ferric carboxymaltose 100 mg iron/2 mL intravenous solution

Generic name:
Ferric carboxymaltose - injection

Pronunciation
(FER-ik kar-BOX-ee-MAWL-tose)

Brand name(s)
Injectafer

This medication may rarely cause serious low phosphate levels. You may be at increased risk if you have a history of stomach/intestinal problems (such as malabsorption, bowel disease), parathyroid problems, low vitamin D levels, nutrient deficiency (malnutrition), or certain genetic conditions (such as hereditary hemorrhagic telangiectasia-HHT or Osler-Weber-Rendu syndrome). Tell your doctor right away if you have any symptoms of low phosphate such as muscle pain or weakness, bone pain, joint pain, or bone fractures.

This medication is used to treat "iron-poor" blood (iron deficiency anemia). Low iron levels can occur due to many conditions, including when your body cannot get enough iron from food (because of poor nutrition or poor absorption) or when there is long-term blood loss. Ferric carboxymaltose is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. It is also used by people who have anemia due to long-term kidney disease or heart failure.

Iron is an important mineral that your body needs to make enough healthy red blood cells to carry oxygen throughout your body.

Read the Patient Information Leaflet if available from your pharmacist before you start using ferric carboxymaltose and with each treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional as directed by your doctor. The dosage is based on your medical condition, weight, lab tests, and response to treatment.

See also Warning section.

Pain, irritation, or bruising at the injection site may occur. Flushing, nausea, or dizziness may also occur. Brown staining of the skin around the injection site may occur and can be long lasting. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

An increase in your blood pressure, sometimes along with dizziness, nausea, or flushing of the face, may rarely occur right after a dose of this medication, but these effects usually go away within 30 minutes. Tell your doctor right away if your blood pressure remains high or if these symptoms last or get worse.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using ferric carboxymaltose, tell your doctor or pharmacist if you are allergic to it; or to other iron injection products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• dimercaprol
• other iron-containing products

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, iron/phosphate levels) should be done while you are using this medication. Keep all medical and lab appointments.

It is best to get your vitamins and minerals from the food you eat. Eat a well-balanced diet. Follow your doctor's advice about what foods are best for you. Foods rich in iron include red meats (especially liver), fish, beans, dried fruit, and iron-fortified/enriched cereals and bread.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.