Gadobutrol

In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: • Differences in proton density • Differences of the spin-lattice or longitudinal relaxation times (T 1 ) • Differences in the spin-spin or transverse relaxation time (T 2 ) When placed in a magnetic field, gadobutrol shortens the T 1 and T 2 relaxation times. The extent of decrease of T 1 and T 2 relaxation times, and therefore the amount of signal enhancement obtained from gadobutrol, is based upon several factors including the concentration of gadobutrol in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times.

• Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates ( 1.1 ) • To assess the presence and extent of malignant breast disease in adult patients ( 1.2 ) • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates ( 1.3 ) • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). ( 1.4 ).

• Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection.contraindicated

• Recommended dose for adults and pediatric patients (including term neonates) is 0.1 mL/kg body weight ( 2.1 ) • Administer as an intravenous bolus injection ( 2.2 ) • Follow injection with a normal saline flush ( 2.2 ) 2.1 Recommended Dose The recommended dose of gadobutrol injection for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg). Refer to Table 1 to determine the volume to be administered. Table 1: Volume of Gadobutrol Injection by Body Weight* Body Weight (kg) Volume to be Administered (mL) 2.5 0.25 5 0.5 10 1 15 1.5 20 2 25 2.5 30 3 35 3.5 40 4 45 4.5 50 5 60 6 70 7 80 8 90 9 100 10 110 11 120 12 130 13 140 14 *for Cardiac MRI, the dose is divided into 2 separate, equal injections 2.2 Administration Guidelines • Gadobutrol injection is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Use Table 1 to determine the volume to be administered. • Use sterile technique when preparing and administering gadobutrol injection. MRI of the Central Nervous System • Administer gadobutrol injection as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/second. • Follow gadobutrol injection with a normal saline flush to ensure complete administration of the contrast. • Post contrast MRI can commence immediately following contrast administration.

• Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have occurred. Monitor patients closely during and after administration of gadobutrol injection. ( 5.3 ) • Acute Respiratory Distress Syndrome: For Patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function. ( 5.4 ) • Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.5 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Gadobutrol injection have not been established with intrathecal use. Gadobutrol injection is not approved for intrathecal use [see Dosage and Administration ( 2.2 )] . 5.2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of gadobutrol injection among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ) as well as patients with acute kidney injury.

The following clinically significant adverse reactions are discussed elsewhere in labeling: • Nephrogenic Systemic Fibrosis (NSF) [see Boxed Warning and Warnings and Precautions ( 5.2 )] . • Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] . • Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.4 )] . • Gadolinium Retention [see Warnings and Precautions ( 5.5 )] . Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse reactions described in this section reflect gadobutrol injection exposure in 7,713 subjects (including 184 pediatric patients, ages 0 to 17 years) with the majority receiving the recommended dose. Approximately 52% of the subjects were male and the ethnic distribution was 62% Caucasian, 28% Asian, 5% Hispanic, 2.5% Black, and 2.5% patients of other ethnic groups. The average age was 56 years (range from 1 week to 93 years). Overall, approximately 4% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after gadobutrol injection administration.

Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 ) 8.1 Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data ) . In animal reproduction studies, although teratogenicity was not observed, embryolethality was observed in monkeys, rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 times and above the recommended human dose. Retardation of embryonal development was observed in rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 and 12 times, respectively, the recommended human dose (see Data ). Because of the potential risks of gadolinium to the fetus, use gadobutrol injection only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and is 15% to 20%, respectively. Data Human Data Contrast enhancement is visualized in the placenta and fetal tissues after maternal GBCA administration.

Metabolism

Distribution After intravenous administration, gadobutrol is rapidly distributed in the extracellular space. After a gadobutrol dose of 0.1 mmol/kg body weight, an average level of 0.59 mmol gadobutrol/L was measured in plasma 2 minutes after the injection and 0.3 mmol gadobutrol/L 60 minutes after the injection.

