Gadopiclenol

Gadopiclenol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.

• Vueway ® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) Vueway is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) ( 1 )

• Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway.contraindicated

The recommended dose for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of Vueway for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously. 2.2 Administration and Imaging Instructions Administer Vueway as an intravenous bolus injection, manually or by compatible power injector, at approximately 2 mL/sec followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. Use aseptic technique for all handling and administration of Vueway. Visually inspect Vueway for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility. Prime intravenous line before use. Contrast MRI can begin immediately following the injection of Vueway. 2.3 Directions for Use of Single-Dose Vial and Pre-filled Syringe Vial Pierce the rubber stopper only once. Aseptically draw up Vueway into a disposable syringe and use immediately. If solidification occurs in the vial due to cold exposure, bring the vial of Vueway to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration. Discard any unused portion.

Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with GBCAs. Monitor patients closely for need of emergency cardiorespiratory support. ( 5.3 ) Gadolinium Retention: 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 Vueway have not been established with intrathecal use. Vueway 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 Vueway 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/1.73 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. Report any diagnosis of NSF following Vueway administration to Bracco Diagnostics Inc. (1-800-257-5181) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch ).

The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema. ( 6.1 ) 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 clinical practice. The safety of Vueway was evaluated in 1,083 patients who received Vueway at doses ranging from 0.025 mmol/kg (one half the recommended dose) to 0.3 mmol/kg (six times the recommended dose). A total of 744 patients (including 116 pediatric patients) received the recommended dose of 0.05 mmol/kg. Among patients who received the recommended dose, the average age was 49 years (range from less than one month to 88 years) and 55% were female. The race distribution was 80% White, 10% Asian, 6% American Indian or Alaska native, 2% Black, and 2% patients of other or unspecified race groups. Overall, approximately 4.6% of subjects receiving the labeled dose reported one or more adverse reactions.

Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 ) 8.1 Pregnancy Risk Summary There are no available data on Vueway use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. GBCAs cross the placenta and result in fetal exposure. In human placental imaging studies, contrast was visualized in the placenta and fetal tissues after maternal GBCA administration. Based on animal studies, use of GBCAs during pregnancy may result in fetal gadolinium retention. Published epidemiological studies on the association between GBCAs and adverse fetal outcomes have reported inconsistent findings and have important methodological limitations (see Data ) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of Vueway during organogenesis (see Data ) . Because of the potential risks of gadolinium to the fetus, use Vueway only if imaging is essential during pregnancy and cannot be delayed. The background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

The C max and AUC inf of gadopiclenol increased proportionally over a dosage range from 0.025 mmol/kg to 0.3 mmol/kg (0.5 times to 6 times the recommended dosage). At the recommended dose, the mean (CV%) C max and AUC inf were 525 (13%) µg/mL and 569 (18%) µg•h/mL, respectively.

Among subjects who received a single 0.3 mmol/kg intravenous dose of gadopiclenol (6 times the recommended dose of Vueway), headache and nausea were the most frequently reported adverse reactions. Gadopiclenol can be removed from the body by hemodialysis [see Clinical Pharmacology ( 12.3 )] .

• Sep 21, 2022NDANDA216986Guerbet

1. 1Urticaria5124%
2. 2Pruritus3517%
3. 3Nausea3215%
4. 4Vomiting2512%
5. 5Rash188.6%
6. 6Dyspnoea146.7%
7. 7Erythema146.7%
8. 8Hypersensitivity146.7%
9. 9Dizziness115.2%
10. 10Anaphylactic Reaction104.8%
11. 11Contrast Media Reaction104.8%
12. 12Sneezing94.3%
13. 13Cough83.8%
14. 14Paraesthesia83.8%
15. 15Throat Tightness83.8%

The 10 most recently updated of 25 ClinicalTrials.gov registrations naming Gadopiclenol 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
• ELUDYN: Assessment of Intra-individual Variability of Vascular Dynamics of Gadopiclenol Injection Parameters in Contrast-enhanced MRI
  Active not recruiting · Phase 4 · Interventional · 14 enrolled · Hôpital Fribourgeois
  NCT07346131updated 2026-04-29
• Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)
  Recruiting · Phase 4 · Interventional · 10 enrolled · UConn Health
  NCT06846853updated 2026-04-28
• Gadopiclenol vs Gadoxetate MRI for Liver Lesions
  Enrolling by invitation · Observational · 23 enrolled · Icahn School of Medicine at Mount Sinai
  NCT06596616updated 2026-04-22
• Guerbet Liver Fibrosis
  Enrolling by invitation · Observational · 50 enrolled · Icahn School of Medicine at Mount Sinai
  NCT06703450updated 2026-04-21
• Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
  Not yet recruiting · Interventional · 40 enrolled · M.D. Anderson Cancer Center
  NCT07415018updated 2026-04-14
• High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
  Recruiting · Phase 4 · Interventional · 25 enrolled · Johns Hopkins University
  NCT05954559updated 2026-04-13
• Screening for Brain Metastases
  Not yet recruiting · Phase 2 · Interventional · 180 enrolled · University of Zurich
  NCT07492121updated 2026-03-25
• Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas
  Completed · Phase 3 · Interventional · 138 enrolled · Guerbet
  NCT06057168updated 2026-01-29
• Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease
  Not yet recruiting · Phase 3 · Interventional · 315 enrolled · Guerbet
  NCT07348640updated 2026-01-20

Frequently asked questions

How does Gadopiclenol work?

Gadopiclenol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.

What is Gadopiclenol used for?

According to FDA labeling, Gadopiclenol carries indications including: Vueway ® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) Vueway is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) ( 1 ). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gadopiclenol?

Gadopiclenol is classified as Paramagnetic contrast media, Imaging Contrast Activity, Magnetic Resonance Contrast Activity.

What are the contraindications for Gadopiclenol?

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