Gadoterate meglumine

Gadoterate meglumine is a contrast agent that has magnetic properties. It is used with magnetic resonance imaging (MRI) to help see blood vessels, organs, and other non-bony tissues more clearly.

Gadoterate meglumine is used to help diagnose certain disorders of the brain and spine (central nervous system).

Gadoterate meglumine may also be used for purposes not listed in this medication guide.

Gadoterate meglumine is given as an infusion into a vein. A healthcare provider will give you this injection.

You will be monitored for a short time to ensure you do not have an allergic reaction.

Gadoterate meglumine can lead to a serious condition in people with advanced kidney disease. Before getting gadoterate meglumine, inform your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadoterate meglumine. Also, let your doctor know if you have recently had any contrast agents similar to gadoterate meglumine.

Gadoterate meglumine can cause a serious condition in people with advanced kidney disease. Ask your doctor about your personal risk.

Gadoterate meglumine can remain in your body for months or years after you receive it. It is not known if this could lead to any health issues in people with normal kidney function. Inform your doctor if you have had multiple scans with a contrast agent, and provide the date of your last scan.

You should not receive gadoterate meglumine if you are allergic to it.

Tell your doctor if you have ever had:

• any kind of reaction to a contrast agent;
• diabetes;
• high blood pressure;
• asthma, hay fever, food or drug allergies; or
• liver or kidney disease.

Inform your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects of gadoterate meglumine may happen up to several days after the injection.

Gadoterate meglumine can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;
• skin redness or discoloration;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• pain;
• tiredness, trouble moving; or
• kidney problems—little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects of gadoterate meglumine may include:

• headache;
• altered sense of taste, nausea;
• rash; or
• pain, burning, irritation, or skin changes where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose will be treated quickly.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may affect gadoterate meglumine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.