Gadoteridol

Gadoteridol is a contrast agent that has magnetic properties. It is used together with magnetic resonance imaging (MRI) to make blood vessels, organs, and other non-bony tissues clearer on the MRI.

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

Gadoteridol may also be used for other reasons not mentioned in this medication guide.

Gadoteridol 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.

Gadoteridol can cause a serious, life-threatening condition in people who have advanced kidney disease. Before getting gadoteridol, inform your doctor if you have kidney disease or if you are on dialysis. You might not be able to receive gadoteridol. Also, let your doctor know if you have recently had any contrast agents similar to gadoteridol.

Gadoteridol can cause a serious condition in people with advanced kidney disease. Talk to your doctor about your specific risk.

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

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

Inform your doctor if you have ever had:

• any type of reaction to a contrast agent;
• diabetes;
• asthma, hay fever, food or drug allergies;
• high blood pressure; or
• kidney disease (or if you are on dialysis).

Let your doctor know 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 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;
• skin redness or discoloration;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• pain; or
• tiredness, trouble moving.

Gadoteridol may cause serious side effects. 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:

• headache;
• 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.

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).

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

In a healthcare environment, an overdose would be managed promptly.

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

Other drugs may impact gadoteridol, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.