Gadobenate

Gadobenate dimeglumine is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The large magnetic moment produced by the paramagnetic agent results in a large local magnetic field, which can enhance the relaxation rates of water protons in its vicinity leading to an increase of signal intensity (brightness) of tissue.

• magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. (1.1) magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.

• MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents [ see Warnings and Precautions (5.3) ]. MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents.contraindicated

The recommended dose of MultiHance is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection. For MRI of the CNS in pediatric patients below 2 years of age the recommended dosage range is 0.1 to 0.2 mL/kg. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL in MRI of the CNS and at least 20 mL in MRA. ( 2 ) 2.1 Dosing and Imaging Instructions 2.1.1 MRI of the CNS In adults and in pediatric patients over 2 years of age, the recommended dose of MultiHance for MRI of the CNS is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection. In pediatric patients below 2 years of age, the recommended dosage range is 0.1 to 0.2 mL/kg administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance. 2.1.2 MRA of Renal and Aorto-ilio-femoral Vessels For MRA examination, the recommended dose is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.

Hypersensitivity: anaphylactic/anaphylactoid reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur. Monitor patients closely for need of emergency cardiorespiratory support. (5.3) Gadolinium is retained for months or years in brain, bone, and other organs. (5.4) 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 MultiHance have not been established with intrathecal use. MultiHance is not approved for intrathecal use [see Dosage and Administration (2.1) ] . 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 MultiHance among these patients unless the diagnostic information is essential and not available with non-contrast enhanced 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 risk appears lower for patients with chronic, moderate kidney disease (GFR 30-59 mL/min/1.73m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60-89 mL/min/1.73m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The following adverse reactions are discussed in greater detail in other sections of the label: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] The most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%). (6) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-5181 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 practice. Adults In clinical trials with MultiHance, a total of 4967 adult subjects (137 healthy volunteers and 4830 patients) received MultiHance at doses ranging from 0.005 to 0.4 mmol/kg. There were 2838 (57%) men and 2129 (43%) women with a mean age of 56.5 years (range 18 to 93 years). A total of 4403 (89%) subjects were Caucasian, 134 (3%) Black, 275 (6%) Asian, 40 (1%) Hispanic, 70 (1%) in other racial groups, and for 45 (1%) subjects, race was not reported. The most commonly reported adverse reactions in adult subjects who received MultiHance were nausea (1.3%) and headache (1.2%). Most adverse reactions were mild to moderate in intensity. One subject experienced a serious anaphylactoid reaction with laryngeal spasm and dyspnea [ see Warnings and Precautions (5.3) ].

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, gadobenate dimeglumine has been shown to be teratogenic in rabbits following repeated intravenous administration during organogenesis at doses up to 6 times the recommended human dose. There were no adverse developmental effects observed in rats with intravenous administration of gadobenate dimeglumine during organogenesis at doses up to three times the recommended human dose (see Data ). Because of the potential risks of gadolinium to the fetus, use MultiHance only if imaging is essential and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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

Three single-dose intravenous studies were conducted in 32 healthy male subjects to assess the pharmacokinetics of gadobenate dimeglumine. The doses administered in these studies ranged from 0.005 to 0.4 mmol/kg.

Clinical consequences of overdosage with MultiHance have not been reported. Treatment of an overdosage should be directed toward support of vital functions and prompt institution of symptomatic therapy. In a Phase 1 clinical study, doses up to 0.4 mmol/kg were administered to patients. MultiHance has been shown to be dialyzable [ see Clinical Pharmacology (12.3) ].

• Nov 23, 2004NDANDA021357Bracco
• Nov 23, 2004NDANDA021358Bracco

1. 1Pain62214%
2. 2Nausea59214%
3. 3Nephrogenic Systemic Fibrosis58814%
4. 4Vomiting50212%
5. 5Hypersensitivity43510%
6. 6Urticaria4109.4%
7. 7Anxiety3838.8%
8. 8Injury3568.2%
9. 9Dyspnoea3528.1%
10. 10Emotional Distress3377.8%
11. 11Pruritus3237.4%
12. 12Arthralgia2936.7%
13. 13Burning Sensation2716.2%
14. 14Mobility Decreased2646.1%
15. 15Paraesthesia2626.0%

The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Gadobenate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of 18F-FFNP Breast PET/MRI
  Recruiting · Phase 2 · Interventional · 53 enrolled · University of Wisconsin, Madison
  NCT06086704updated 2026-05-18
• Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases
  Terminated · Phase 4 · Interventional · 10 enrolled · University of Colorado, Denver
  NCT04973007updated 2026-04-22
• Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
  Recruiting · Phase 4 · Interventional · 2,076 enrolled · Guerbet
  NCT04373564updated 2026-01-22
• PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Northwestern University
  NCT04910425updated 2025-10-21
• Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
  Completed · Phase 2 · Interventional · 12 enrolled · University of Wisconsin, Madison
  NCT03703492updated 2025-02-12
• Gadolinium Retention in Human Bone Tissue in Pediatric Patients
  Completed · Observational · 57 enrolled · Donna Roberts
  NCT03337594updated 2024-12-12
• Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics
  Unknown · Phase 3 · Interventional · 160 enrolled · University of California, San Diego
  NCT06406517updated 2024-05-09
• Comparison of Contrast Agents for MRI Perfusion Analysis in Brain Tumor Patients
  Terminated · Observational · 6 enrolled · University of Nebraska
  NCT02095353updated 2023-08-23
• Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
  Completed · Interventional · 6 enrolled · M.D. Anderson Cancer Center
  NCT04132843updated 2022-11-21
• P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
  Completed · Phase 2 · Interventional · 312 enrolled · Guerbet
  NCT02633501updated 2021-10-25

Frequently asked questions

How does Gadobenate work?

Gadobenate dimeglumine is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The large magnetic moment produced by the paramagnetic agent results in a large local magnetic field, which can enhance the relaxation rates of water protons in its vicinity leading to an increase of signal intensity (brightness) of tissue.

What is Gadobenate used for?

According to FDA labeling, Gadobenate carries indications including: magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. (1.1) magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gadobenate?

Gadobenate is classified as Magnetic Resonance Contrast Activity.

What are the contraindications for Gadobenate?

Gadobenate labeling lists contraindications including: MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents [ see Warnings and Precautions (5.3) ]. MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents.. Always consult the full prescribing information and a clinician.