Pronunciation:

FER-ik kar-box-ee-MAWL-tose

Brand Names:

• Injectafer

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Iron Supplement

Uses of This Medicine:

Ferric carboxymaltose injection is an iron replacement product that is used to treat iron deficiency anemia (not enough iron in the blood) in patients with non-dialysis dependent chronic kidney disease (CKD), in patients who cannot take iron supplements or who are taking iron supplements that did not work well, and in patients with heart failure to improve the ability to exercise.

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.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ferric carboxymaltose injection in children younger than 1 year of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ferric carboxymaltose injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Baloxavir Marboxil
• Bictegravir
• Dimercaprol
• Eltrombopag
• Erdafitinib
• Magnesium Sulfate
• Raltegravir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Delafloxacin
• Minocycline
• Zinc

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Phytic Acid Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia that is not caused by iron deficiency or
• Iron overload—Use is not recommended in patients with these conditions.

• Hyperparathyroidism (overactive parathyroid glands) or
• Kidney disease or
• Malabsorption of fat-soluble vitamins and phosphate, history of or
• Malnutrition or
• Stomach or bowel problems (eg, inflammatory bowel disease) or
• Vitamin D deficiency—Use with caution. May increase risk for hypophosphatemia (low phosphate in the blood).

• Hypertension (high blood pressure—Use with caution. May make these conditions worse.

• Liver disease—May increase risk to develop iron overload.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

Check with your doctor right away if you have bone, joint, or muscle pain, fractures, loss of appetite, trouble breathing, seizures, or unusual tiredness or weakness. These may be symptoms of hypophosphatemia (low phosphate in the blood).

This medicine may cause high blood pressure. Tell your doctor or nurse right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat after receiving the injection.

Make sure your doctor knows if you are also using other iron supplements. Also, tell your doctor if you have had an allergic reaction to injectable iron products.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Blurred vision

bone pain

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling of warmth

headache

loss of appetite

nervousness

pounding in the ears

redness of the face, neck, arms, and occasionally, upper chest

seizures

slow or fast heartbeat

sweating

trouble breathing

unusual tiredness or weakness

Incidence not known

Chest discomfort or tightness

chills

cough

difficult or labored breathing

difficulty swallowing

fainting

fast, pounding, or irregular heartbeat or pulse

fever

hives, itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Nausea

Less common

Change in taste

discoloration at the injection site

loss of taste

vomiting

Rare

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

constipation

diarrhea

pain or irritation at the injection site

sneezing

stomach pain

Incidence not known

Back pain

difficulty with moving

muscle pain or stiffness

pain in the joints

redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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