Ferric carboxymaltose

What it is used for

Ferric carboxymaltose injection is a prescription iron replacement medicine used for the treatment of:

• iron deficiency anemia (IDA) in:

• adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron.
• adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease).

• iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity).

It is not known if ferric carboxymaltose injection is safe and effective in children with IDA who are under 1 year of age.

It is not known if ferric carboxymaltose injectionis safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity.

Do not receive ferric carboxymaltose injection.

Do not receive ferric carboxymaltose injection if you are allergic to ferric carboxymaltose or any of the ingredients in ferric carboxymaltose injection. See the end of this Patient Information leaflet for a complete list of ingredients in ferric carboxymaltose injection.

Before receiving ferric carboxymaltose injection, tell your healthcare provider about all of your medical conditions, including if you:

• have had an allergic reaction to iron given into your vein
• have a history of trouble absorbing certain vitamins or phosphate in your body
• have inflammatory bowel disease
• have hyperparathyroidism
• have low vitamin D levels
• have high blood pressure
• have previously received ferric carboxymaltose injection
• are pregnant or plan to become pregnant. Ferric carboxymaltose injection may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ferric carboxymaltose injection.
• are breastfeeding or plan to breastfeed. Ferric carboxymaltose injection passes into your breast milk. It is not known if ferric carboxymaltose injection will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ferric carboxymaltose injection.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive ferric carboxymaltose injection ?

• Ferric carboxymaltose injectionis given into your vein (intravenously) by your healthcare provider.
• Ferric carboxymaltose injection is usually given in 2 doses at least 7 days apart for IDA, or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.
• If your healthcare provider decides it is right for you, ferric carboxymaltose injection may be given intravenously by your healthcare provider as a single-dose treatment.
• Ferric carboxymaltose injection treatment may be repeated if your healthcare provider decides it is needed. What are the possible side effects of ferric carboxymaltose injection? Ferric carboxymaltose injection may cause serious side effects, including:

• Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive ferric carboxymaltose injection and may include the following signs or symptoms:

• low blood pressure
• feeling dizzy or lightheaded
• loss of consciousness
• trouble breathing
• swelling
• fast heartbeat
• cold or clammy skin
• feet or hands turn blue
• itching
• rash
• hives
• wheezing Your healthcare provider will watch you during and for at least 30 minutes after you receive ferric carboxymaltose injection. Tell your healthcare provider right away if you develop any signs or symptoms of allergic reactions during or after treatment with ferric carboxymaltose injection.

• Symptoms of low blood phosphate levels. Ferric carboxymaltose injection may cause low levels of phosphate in your blood that may be serious and can lead to softening of your bones and broken bones (fractures), especially in people who have received multiple ferric carboxymaltose injection treatments. Your healthcare provider may check your blood phosphate levels before a repeat treatment with ferric carboxymaltose injection if you are at risk for low blood phosphate levels. If a repeat treatment is needed within 3 months of your last treatment your healthcare provider should check your blood phosphate levels. Tell your healthcare provider if you develop any of the following signs or symptoms of low blood phosphate levels during treatment with ferric carboxymaltose injection:

• feeling very tired
• muscle weakness or pain
• bone or joint pain
• broken bones High blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with ferric carboxymaltose injection. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive ferric carboxymaltose injection. The most common side effects of ferric carboxymaltose injection in adults include:

• nausea
• high blood pressure
• flushing
• injection site reactions
• skin redness
• low levels of phosphate in your blood
• dizziness

The most common side effects of ferric carboxymaltose injection in children include:

• low levels of phosphate in your blood
• injection site reactions
• rash
• headache
• vomiting

These are not all the possible side effects of ferric carboxymaltose injection.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ferric carboxymaltose injection.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about ferric carboxymaltose injection that is written for health professionals.