GADAVIST® (gadobutrol) injection

Frequently asked questions about GADAVIST®

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What is the indication for GADAVIST?

GADAVIST is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

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What is the recommended dose in adults and children (2 years of age and older), and how should GADAVIST be administered?

The recommended dose of GADAVIST is 0.1 mL/kg body weight (0.1 mmol/kg).

Volume of GADAVIST injection by body weight. Kilogram dosing with GADAVIST is easy. Move the decimal, that's the dose.

  • Visually inspect GADAVIST for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.
  • Administer GADAVIST as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second. Flush the intravenous cannula with physiological saline solution after the injection.

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How does the volume administered of GADAVIST compare to 0.5 molar GBCAs?

GADAVIST is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration.

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How many GADAVIST-enhanced procedures have been performed worldwide since launch?

There have been over 14 million GADAVIST-enhanced procedures worldwide since its launch in Switzerland in 1998.

Estimated worldwide GADAVIST-enhanced procedures¹*

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What is the relaxivity of GADAVIST and other gadolinium-based contrast agents approved for CNS imaging?

Relaxivity of GADAVIST and other gadolinium-based contrast agents approved for CNS imaging

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What are the structural classes of Gd-chelate complexes?

There are two structural classes of Gd-chelate complexes: macrocyclic and linear. The GADAVIST macrocyclic chelate binds the Gd3+ ion in a cage. The molecular structures of both Gd-chelate complexes are shown below:

Structural classes of GBCA

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Which gadolinium-based contrast agents approved for CNS imaging are linear and which are macrocyclic?

The structures of GBCA approved for CNS imaging are as following:

Structures of GBCA approved for CNS imaging

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What are the contraindications, warnings and precautions for GADAVIST?

Nephrogenic Systemic Fibrosis
GADAVIST has a boxed warning for nephrogenic systemic fibrosis (NSF). Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs 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/1.73m2) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 3059 mL/min/1.73m2) and little, if any, for patients with chronic, mild kidney disease (GFR 6089 mL/min/1.73m2). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following GADAVIST administration to Bayer Healthcare (1-888-842-2937) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).

Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (for example, age >60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.

Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA anddegree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown [see Clinical Pharmacology (12) and Dosage and Administration (2)].

Contraindication and Hypersensitivity Reactions
GADAVIST is contraindicated in patients with history of severe hypersensitivity reactions to GADAVIST. Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following GADAVIST administration [see Adverse Reactions (6)].

  • Before GADAVIST administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to GADAVIST.
  • Administer GADAVIST only in situations where trained personnel and therapies are promptly available for treatment of hypersensitivity reactions, including personnel trained in resuscitation.

Most hypersensitivity reactions to GADAVIST have occurred within half an hour after administration. Delayed reactions can occur up to several days after administration. Observe patients for signs and symptoms of hypersensitivity reactions during and following GADAVIST administration.

Acute Kidney Injury
In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

Extravasation and Injection Site Reactions
Ensure catheter and venus patency before the injection of GADAVIST. Extravasation into tissues during GADAVIST administration may result in moderate irritation. Avoid intramuscular administration of GADAVIST [see Nonclinical Toxicology (13.2)].

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What adverse events were reported in GADAVIST clinical trials?

In 34 clinical trials of 4,549 patients worldwide, GADAVIST established the following safety profile:

Reaction rate(%) n=4549

  • Adverse reactions that occurred with a frequency of <0.1% in subjects who received GADAVIST include: hypersensitivity/anaphylactoid reactions (hypotension, urticarial, flushing, pallor), loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise and feeling cold.

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INDICATIONS and IMPORTANT SAFETY INFORMATION

GADAVIST (gadobutrol) Injection

INDICATIONS AND USAGE

Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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 of 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 (for example, 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 GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindication and Important Information about Hypersensitivity Reactions: Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Patients with any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders may have an increased risk for a hypersensitivity reaction to Gadavist®.

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation. Avoid intramuscular administration of Gadavist®.

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.5%), nausea (1.2%), injection site reaction (0.6%), dysgeusia (0.5%) and feeling hot (0.5%).

Please see full prescribing information.

EOVIST (gadoxetate disodium) Injection

INDICATIONS AND USAGE

Eovist® (gadoxetate disodium) injection is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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/1.73m2), 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 (for example, 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 EOVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindication and Important Information about Hypersensitivity Reactions: Eovist® is contraindicated in patients with history of severe hypersensitivity reactions to Eovist®. Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions, including shock have uncommonly occurred following Eovist® administration. Patients with any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders may have an increased risk for a hypersensitivity reaction to Eovist®.

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. The risk of acute kidney injury might be lower with Eovist® due to its dual excretory pathways. Do not exceed the recommended dose.

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Eovist®. Extravasation into tissues during Eovist® administration may result in local tissue reactions. Strictly avoid intramuscular administration of Eovist® because it may cause myocyte necrosis and inflammation.

Interference with Laboratory Tests: Serum iron determination using complexometric method (for example, Ferrocine complexation method) may result in falsely high or low values for up to 24 hours after Eovist® administration.

