Gadolinium-based Contrast Agents

IMPORTANT WARNING:

Gadolinium-based contrast agents (GBCAs) may cause problems with your skin, muscles, and other organs in your body.Tell your doctor if you have or have ever had kidney problems or have previously had a magnetic resonance imaging (MRI) scan.If you experience any of the following symptoms, call your doctor immediately: burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

GBCAs must not be given by intrathecal (into the space around the spinal cord) injection.

Keep all appointments with your doctor and the laboratory.

Your healthcare provider will give you the manufacturer's patient information sheet (Medication Guide) before you begin the MRI test with a GBCA. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving GBCAs.

WHY is this medicine prescribed?

GBCAs are used at the time of a magnetic resonance imaging (MRI; a test that creates clear images of the structures inside your body using a large magnet, radio waves and a computer) scan to allow your doctor to see images of your brain,spine,heart, liver, breast(s), certain blood vessels,and other areas inside your body.Gadolinium-based contrast agents are in a class of medications called paramagnetic contrast agents.It works to improve the quality of the images seen by a MRI scan.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

GBCAs come as a solution (liquid) to be injected into a vein at the time of your MRI scan by a healthcare provider.Your doctor will give a dose of the medication that is best for you.

What SPECIAL PRECAUTIONS should I follow?

Before receiving a GBCA

• tell your doctor and pharmacist if you are allergic to dyes or any GBCA, any other medications, or any of the ingredients in the injection.Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.

• tell your doctor if you are over 60 years of age or if you have or have ever had high blood pressure, diabetes, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.

What SIDE EFFECTS can this medicine cause?

Gadolinium-based contrast agents may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• burning, pain, or feeling of warmth or coldness at or around the injection site
• headache
• nausea

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• rash, itching, hives, dizziness, or difficulty breathing or swallowing

GBCAs may stay in certain areas of your body such as the brain, bones, and skin in small amounts for months or years, especially if you have kidney problems.Talk to your doctor about the risks of taking this medication.

GBCAs may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.