Gadoteridol is a contrast agent that has magnetic properties. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.

Gadoteridol is used to help diagnose certain disorders of the head and neck, or brain and spine (central nervous system).

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

Gadoteridol can cause a life-threatening condition in people with advanced kidney disease. Before receiving gadoteridol, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadoteridol. Also tell your doctor if you have recently received any contrast agents similar to gadoteridol.

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

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

Usual Adult Dose for CNS Magnetic Resonance Imaging:

Central Nervous System:
0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min). In patients suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans, a second dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose.

Extracranial and Extraspinal Tissues:
0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min).

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

Central Nervous System - to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues:
over 2 years of age:
0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min).

Gadoteridol can cause a life-threatening condition in people with advanced kidney disease. You should not receive this medication if you have kidney disease or if you are on dialysis.

Gadoteridol can stay in your body for months or years after you receive this medicine. It is not known whether this could cause any health problems in people whose kidneys work properly. Tell your doctor if you have had repeated scans with a contrast agent, and provide the date of your last scan.

You should not receive gadoteridol if you are allergic to it.

Tell your doctor if you have ever had:

• kidney problems;

• any type of reaction to a contrast agent;

• diabetes;

• high blood pressure;

• liver disease;

• anemia or other red blood cell disorder;

• a seizure;

• asthma, hay fever, food or drug allergies;

• an injury, surgery, or severe infection; or

• if you are over 60 years old.

Tell your doctor if you are pregnant or breastfeeding.

Since gadoteridol is used only during your MRI, you will not be on a dosing schedule.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Some side effects of gadoteridol may occur up to several days after injection.

Gadoteridol 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;

• muscle weakness;

• joint stiffness in your arms, hands, legs, or feet;

• deep bone pain in your ribs or your hips;

• trouble moving; or

• skin redness or discoloration.

Also call your doctor at once if you have:

• kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

• a seizure (convulsions); or

• a light-headed feeling, like you might pass out.

Common side effects of gadoteridol may include:

• nausea; or

• unusual or unpleasant taste in your mouth.

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.

Other drugs may affect gadoteridol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.