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Gadoteridol (Injection) (Injectable)

(PROHANCE)
Gadoteridol (By injection)
Gadoteridol (gad-oh-TER-i-dol)This medicine is a gadolinium-based contrast agent (GBCA) that is used to help create a clear picture of the body during magnetic resonance imaging (MRI) scans.
Prohance

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

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. This medicine is given just before you have an MRI 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, liver disease, anemia, sickle cell anemia, asthma, diabetes, high blood pressure, or a history of seizures.
  • This medicine may cause the following problems:
    • Nephrogenic systemic fibrosis (NSF)
    • Acute kidney injury (AKI)
  • Your doctor will check your progress and the effects of this medicine at regular visits. 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, blood in your urine
  • Chest pain
  • Confusion, restlessness, or increased salivation
  • Fast, slow, pounding, or uneven heartbeat
  • Fever
  • Lightheadedness, dizziness, or fainting
  • Muscle stiffness, weakness, stiff joints, trouble with moving, or deep bone pain
  • Numbness, tingling, or burning pain in your hands, arms, legs, or feet
  • Rash or redness of the skin
  • Swelling, hardness, tightness, burning, itching, or red or dark patches on the skin
  • Warmth or redness in your face, neck, arms, or upper chest

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