Gadobutrol

Gadobutrol is a contrast agent used in combination with MRI to allow blood vessels, organs, and other non-bony tissues to be seen more clearly. It is used to help diagnose certain disorders of the brain and spine (central nervous system), the blood vessels of the kidneys, and the heart. Gadobutrol is also used with MRI of the breast to help detect breast cancer.

• Gadobutrol is available under various brand names: Gadavist

Common side effects of Gadobutrol include:

• headache.
• nausea; or
• dizziness.

Serious side effects of Gadobutrol include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• burning, itching, swelling, scaling, and tightening or hardening of the skin.
• muscle weakness.
• joint stiffness in the arms, hands, legs, or feet.
• deep bone pain in the ribs or the hips.
• trouble moving; or
• skin redness or discoloration.
• kidney problems--little or no urinating; painful or difficult urination; swelling in the feet or ankles; feeling tired or short of breath.

Rare side effects of Gadobutrol include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 1 mmol/mL (.e, 604.72 mg/mL)

Diagnostic imaging: IV:

Adult dosage

• Breast malignancy imaging, CNS imaging, and supra-aortic or renal artery angiography: 0.1 mmol/kg (0.1 mL/kg); may begin imaging immediately after administration
• Cardiac imaging: 
• 0.05 mmol/kg (0.05 mL/kg) at peak pharmacological stress, followed by 0.05 mmol/kg (0.05 mL/kg) at rest
• Pediatric dosage
• CNS imaging and supra-aortic or renal artery angiography: Infants, Children, and Adolescents: IV: 0.1 mmol/kg (0.1 mL/kg); may begin imaging immediately after administration.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Gadobutrol has no noted severe interactions with any other drugs.
• Gadobutrol has no noted serious interactions with any other drugs.
• Gadobutrol has no noted moderate interactions with any other drugs.
• Gadobutrol has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to Gadobutrol

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gadobutrol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gadobutrol?”

Cautions

• Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. Your doctor may check your kidney function before you receive this medicine.
• Gadobutrol can stay in your body for months or years after you receive this medicine. It is unknown whether this could cause health problems in people with normal kidneys. Tell your doctor if you have had repeated scans with a contrast agent and provide the date of your last scan.

Pregnancy and Lactation

• It is not known whether this Gadobutrol will harm an unborn baby. Tell your doctor if you are pregnant.

Lactation

• It may not be safe to breastfeed while using this Gadobutrol. Ask your doctor about any risks.