Clinical Data:
Efficacy & Safety

The individual who appears is for illustrative purposes. The person depicted is a model and not a real healthcare professional.

Gadopiclenol is a unique GBCA with the highest relaxivity and highest kinetic stability* of all GBCAs today.1,2

*Kinetic stability describes the speed of in vivo complex dissociation of gadolinium, or propensity to release Gd ions following transmetallation in vivo (in addition to thermodynamic stability).

 

Gadopiclenol:

The highest relaxivity of all GBCAs today2

Gadopiclenol demonstrates 2- to 3-fold higher relaxivity than current linear and macrocyclic GBCAs at all field strengths of MRI scanners.1-6

Charts based on Robic C et al. Invest Radiol 2019

With high relaxivity maintained at all evaluated field strengths, VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL offers versatility across different diagnostic imaging scenarios, including:

Low-field magnets
Abbreviated exams
High-field magnets
All scanner types
Ongoing monitoring
All scanner types
Ongoing monitoring

No Compromise in CNS: Efficacy at a lower dose

Less Gd needed in neuroimaging1,7,8*

The approved dose of VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL is half the administered Gd of other macrocyclic GBCAs in approved indications in the U.S.1

*At 0.05 mmol/kg, Gadopiclenol is approved at the half the gadolinium compared to other macrocyclic GBCAs in approved indications in the U.S.1,3,4,6,9
All images shown are representative images from referenced studies. Individual results may vary.​

Clinical case from the dose‑finding study of VUEWAY® injection: 65-year-old female patient with brain metastasis from lung cancer. A similar level of contrast enhancement, lesion border delineation, and visualization of lesion internal morphology were obtained with 0.05 mmol/kg VUEWAY Injection (left) vs. 0.1 mmol/kg MultiHance® (right).10

No Compromise in body imaging

Half the dose, similar results1,11

VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL provides non-inferior, at least comparable contrast enhancement at half the gadolinium dose (0.05 mmol/kg) vs. a macrocyclic GBCA at a dose of 0.1 mmol/kg.1,11

Two pivotal phase III studies were conducted in adult patients undergoing MRI with both VUEWAY injection at 0.05 mmol/kg and Gadavist® (gadobutrol) at 0.1 mmol/kg for examination.1,11

No Compromise: Established safety profile1,10,12

Safety is an important consideration in the selection of contrast media.

Established safety in adults and children1,7,10,13

  • No safety differences in type of adverse events were observed in 8 clinical studies compared with other approved GBCAs during the clinical development of VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL:†
    • Involving 1047 subjects: 967 adults, 80 pediatric patients (2 years and older).1
    • †Compared to Gadavist® (gadobutrol) and MultiHance® (gadobenate dimeglumine).
  • Adults were exposed to doses ranging from 0.025 to 0.3 mmol/kg; pediatric patients to 0.05 mmol/kg.
  • VUEWAY Injection at 0.05 mmol/kg is well tolerated in patients aged 2 to 17 years.12
    • Prospective, multicenter, open-label study: 80 patients in three sequential groups by age: 12-17, 7-11, and 2-6 years.

Most common AEs for VUEWAY Injection were headache and injection-site pain (most AEs mild in intensity).1

  • No differences related to age, sex, race1
  • No effects on QT interval / ventricular repolarization14
VUEWAY has been classified by the American College of Radiology ACR as a Group Il Agent*

“…the risk of NSF among patients exposed to standard or lower than
standard doses of gadopiclenol is sufficiently low or possibly nonexistent
such that it has been classified as a Group II agent.”15

—ACR: 2023 position statement on GBCAs

 

Group II: Agents associated with few, if any, unconfounded cases of NSF15
See the ACR Manual on Contrast Media
*ACR classifies Group II Agents as those with few, if any, medically confirmed unconfounded cases of NSF.

No Compromise: A GBCA to help simplify workflow

Gadopiclenol

The largest number of approved MRI indications to detect and visualize lesions:1

Central Nervous System

Brain, spine, and associated tissues

Body
  • Head and neck
  • ​Thorax
  • ​Abdomen
  • Pelvis
  • ​Musculoskeletal system
The individuals who appear are for illustrative purposes. All persons depicted are models and not real patients or healthcare professionals.
The individuals who appear are for illustrative purposes. All persons depicted are models and not real healthcare professionals.

