Gadoxetate 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.

Gadoxetate is used to help diagnose certain disorders of the liver.

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

Gadoxetate 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.

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

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when gadoxetate is injected.

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.

Gadoxetate can affect the results of certain medical tests for at least 24 hours after your MRI. Tell any doctor who treats you that you have received gadoxetate

Usual Adult Dose for Liver Magnetic Resonance Imaging:

0.1 mL/kg body weight(0.025 mmol/kg body weight) administered undiluted as a single intravenous bolus injection at a flow rate of approximately 2 mL/second.

Gadoxetate 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.

Gadoxetate can stay in your body for months or years after you receive gadoxetate. 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 gadoxetate 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;

• asthma, hay fever, food or drug allergies;

• an injury, surgery, or severe infection; or

• if you are over 60 years old.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed for at least 10 hours after receiving gadoxetate. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

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

Since gadoxetate 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; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

Gadoxetate 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;

• tiredness, 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 dark patches.

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; or

• swelling, irritation, or skin changes where the injection was given.

Common side effects of gadoxetate may include:

• headache, back pain;

• dizziness;

• nausea; or

• feeling hot.

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 gadoxetate, 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.