Gadoterate Meglumine (gad-oh-TER-ate MEG-loo-meen)

Used to help create pictures of the brain, spine, head, neck, and other parts of the body during magnetic resonance imaging (MRI) scans. This medicine is a gadolinium-based contrast agent (GBCA).

Brand Name(s):

Clariscan, Dotarem

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It is given just before you have an MRI scan.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

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, diabetes, high blood pressure, any type of infection, or a history of asthma or allergies. Tell your doctor if you have recently received another GBCA, or if you have had an allergic reaction to any contrast agent.
• This medicine may cause the following problems:
  • Serious unwanted effects including brain problems (encephalopathy), death, coma, and seizures, when given intrathecally (injection given through the spinal canal)
  • Nephrogenic systemic fibrosis (NSF)
  • Acute kidney injury (AKI)
  • Injection site reactions
• This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin) for a long time (several months to years). Talk to your doctor if you have concerns about this.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
• Change in how much or how often you urinate, dark urine, swelling in your hands, ankles, or feet
• Rash, swelling, hardness, burning, itching, or red or dark patches on your skin
• 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:

• Pain, itching, burning, 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