VUEWAY® Injection1

Offers the efficiency of:

  • One contrast agent
  • ​One dosing regimen​
  • Adaptable to multiple procedures
  • Simplified inventory management
  • Simplified workflow

IMPORTANT SAFETY INFORMATION 

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. VUEWAY, MultiHance, and ProHance are not approved for intrathecal use.

VUEWAY® (gadopiclenol) solution for injection

Indications
VUEWAY injection is indicated in adults and children aged 2 years and older 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).

IMPORTANT SAFETY INFORMATION
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. VUEWAY is not approved for intrathecal use.

NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m²), or
    • Acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindications
VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY.

Warnings and Precautions
There are risks associated with intrathecal use of GBCAs that can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of VUEWAY have not been established with intrathecal use and VUEWAY is not approved for intrathecal use.

Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.

Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration.

Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible.

Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent.

Extravasation and injection site reactions can occur with administration of VUEWAY. Ensure catheter and venous patency before the injection of VUEWAY.

VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan.

The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%).

POST-MARKETING EVENTS
Acute pancreatitis within 48 hours of GBCA administration has been reported.

MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL
and
ProHance® (Gadoteridol) Injection, 279.3 mg/mL

Indications and Usage for MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL:

  • 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
  • Magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease

Indications and Usage for ProHance® (Gadoteridol) Injection, 279.3 mg/mL:
CENTRAL NERVOUS SYSTEM
ProHance is indicated for use in 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.

EXTRACRANIAL/EXTRASPINAL TISSUES
ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

IMPORTANT SAFETY INFORMATION for MultiHance and ProHance:
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. MultiHance and ProHance are not approved for intrathecal use.

NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • chronic, severe kidney disease (GFR < 30 mL/min/1.73m²), or
    • acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended MultiHance and ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

MultiHance (gadobenate dimeglumine) injection, 529 mg/mL

CONTRAINDICATIONS
MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents.

WARNINGS AND PRECAUTIONS
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 and MultiHance is not approved for intrathecal use.
Nephrogenic Systemic Fibrosis: NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase risk.
Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of MultiHance administration and resolved with prompt emergency treatment. Consider the risk for hypersensitivity reactions, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders.
Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver, and spleen. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.
Acute Renal Failure: In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred with the use of GBCAs. The risk of renal failure may increase with increasing dose of the contrast agent. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.
Extravasation and Injection Site Reactions: Extravasation of MultiHance may lead to injection site reactions, characterized by local pain or burning sensation, swelling, blistering, and necrosis. Exercise caution to avoid local extravasation during intravenous administration of MultiHance.
Cardiac Arrhythmias: Cardiac arrhythmias have been observed in patients receiving MultiHance in clinical trials. Assess patients for underlying conditions or medications that predispose to arrhythmias. The effects on QTc by MultiHance dose, other drugs, and medical conditions were not systematically studied.
Interference with Visualization of Certain Lesions: Certain lesions seen on non-contrast images may not be seen on contrast images. Exercise caution when interpreting contrast MR images in the absence of companion non-contrast MR images.

ADVERSE REACTIONS
The most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%).

POST-MARKETING EVENTS
Acute pancreatitis within 48 hours of GBCA administration has been reported.

USE IN SPECIFIC POPULATIONS
Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed.
Lactation: There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, limited literature reports that breastfeeding after MultiHance administration to the mother would result in the infant receiving an oral dose of 0.001%-0.04% of the maternal dose.
Pediatric Use: MultiHance is approved for intravenous use for MRI of the CNS to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to less than 17 years of age. Adverse reactions in pediatric patients were similar to those reported in adults. No dose adjustment according to age is necessary in pediatric patients two years of age and older. For pediatric patients, less than 2 years of age, the recommended dosage range is 0.1 to 0.2 mL/kg. The safety of MultiHance has not been established in preterm neonates.

ProHance (Gadoteridol) Injection, 279.3 mg/mL

CONTRAINDICATIONS
Contraindicated in patients with known allergic or hypersensitivity reactions to ProHance.

