Gadoxetate

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

Gadoxetate is used to help diagnose certain liver disorders.

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

Gadoxetate 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.

Gadoxetate can affect the results of certain medical tests. Inform any doctor who treats you that you are using gadoxetate.

Gadoxetate can cause a serious and potentially life-threatening condition in people with advanced kidney disease. Before getting gadoxetate, inform your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadoxetate. Also, let your doctor know if you have recently received any contrast agents similar to gadoxetate.

Gadoxetate can lead to a serious and life-threatening condition in individuals with advanced kidney disease. Discuss your specific risk with your doctor.

Gadoxetate may remain in your body for months or even 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 most recent scan.

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

Notify your doctor if you have ever experienced:

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

It is unclear if gadoxetate could harm an unborn baby. Let your doctor know if you are pregnant or planning to become pregnant.

Inform your doctor if you are breastfeeding. Do not breastfeed for 10 hours after using gadoxetate. If you use a breast pump during this time, discard the milk and do not give it to your baby.

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;
• skin redness or dark patches;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• pain; or
• tiredness, trouble moving.

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

Common side effects of gadoxetate may include:

• headache, back pain;
• dizziness;
• altered sense of taste, 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.

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.

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

In a medical setting, an overdose would be handled quickly.

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

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.