Gadobutrol

Pronunciation: Pronunciation not available.

Generic name: gadobutrol
Brand names: Gadavist
Drug class: Gadolinium-based contrast agent (GBCA)
Route: Intravenous injection

Availability and supply rules vary by country

Trade names by country: United States · Canada

What gadobutrol is and how it works

Gadobutrol is a gadolinium-based contrast agent used intravenously to enhance magnetic resonance imaging (MRI) scans. It helps detect abnormalities in the central nervous system, breast, blood vessels, and heart. (1)

Gadobutrol is administered by trained healthcare personnel via IV injection; it is not self-administered.

Mechanism of action: how gadobutrol works

Gadobutrol is a gadolinium-based contrast agent that improves visualization of tissues during MRI scans. (1)

What gadobutrol is used for

Central nervous system (CNS) imaging

Gadobutrol is indicated for contrast-enhanced MRI of the CNS to detect and visualize areas with disrupted blood-brain barrier or abnormal vascularity in adults and pediatric patients, including term neonates. (1)

Breast MRI

It is used for contrast-enhanced MRI of the breast to assess the presence and extent of malignant disease in adult patients. (1)

Magnetic resonance angiography (MRA)

Gadobutrol is indicated for contrast-enhanced MRA to evaluate supra-aortic or renal artery disease in patients undergoing vascular imaging. (1)

Cardiac MRI

It is used for contrast-enhanced perfusion MRI of the heart to assess myocardial perfusion in patients with known or suspected coronary artery disease. (1)

Before taking gadobutrol

Do not take / not appropriate for

A history of severe hypersensitivity reaction to Gadavist is a contraindication per the source reviewed; your clinician or imaging team will assess whether this applies to you. (all products) (1)
Gadobutrol carries a boxed warning: the risk of nephrogenic systemic fibrosis (NSF) is highest in patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury. Your clinician will assess whether this applies to you. (all indications) (1)

Tell your clinician about

Any previous severe hypersensitivity reaction to Gadavist.
Any kidney problems, including chronic kidney disease, acute kidney injury, or if you are on dialysis.
If you are pregnant or think you might be pregnant.
If you are breastfeeding.

(1)

How to take gadobutrol

Gadobutrol is given as an intravenous injection by a trained healthcare professional in a clinical setting.
The dose is based on your actual body weight and the type of MRI examination. The standard dose is 0.1 mmol per kilogram of body weight (0.1 mL/kg). For cardiac MRI, the total dose is divided into two equal injections of 0.05 mmol/kg each.

(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician.

Missed dose

This medicine is administered by trained healthcare personnel as part of a scheduled imaging procedure; it is not self-administered, so a missed-dose concept does not apply.

Overdose

This medicine is dosed and given by trained healthcare personnel based on body weight; it is not self-administered. Specific overdose-management procedures were not established in the source reviewed for this page; unresolved. (1)

Side effects

The most common side effects are headache, nausea, and dizziness. Serious allergic reactions, including anaphylaxis, can occur. After administration of any gadolinium-based contrast agent, gadolinium is retained for months or years in the brain, bone, and other organs.

Headache

What to notice: Headache, ranging from mild to moderate.

What to do: Tell your healthcare team. (1)

Nausea

What to notice: Nausea, as reported in clinical trials (1.2%).

What to do: Tell the staff if it is severe. (1)

Dizziness

What to notice: Dizziness, as reported in clinical trials (0.5%).

What to do: Tell your healthcare team. (1)

Nephrogenic systemic fibrosis (NSF)

What to notice: NSF can cause fatal or debilitating fibrosis affecting the skin, muscle, and internal organs, as described in the boxed warning; specific symptom presentation was not detailed in the source reviewed.

What to do: Seek medical attention promptly. (1)

Serious warnings

Nephrogenic systemic fibrosis (NSF) — warning

Symptoms: NSF can cause fatal or debilitating fibrosis affecting the skin, muscle, and internal organs, per the boxed warning; specific symptom presentation was not detailed in the source reviewed.

Action: Seek medical attention promptly. (1)

Hypersensitivity reactions (including anaphylaxis) — emergency

Symptoms: Anaphylactic reactions with life-threatening and fatal outcomes have occurred, per the source reviewed; specific symptom presentation was not detailed there.

Action: Seek emergency medical attention promptly. (1)

Acute respiratory distress syndrome — emergency

Symptoms: Reported with onset within 24 hours of administration, per the source reviewed; specific symptom presentation was not detailed there.

Action: Seek emergency medical care promptly. (1)

Interactions

Medicine or test	Effect	Action
Other medicines	No drug-drug interaction data was found in the source reviewed for this page; unresolved rather than confirmed absent.	Inform your healthcare provider about all medicines you are taking before the MRI. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Use only if imaging is essential and cannot be delayed. Gadolinium crosses the placenta and may pose risks to the fetus. Animal studies showed embryolethality at high doses. (1)

Breastfeeding

Limited gadolinium enters breast milk (estimated 0.01-0.04% of the maternal dose), per the source reviewed. Discuss this with your doctor. (1)

Children and neonates

Gadobutrol's standard weight-based dosing applies to adults and pediatric patients, including term neonates, per the source reviewed. (1)

Patients with kidney disease

People with severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury are at increased risk of developing nephrogenic systemic fibrosis (NSF). The decision to use gadobutrol in these patients must be carefully weighed by the clinician. (1)

Monitoring

Before starting

A specific pre-procedure monitoring checklist was not established in the source reviewed for this page; unresolved.

During treatment

A specific during-procedure monitoring protocol was not established in the source reviewed for this page; unresolved.

(1)

Storage

This medicine is administered by trained healthcare personnel; patients do not self-store it.

Professional information

Clinician-facing context. Use the current FDA-approved label and institutional protocols.

United States (FDA-sourced label, via Drugs.com)

Indication: MRI contrast enhancement per approved indications

Dose summary: Standard dose is 0.1 mmol/kg (0.1 mL/kg) of actual body weight, administered intravenously. For cardiac MRI, the total dose is divided into two equal injections of 0.05 mmol/kg each. Use in pediatric patients (including term neonates) for CNS imaging is based on body weight.

Renal context: No specific renal dose-adjustment table was found in the source reviewed; unresolved. The boxed warning notes increased NSF risk in patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury. (1)

Mechanism of action

Hepatic guidance

No specific hepatic impairment guidance was found in the reviewed source.

Overdose note

Specific overdose-management procedures were not established in the source reviewed for this page; unresolved. (1)

Frequently asked questions

What is gadobutrol used for?

It is a contrast agent used to enhance MRI scans of the brain, breast, blood vessels, and heart in certain patients. (1)

Can I receive gadobutrol if I have kidney problems?

If you have severe kidney disease or acute kidney injury, you may be at increased risk of a serious condition called nephrogenic systemic fibrosis. Your doctor will decide whether the imaging is necessary. (1)

Is gadobutrol safe during pregnancy?

It should only be used if the imaging is essential and cannot be delayed. Gadolinium can cross the placenta. Talk to your doctor. (1)

Will I have any side effects?

Common side effects include headache, nausea, and dizziness. Serious allergic reactions can occur. (1)

Can I breastfeed after receiving gadobutrol?

A small amount of gadobutrol passes into breast milk (estimated 0.01-0.04% of the maternal dose), per the source reviewed. Discuss this with your doctor. (1)

What is the mechanism of action of gadobutrol?