reaction to iron injected into a vein.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if ferric carboxymaltose will harm an unborn baby, but ferric carboxymaltose 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 ferric carboxymaltose may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea or constipation in the nursing baby.

Call your doctor for instructions if you miss an appointment for your ferric carboxymaltose injection.

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

Overdose symptoms may include pain, cough, wheezing, shortness of breath, coughing up blood, weight loss, or slowed growth in a child.

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

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

Ferric carboxymaltose may cause serious side effects. Call your doctor at once if you have:

• increased blood pressure--dizziness, nausea, sudden warmth or redness in your face, severe headache, pounding in your neck or ears;

• low levels of phosphorus in your blood--confusion, bone pain, muscle weakness; or

• high levels of iron stored in your body--feeling weak or tired, joint pain, finger pain, stomach pain, weight loss, irregular heartbeats, fluttering in your chest.

Common side effects of ferric carboxymaltose may include:

• nausea;

• dizziness;

• high blood pressure;

• flushing (warmth, redness, or tingly feeling); or

• low phosphorus levels.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect ferric carboxymaltose, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.