The maximum dose of gadobutrol injection tested in healthy volunteers, 1.5 mL/kg body weight (1.5 mmol/kg; 15 times the recommended dose), was tolerated in a manner similar to lower doses. Gadobutrol can be removed by hemodialysis [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .

• Mar 14, 2011NDANDA201277Bayer Hlthcare
• Nov 17, 2022ANDAANDA215061Hengrui Pharma
• Mar 15, 2023ANDAANDA217480Hainan Poly Pharm
• Sep 8, 2023ANDAANDA216081Hengrui Pharma

1. 1Urticaria1,16224%
2. 2Nausea87618%
3. 3Vomiting73315%
4. 4Pruritus71115%
5. 5Dyspnoea4479.3%
6. 6Erythema3687.7%
7. 7Dizziness2405.0%
8. 8Rash2375.0%
9. 9Cough2244.7%
10. 10Headache2174.5%
11. 11Throat Irritation1803.8%
12. 12Contrast Media Reaction1673.5%
13. 13Feeling Hot1402.9%
14. 14Anaphylactic Reaction1392.9%
15. 15Sneezing1392.9%

The 10 most recently updated of 112 ClinicalTrials.gov registrations naming Gadobutrol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
  Recruiting · Interventional · 1,000 enrolled · Brigham and Women's Hospital
  NCT06854458updated 2026-06-03
• PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
  Active not recruiting · Early phase 1 · Interventional · 25 enrolled · M.D. Anderson Cancer Center
  NCT04219904updated 2026-05-20
• A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
  Recruiting · Phase 2 · Phase 3 · Interventional · 640 enrolled · GE Healthcare
  NCT07472491updated 2026-05-18
• A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions
  Active not recruiting · Phase 3 · Interventional · 309 enrolled · Shanghai Shengdi Pharmaceutical Co., Ltd
  NCT07275723updated 2026-05-11
• Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
  Completed · Interventional · 293 enrolled · AB-CT - Advanced Breast-CT GmbH
  NCT05989022updated 2026-05-07
• Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)
  Recruiting · Phase 4 · Interventional · 10 enrolled · UConn Health
  NCT06846853updated 2026-04-28
• Investigational MRI Clinical Software and Hardware
  Recruiting · Phase 4 · Interventional · 2,000 enrolled · Northwestern University
  NCT05215132updated 2026-04-24
• Quantitative Analysis of Cardiac Muscle Perfusion
  Not yet recruiting · Interventional · 35 enrolled · St. Anne's University Hospital Brno, Czech Republic
  NCT07548879updated 2026-04-23
• A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions
  Recruiting · Phase 3 · Interventional · 250 enrolled · Shanghai Shengdi Pharmaceutical Co., Ltd
  NCT07275814updated 2026-04-21
• Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance
  Completed · Interventional · 120 enrolled · The Methodist Hospital Research Institute
  NCT03057561updated 2026-04-20

Frequently asked questions

How does Gadobutrol work?

In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: • Differences in proton density • Differences of the spin-lattice or longitudinal relaxation times (T 1 ) • Differences in the spin-spin or transverse relaxation time (T 2 ) When placed in a magnetic field, gadobutrol shortens the T 1 and T 2 relaxation times. The extent of decrease of T 1 and T 2 relaxation times, and therefore the amount of signal enhancement obtained from gadobutrol, is based upon several factors including the concentration of gadobutrol in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times.

What is Gadobutrol used for?

According to FDA labeling, Gadobutrol carries indications including: Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates ( 1.1 ) • To assess the presence and extent of malignant breast disease in adult patients ( 1.2 ) • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates ( 1.3 ) • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). ( 1.4 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gadobutrol?

Gadobutrol is classified as Paramagnetic contrast media, Gadolinium-based Contrast Agent, Magnetic Resonance Contrast Activity.

What are the contraindications for Gadobutrol?

Gadobutrol labeling lists contraindications including: Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection.. Always consult the full prescribing information and a clinician.