When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to gadoxetate.

How to Use This Medicine:
Injectable

• A nurse or other health provider will give you this medicine. It is given through a needle placed in a vein, just before you have an MRI scan.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, asthma, allergies, diabetes, or high blood pressure. Tell your doctor if you had an allergic reaction to any contrast agent.
• This medicine may cause kidney injury or nephrogenic systemic fibrosis, especially in people who already have kidney problems. Nephrogenic systemic fibrosis is a rare syndrome that causes thickened skin and can also affect your internal organs.
• Tell any doctor who treats you that you have been given this medicine. It can affect certain medical tests for a short period after you receive it.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much or how often you urinate, confusion, dizziness, swelling in your hands, ankles, or feet
• Hardness or tightness of your skin, red or dark patches on your skin or skin rash
• Muscle weakness, stiff joints or trouble moving, bone pain

If you notice these less serious side effects, talk with your doctor:

• Pain, burning, itching, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088