Ferric Carboxymaltose (FER-ik kar-box-ee-MAWL-tose)

Treats anemia (not enough iron in the blood).

Brand Name(s):

Injectafer

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how this medicine works. Tell your doctor if you are also using an iron supplement that you take by mouth.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, high blood pressure, parathyroid problems, malnutrition, vitamin D deficiency, stomach or bowel problems (including inflammatory bowel disease), or a history of trouble absorbing vitamins or phosphate in your body. Tell your doctor if you have had an allergic reaction to injectable iron products.
• This medicine may cause high blood pressure.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone, joint, or muscle pain, fractures, loss of appetite, seizures, unusual tiredness or weakness
• Chest pain, trouble breathing
• Fast, slow, or pounding heartbeat
• Lightheadedness, dizziness, fainting
• Warmth or redness in your face, neck, arms, or upper chest

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea, vomiting
• Pain, discoloration, or a bruise under your skin where the needle is placed
• Skin rash or redness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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