Gadoteridol

Gadoteridol is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent.

• Gadoteridol Injection is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates (1.1 ) lesions in the head and neck in adults ( 1.2 ) 1.1 MRI of the Central Nervous System (CNS) Gadoteridol Injection is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.2 MRI of Extracranial/Extraspinal Head and Neck Gadoteridol Injection is indicated for MRI in adults to visualize lesions in the head and neck.

• Gadoteridol Injection is contraindicated in patients with known allergic or hypersensitivity reactions to Gadoteridol Injection [see Warnings and Precautions ( 5.3 )] .contraindicated

Recommended dose in adult and pediatric patients is 0.2 mL/kg (0.1 mmol/kg) body weight administered as rapid intravenous infusion or bolus ( 2.1 ) Follow injection with a saline flush of at least 5 mL normal saline ( 2.1 ) 2.1 Recommended Dose The recommended dose for adult and pediatric patients, including term neonates, is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min). Table 1 provides weight-adjusted recommended dose volumes. Table 1: Recommended Volume of Gadoteridol Injection by Body Weight Body Weight (kg) Volume to be Administered (mL) 2.5 0.5 5 1 10 2 20 4 30 6 40 8 50 10 60 12 70 14 80 16 90 18 100 20 110 22 120 24 130 26 140 28 150 30 MRI of the CNS in Adults A supplementary dose of 0.4 mL/kg (0.2 mmol/kg) may be given up to 30 minutes after the first dose in adult patients with normal renal function suspected of having poorly visualized CNS lesions, in the presence of negative or equivocal scans The safety and efficacy of supplementary dosing have not been established in pediatric patients 2.2 Administration Visually inspect Gadoteridol Injection for particulate matter and discoloration prior to use Do not administer the solution if it is discolored or particulate matter is present Concurrent medications or parenteral nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility Inject at least a 5 mL normal saline flush immediately after Gadoteridol Injection to ensure…

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 Gadoteridol injection have not been established with intrathecal use. Gadoteridol injection 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 Gadoteridol 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 less than 30 mL/min/1.73 m 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/1.73 m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60 - 89 mL/min/1.73 m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: Nephrogenic systemic fibrosis [see Boxed Warning and Warnings and Precautions ( 5.2 )] . Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions (5.3 )] . The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9% ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 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. The adverse events described in this section were observed in clinical trials involving 3174 subjects (including 2896 adults and 278 pediatric subjects ages 0 to 17 years) exposed to Gadoteridol Injection. Approximately 48% of the subjects were men and ethnic distribution was 78% Caucasian, 6% Black, 3% Hispanic, 6% Asian, and 2% other. In 5% of the subjects, race was not reported. Average age was 47 years (range from 1 day to 91 years) and the exposure ranged from 0.03 to 0.3 mmol/kg. Overall, approximately 5.8% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after Gadoteridol 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 ) . Because of the potential risks of gadolinium to the fetus, use Gadoteridol Injection only if imaging is essential during pregnancy and cannot be delayed. In animal reproduction studies in rats, gadoteridol doubled the incidence of post-implantation loss at up to 16 times the recommended human dose (RHD). There were no adverse developmental effects observed in rabbits with intravenous administration of gadoteridol during organogenesis at doses up to 19 times the recommended human dose of 0.1 mmol/kg (see Data ) . 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 agent is visualized in the placenta and fetal tissues after maternal GBCA administration.

Metabolism

The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two-compartment open model. Distribution After intravenous administration, gadoteridol is rapidly distributed in the extracellular space.

Clinical consequences of overdose with Gadoteridol Injection have not been reported. The safety of Gadoteridol Injection has been tested in clinical studies using doses up to 0.3 mmol/kg and no clinical consequences related to increasing dose have been observed to date. Gadoteridol can be removed by hemodialysis [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )].

• Nov 16, 1992NDANDA020131Bracco
• Oct 9, 2003NDANDA021489Bracco
• Feb 11, 2025ANDAANDA218749Hainan Poly

1. 1Nephrogenic Systemic Fibrosis58533%
2. 2Pain40423%
3. 3Anxiety25414%
4. 4Emotional Distress22313%
5. 5Mobility Decreased18611%
6. 6General Physical Health Deterioration18410%
7. 7Fibrosis18310%
8. 8Injury17810%
9. 9Scar1599.0%
10. 10Skin Hypertrophy1548.7%
11. 11Skin Induration1518.6%
12. 12Pruritus1407.9%
13. 13Skin Tightness1377.8%
14. 14Dyspnoea1367.7%
15. 15Nausea1257.1%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Gadoteridol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
  Recruiting · Early phase 1 · Interventional · 20 enrolled · University of Alabama at Birmingham
  NCT04861077updated 2026-06-02
• 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
• A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)
  Completed · Phase 3 · Interventional · 404 enrolled · Bayer
  NCT05915728updated 2025-12-22
• Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
  Active not recruiting · Phase 2 · Interventional · 129 enrolled · Sanofi
  NCT04879628updated 2025-09-30
• Intraventricular Stasis In Cardiovascular Disease
  Completed · Observational · 258 enrolled · Hospital General Universitario Gregorio Marañon
  NCT04649034updated 2025-09-15
• A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems
  Completed · Phase 3 · Interventional · 303 enrolled · Bayer
  NCT05915702updated 2025-08-17
• Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases
  Completed · Interventional · 25 enrolled · Duke University
  NCT04248543updated 2025-07-16
• Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis
  Completed · Observational · 24 enrolled · University of Maryland, Baltimore
  NCT03396822updated 2024-02-28
• Novel Imaging Markers in SPMS
  Completed · Early phase 1 · Interventional · 11 enrolled · University of Utah
  NCT05357833updated 2023-09-26
• Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection
  Terminated · Phase 1 · Interventional · 7 enrolled · OncoSynergy, Inc.
  NCT04608812updated 2023-08-18

Frequently asked questions

How does Gadoteridol work?

Gadoteridol is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent.

What is Gadoteridol used for?

According to FDA labeling, Gadoteridol carries indications including: Gadoteridol Injection is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates (1.1 ) lesions in the head and neck in adults ( 1.2 ) 1.1 MRI of the Central Nervous System (CNS) Gadoteridol Injection is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.2 MRI of Extracranial/Extraspinal Head and Neck Gadoteridol Injection is indicated for MRI in adults to visualize lesions in the head and neck.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gadoteridol?

Gadoteridol is classified as Paramagnetic contrast media, Paramagnetic Contrast Agent, Magnetic Resonance Contrast Activity.

What are the contraindications for Gadoteridol?

Gadoteridol labeling lists contraindications including: Gadoteridol Injection is contraindicated in patients with known allergic or hypersensitivity reactions to Gadoteridol Injection [see Warnings and Precautions ( 5.3 )] .. Always consult the full prescribing information and a clinician.