Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Gadavist

Descriptions


Gadobutrol injection is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of procedure that let a doctor look at the inside of the body, such as the brain. They use magnets and computers to create images or “pictures” of the body. Unlike x-rays, MRI scans do not involve radiation. Gadobutrol is a gadolinium-based contrast agent (GBCA) that is given by injection before the MRI to help diagnose problems in the brain, spine, breast, and other parts of your body.

This medicine is to be used only by or under the direct supervision of a doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadobutrol injection in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadobutrol injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving gadobutrol.

Pregnancy

Information about this gadobutrol-intravenous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergic disorders or
  • Bronchial asthma, history of—Use with caution. May be at increased risk for an allergic reaction to this medicine.
  • Kidney problems, severe (recent or long-term)—Should not be used in patients with this condition unless your doctor specifically tells you that it is necessary.

Proper Use

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.

Precautions

It is very important that your doctor check the progress of you or your child while you are receiving this medicine and during the MRI scan. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

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 chest pain, cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, or trouble with breathing after you receive the medicine.

This medicine may increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased with high doses of gadobutrol.

Tell your doctor right away if you or your child have burning pain, feeling of warmth or coldness, redness or swelling at the injection site.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

  1. Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  2. blurred vision
  3. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. confusion
  5. convulsions
  6. difficult or labored breathing
  7. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  8. fast, pounding, or irregular heartbeat or pulse
  9. feeling of warmth
  10. general feeling of discomfort or illness
  11. hives or welts, itching, or skin rash
  12. loss of consciousness
  13. paleness of the skin
  14. redness of the face, neck, arms, and occasionally, upper chest
  15. redness of the skin
  16. sweating
  17. tightness in the chest
  18. unusual tiredness or weakness

Incidence not known

  1. Bluish color of the fingernails, lips, skin, palms, or nail beds
  2. burning sensation
  3. burning, dry, or itching eyes
  4. chest pain
  5. cough
  6. deep bone pain
  7. difficulty with swallowing
  8. discharge or excessive tearing
  9. hoarseness
  10. increased sweating
  11. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  12. muscle stiffness or weakness
  13. no blood pressure or pulse
  14. no breathing
  15. noisy breathing
  16. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  17. skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches
  18. slow or irregular breathing
  19. sneezing
  20. stiff joints or trouble moving
  21. stopping of the heart
  22. swelling of the mouth or throat
  23. unconsciousness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Headache
  2. nausea

Rare

  1. Change in sense of smell
  2. change in taste
  3. dizziness
  4. dry mouth
  5. feeling hot or cold
  6. loss of taste
  7. unusually warm skin
  8. vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.