Interference with Visualization of Liver Lesions: Severe renal or hepatic failure may impair Eovist® imaging performance. In patients with end-stage renal failure, hepatic contrast was markedly reduced and attributed to elevated serum ferritin levels. In patients with abnormally high (>3 mg/dL) serum bilirubin, reduced hepatic contrast was observed. If Eovist® is used in these patients, complete MR imaging no later than 60 minutes after Eovist® administration and use a paired non-contrast and contrast MRI set for diagnosis.

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Eovist® are nausea (1.1%), headache (1.1%), feeling hot (0.8%), dizziness (0.6%), and back pain (0.6%).

Please see full prescribing information.

MAGNEVIST (gadopentetate dimeglumine) Injection

INDICATIONS AND USAGE

Central Nervous System: Magnevist® (gadopentetate dimeglumine) injection is indicated for the use with magnetic resonance imaging (MRI) in adults and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. Magnevist® has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.

Extracranial/Extraspinal Tissues: Magnevist® is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the head and neck.

Body: Magnevist® is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the body (excluding the heart).

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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.

  • Do not administer MAGNEVIST to 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 (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

Do not exceed the recommended MAGNEVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

Contraindications:

Magnevist® is contraindicated in patients with:

  • Chronic, severe kidney disease (glomerular filtration rate, GFR <30 mL/min/1.73m2),or
  • Acute kidney injury, or
  • History of severe hypersensitivity reactions to Magnevist®.

Hypersensitivity Reactions: Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory and/or cutaneous manifestations rarely resulting in death have occurred. The risk of hypersensitivity reactions is higher in patients with a history of reaction to contrast media, bronchial asthma, or allergic disorders. Hypersensitivity reactions can occur with or without prior exposure to GBCAs.

Renal Failure: In patients with renal impairment, acute renal failure (acute kidney injury) requiring dialysis or worsening renal function has occurred, mostly within 48 hours of Magnevist® Injection. The risk of acute renal failure is higher with increasing dose of contrast. Use the lowest possible dose, evaluate renal function in patients with renal impairment, and allow sufficient time for contrast elimination before re-administration. Elimination half-life in patients with mild or moderate renal impairment is 3 to 4 hours. Elimination half-life in patients with severe renal impairment is about 11 hours. Magnevist® is cleared by glomerular filtration and is dialyzable. After 3 dialysis sessions of 3 hours each, about 97% of the administered dose is eliminated from the body; each dialysis session removes about 70% of the circulating drug.

Injection Site Reaction: Skin and soft tissue necrosis, thrombosis, fasciitis, and compartment syndrome requiring surgical intervention (e.g., compartment release or amputation) have occurred very rarely at the site of the contrast injection or the dosed limb. Total volume and rate of Magnevist® Injection, extravasation of contrast agent, and patient susceptibility might contribute to these reactions. Phlebitis and thrombophlebitis may be observed generally within 24 hours after Magnevist® Injection and resolve with supportive treatment. Determine the patency and integrity of the intravenous line before administration of Magnevist® Injection. Assessment of the dosed limb for the development of injection site reactions is recommended.

Interference with Visualization of Lesions with Non-Contrast MRI: As with any paramagnetic contrast agent, Magnevist® Injection might impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when Magnevist® MRI scans are interpreted without a companion non-contrast MRI scan.

Adverse Reactions: In clinical trials, the most frequently reported adverse reactions (≥1%) included headache (4.8%), nausea (2.7%), injection site coldness/localized coldness (2.3%) and dizziness (1%).

Please see full prescribing information.

ULTRAVIST® (iopromide) Injection

INDICATIONS AND USAGE

Ultravist® (iopromide) Injection is an iodinated contrast agent indicated for:

Intra-arterial Procedures*: 300 mg I/mL for cerebral arteriography and peripheral arteriography; 370 mg I/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography.

Intravenous Procedures*: 240 mg I/mL for peripheral venography; 300 mg I/mL for excretory urography; 300 mg I/mL and 370 mg I/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intraabdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.

* For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4) in the full prescribing information].

IMPORTANT SAFETY INFORMATION

WARNING: NOT FOR INTRATHECAL USE

Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

CONTRAINDICATIONS

Ultravist Injection is contraindicated for intrathecal use.

Preparatory dehydration (e.g. prolonged fasting and the administration of a laxative before Ultravist Injection) is contraindicated in pediatric patients because of risk of renal failure.

SELECTED WARNINGS AND PRECAUTIONS

  • Life-threatening or fatal anaphylactoid reactions may occur during or after Ultravist administration, particularly in patients with allergic disorders.
  • Acute kidney injury, including renal failure, may occur after intravascular administration of Ultravist. Risk factors include: pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinemia, repetitive and/or large doses of Ultravist. Use the lowest necessary dose of Ultravist in patients with renal impairment. Adequately hydrate patients prior to and following Ultravist administration.
  • Hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of Ultravist.
  • Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure. In angiographic procedures, consider the possibility of dislodging plaques or damaging or perforating the vessel wall. The physicochemical properties of the contrast agent, the dose and the speed of injection can influence the reactions.
  • Extravasation of Ultravist may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.
  • Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of any iodinated contrast agent.
  • Administer iodinated contrast agents with extreme caution in patients with known or suspected pheochromocytoma. Inject the minimal amount of contrast necessary.
  • Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.

MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.

Please see full prescribing information.

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References:

1.Data on file. Bayer HealthCare Pharmaceuticals.

2.GADAVIST [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2013.

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