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Gadobutrol (Injection)

Gadobutrol (gad-oh-BUE-trol)

Used in magnetic resonance imaging (MRI) scans. Helps your doctor to see images of your brain, spine, and other parts of your body. This medicine is a gadolinium-based contrast agent (GBCA).

Brand Name(s):

Gadavist

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this medicine if you or your child have had an allergic reaction to gadobutrol or other gadolinium-based contrast agents. If you have severe or long-term kidney problems, this medicine should not be used unless your doctor tells you it is necessary.

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 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:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, asthma, other allergic conditions, or a history of an allergic reaction to any contrast agent.
  • Check with your doctor or nurse right away if you or your child have burning or itching of the skin; deep bone pain in the hips or ribs; joint stiffness; a limited range of motion in the arms and legs; muscle weakness; red or dark patches on the skin of the arms or legs; or skin swelling, hardening, or tightening within the first few days or weeks after you receive this medicine. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).
  • This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.
  • Tell your doctor right away if you or your child have burning pain; feeling of warmth or coldness; or redness at the injection site.

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, or blood in your urine.
  • Fast, pounding, or uneven heartbeat.
  • Lightheadedness, dizziness, or fainting.
  • Muscle stiffness or weakness, stiff joints or trouble moving, or deep bone pain.
  • Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
  • Shortness of breath or troubled breathing.
  • Skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches.

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

  • Bad taste in your mouth.
  • Dry mouth, nausea, or vomiting.
  • Headache.
  • Mild skin rash or itching.
  • Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
  • Warmth or redness in your face, neck, arms, or upper chest.

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


Last Updated: 10/4/2014


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