When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to gadoterate or other gadolinium-based contrast agents.

How to Use This Medicine:
Injectable

• A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a test.
• You may need a blood or urine test before you are given this medicine, to make sure your kidneys are healthy enough to process it.

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:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease or other problems. Tell your doctor if you have recently received another gadolinium-based contrast agent (GBCA), or if you have a history of asthma or allergies, especially to other contrast agents or drugs.
• Patients who have severe kidney disease have a higher risk of nephrogenic systemic fibrosis (NSF), a serious condition. Make sure your doctor knows if you have diabetes or high blood pressure, because you are more likely to have kidney problems. Tell your doctor right away if you have tight or hardened skin, stiff joints or muscles, bone pain in your hips or ribs, trouble moving your arms or legs, or muscle weakness. These may be symptoms of NSF.

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, lower back pain
• Tight or hardened skin, stiff joints or muscles, bone pain, trouble moving your arms or legs, muscle weakness

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

• Headache
• Pain, itching, burning, swelling, warm or cold feeling 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