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Gadobutrol (Injection) (Injectable)

(GADAVIST)
Gadobutrol (By injection)
Gadobutrol (gad-oh-BUE-trol)A contrast agent used to help create pictures of the brain, spinal cord, or breast during magnetic resonance imaging (MRI) scans. Also used for magnetic resonance angiography (MRA).
Gadavist

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 gadobutrol.

How to Use This Medicine:
Injectable

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

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 problems, asthma, allergies, or you had an allergic reaction to any contrast agent.
  • This medicine may cause the following problems:
    • Nephrogenic systemic fibrosis (NSF)
    • Acute kidney injury

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, or swelling in your hands, ankles, or feet
  • Fast, pounding, or uneven heartbeat
  • 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
  • Rash, swelling, hardness, tightness, burning, itching, or red or dark patches on your skin

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