WARNINGS AND PRECAUTIONS
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 ProHance have not been established with intrathecal use and ProHance is not approved for intrathecal use.
Nephrogenic Systemic Fibrosis: NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase risk.
Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of administration and resolved with prompt emergency treatment. Prior to ProHance administration, ensure the availability of trained personnel and medications to treat hypersensitivity reactions. Consider these risks, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders.
Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver, and spleen. Linear GBCAs cause more retention than macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function.
Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging.

ADVERSE REACTIONS
The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9%.

POST-MARKETING EVENTS
Acute pancreatitis within 48 hours of GBCA administration has been reported.

USE IN SPECIFIC POPULATIONS
Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed.
Lactation: There are no data on the presence in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.
Pediatric Use: The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age. Adverse reactions in pediatric patients were similar to those reported in adults. No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information for VUEWAY (gadopiclenol) solution for injection including BOXED WARNING on Nephrogenic Systemic Fibrosis.

Please click here for full Prescribing Information and Patient Medication Guide for additional safety information for MultiHance (gadobenate dimeglumine) injection, 529 mg/mL.

Please click here for full Prescribing Information and Patient Medication Guide for additional safety information for MultiHance Multipack.

Please click here for full Prescribing Information and Patient Medication Guide for additional safety information for ProHance (Gadoteridol) Injection, 279.3 mg/mL.

Please click here for full Prescribing Information and Patient Medication Guide for additional safety information for ProHance Multipack.

VUEWAY is manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC - Raleigh, NC, USA 27616.

MultiHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany) and by Patheon Italia S.p.A, Ferentino, Italy.

ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany).

VUEWAY is a registered trademark of Bracco Imaging S.p.A.

MultiHance is a registered trademark of Bracco International B.V.

MultiHance Multipack is a trademark of Bracco International B.V.

ProHance is a registered trademark of Bracco Diagnostics Inc.

ProHance Multipack is a trademark of Bracco Diagnostics Inc.

All other trademarks and registered trademarks are the property of their respective owners.

References:

1. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.; July 2024.

2. Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol. 2019; 54: 475-484.

3. GADAVIST® (gadobutrol) Injection. Full Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ; April 2022.

4. ProHance® (Gadoteridol) Injection, 279.3 mg/mL Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.; August 2024.

5. MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.; August 2024.

6. DOTAREM® (gadoterate meglumine) Injection. Full Prescribing Information. Guerbet LLC. Princeton, NJ; April 2022.

7. Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and safety of gadopiclenol for contrast-enhanced MRI of the central nervous system: the PICTURE randomized clinical trial. Invest Radiol. 2023 May;58(5):307-313.

8. Groden C, Pichiecchio A, Kolumban B, et al. Efficacy and Safety Of Gadopiclenol For Central Nervous System (CNS) Magnetic Resonance Imaging (MRI): Results From The Phase III Picture Trial. Neuroradiology. 2022 Aug; 64 (Suppl 1):S113– S114 (ESNR 2022).

9. CLARISCAN™ (gadoterate meglumine) injection for intravenous use. Full Prescribing Information. GE Healthcare. Chicago, IL; November 2020.

10. Bendszus M, Roberts D, Kolumban B, et al. Dose Finding Study of Gadopiclenol, a New Macrocyclic Contrast Agent, in MRI of Central Nervous System. Invest Radiol. 2020 Mar;55(3):129-137.

11. Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology. 2023 Jul; 308(1): e222612.

12. Jurkiewicz E, Tsvetkova S, Grinberg A, Pasquiers B. Pharmacokinetics, safety, and efficacy of gadopiclenol in pediatric patients aged 2 to 17 years. Invest Radiol. 2022 Aug;57(8):510-516.

13. Hao J, Pitrou C, Bourrinet P. A comprehensive overview of the efficacy and safety of gadopiclenol: a new contrast agent for MRI of the CNS and body. Invest Radiol. 2024;59(2):124-130.

14. Funck-Brentano C, Felices M, Le Fur N, et al. Randomized study of the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval in healthy subjects. Br J Clin Pharmacol. 2020 Nov;86(11):2174-2181.

15. ACR Manual on Contrast Media, Updated 2024. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Accessed November 19, 2024.

IMPORTANT SAFETY INFORMATION | INDICATIONS AND USAGE

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. VUEWAY, MultiHance ,and ProHance are not approved for intrathecal use.