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Optimal Diagnostic Imaging
Case 1
65-year-old man – 3.0 T Siemens
Brain metastasis from lung adenocarcinoma¹
Pre T1 SE
Post T1 SE
Post T1 SE
SE = Spin Echo.
These are representative images from reference studies; individual results may vary.
Case 2
66-year-old man
Brain metastases from unknown primary cancer¹
Gadopiclenol
Gadobutrol
Gadopiclenol
Gadobutrol
Pre T1 SE
Post T1 SE
Pre T1 GRE
Post T1 GRE
SE = Spin Echo. GRE = Gradient Echo
These are representative images from reference studies; individual results may vary.
Case 3
62-year-old woman
Right frontal high-grade glial tumor¹
Pre T1 SE
Post T1 SE
Post T1 SE
SE = Spin Echo.
These are representative images from reference studies; individual results may vary.
Case 4
61-year-old man
Cholangiocarcinoma²
Gadopiclenol
Gadobutrol
Gadopiclenol
Gadobutrol
Arterial Phase
These are representative images from reference studies; individual results may vary.
Case 5
66-year-old man
Cirrhotic patient with hepatocellular carcinoma (HCC)²
Gadopiclenol
Gadobutrol
Gadopiclenol
Gadobutrol
Early Arterial Phase
Late Arterial Phase
Delayed Phase
These are representative images from reference studies; individual results may vary.
Case 6
61-year-old man
Right kidney cancer & pancreatic metastasis²
Gadopiclenol
Gadobutrol
Gadopiclenol
Gadobutrol
Arterial Phase
Venous Phase
Late Phase
These are representative images from reference studies; individual results may vary.
Case 7
44-year-old woman
Right breast cancer with breast implants²
Gadopiclenol
(subtracted)
(subtracted)
(MIP)
(MIP)
Gadobutrol
Gadopiclenol
Gadobutrol
1st dynamic (subtracted)
3rd dynamic (subtracted)
1st dynamic (MIP)
3rd dynamic (MIP)
These are representative images from reference studies; individual results may vary.
Case 8
34-year-old woman – 3.0 T Philips
Fibroadenoma in right breast & multicentric cancer in left breast²
Gadopiclenol
(subtracted)
(subtracted)
(subtracted)
(subtracted)
Gadobutrol
Gadopiclenol
Gadobutrol
1st dynamic (subtracted)
3rd dynamic (subtracted)
1st dynamic (subtracted)
3rd dynamic (subtracted)
These are representative images from reference studies; individual results may vary.
Case 9
39-year-old woman
Glial malignant lesion³
Gadopiclenol
0.05 mmol/kg
Gadobenate
Dimeglumine
0.1 mmol/kg
Gadopiclenol
0.05 mmol/kg
Gadobenate
Dimeglumine
0.1 mmol/kg
Pre T1 SE
Post T1 SE
SE = Spin Echo.
These are representative images from reference studies; individual results may vary.
Case 10
63-year-old woman
Brain metastasis from lung cancer³
Gadopiclenol
0.05 mmol/kg
Gadobenate
Dimeglumine
0.1 mmol/kg
Gadopiclenol
0.05 mmol/kg
Gadobenate
Dimeglumine
0.1 mmol/kg
Pre T1 SE
Post T1 SE
SE = Spin Echo.
These are representative images from reference studies; individual results may vary.
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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 surrounding 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%).
MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL and MultiHance® Multipack™ (gadobenate dimeglumine) injection, 529 mg/mL
Indications and Usage:
MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL is a gadolinium-based contrast agent indicated for intravenous use in:
- 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
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. MultiHance 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 MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
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%).
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.
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 Prescribing Information and Patient Medication Guide for additional important safety information for/regarding MultiHance (gadobenate dimeglumine) injection, 529 mg/mL.
Please click here for Prescribing Information and Patient Medication Guide for additional important safety information for/regarding MultiHance 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.
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.
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.
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.
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 surrounding 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%).
MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL and MultiHance® Multipack™ (gadobenate dimeglumine) injection, 529 mg/mL
Indications and Usage:
MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL is a gadolinium-based contrast agent indicated for intravenous use in:
- 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
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. MultiHance 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 MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
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%).
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.
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 Prescribing Information and Patient Medication Guide for additional important safety information for/regarding MultiHance (gadobenate dimeglumine) injection, 529 mg/mL.
Please click here for Prescribing Information and Patient Medication Guide for additional important safety information for/regarding MultiHance 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.
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.
