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Generic Name: ferric carboxymaltose
Date of Approval: July 25, 2013
Company: Luitpold Pharmaceuticals Inc.

Treatment for: Iron Deficiency Anemia

FDA Approves Injectafer

The U.S. Food and Drug Administration has approved Injectafer (ferric carboxymaltose injection), a parenteral iron replacement product used for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron. Injectafer is also indicated for iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease (NND-CKD).

Injectafer Patient Information

Please read this information carefully before taking this medication. This summary does not tell you everything about Injectafer. Speak with your doctor or healthcare professional if there is something you do not understand or if you would like to learn more about Injectafer. Your doctor or healthcare professional is your best source of information about this medicine.

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What is Injectafer?

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Injectafer is used to treat iron deficiency anemia. Iron deficiency anemia may be caused by several medical conditions including heavy menstrual bleeding, pregnancy, childbirth, inflammatory bowel disease, other malabsorption diseases, bariatric surgery, or chronic kidney disease.

General information about using Injectafer safely and effectively

Injectable iron is administered only by or under the supervision of your health care professional.

Serious or life threatening allergic reactions have been reported with intravenous iron products. Tell your health care professional if you have ever had any unusual or allergic reaction to any IV iron.

Patients should report to their healthcare professional any signs and symptoms of an allergic reaction to Injectafer, in particular rashes, shortness of breath and wheezing.

Iron is not easily eliminated from the body, and its build up may be lead to a condition called iron overload which may be harmful. Certain medical conditions such as liver disease may also make you more likely to develop iron overload. Ask your doctor or healthcare professional.

Who should not take Injectafer?

You should not be given Injectafer if you have anemia that is not caused by iron deficiency, or if you have iron overload.

If you are pregnant or plan to become pregnant please notify your doctor or healthcare professional. They will decide whether it is safe for you to receive Injectafer.

How should I take Injectafer?

Injectafer is administered intravenously (into your vein) by your doctor or health care professional in two doses.

What should I avoid?

You should not take iron supplements by mouth if you are receiving iron injections. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Injectafer side effects

The side effects of Injectafer are infrequent, usually mild and generally do not cause patients to stop treatment. The most common side effects are nausea, injection site reactions (including pain or bruising at the injection site), asymptomatic reductions in blood phosphorus, flushing, headache, hypertension, dizziness, and increased alanine aminotransferase. Potentially long lasting brown staining of skin near injection site may occur.

These are not all the possible side effects of Injectafer. For more information ask your doctor or healthcare professional. Talk to your doctor if you think you have side effects from taking Injectafer.