MAGNEVIST Injection Prescribing Information (Vials and Syringes)
MAGNEVIST Injection Prescribing Information (Pharmacy Bulk Package)
MAGNEVIST® (gadopentetate dimeglumine) Injection
Indications
Clinical experience
Safety profile in pivotal clinical trials
Indications
*Excluding the heart.
† 2-18 years of age.
NSF boxed warning
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 (see CONTRAINDICATIONS)
- 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 any re-administration (see WARNINGS AND PRECAUTIONS).
Please see full prescribing information.
Clinical experience
Leading the market with 100+ million procedures – and counting.‡ §
Anaphylactoid/hypersensitivity reactions
The possibility of serious or life-threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. Acute reactions including cardiac or respiratory arrest, anaphylactoid shock and shock have been reported.
Please see full prescribing information, including boxed warning.
Safety profile in pivotal clinical trials2
#Occurring in ≥1% of patients.
- In United States clinical trials of 1272 patients, the most frequently reported adverse reactions included headache, nausea, and injection site coldness/localized coldness
- Clinical trials have demonstrated efficacy and safety of MAGNEVIST at the approved dose of 0.1 mmol/kg across all indications
- Serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory, and/or cutaneous manifestations, should always be considered
1995 Post-marketing safety study3
In a 15,496-patient study adverse reactions were reported in 372 patients (2.4%).
Additional post-marketing safety information:
- Cases of phlebitis and thrombophlebitis have been reported; assessment of the dosed limb for the development of injection site reactions is recommended
- The most serious reactions were nephrogenic systemic fibrosis (see Boxed Warning) and acute reactions including cardiac or respiratory arrest, anaphylactic shock, respiratory distress, and laryngeal edema
- Gadolinium-based contrast agents, including MAGNEVIST, increase the risk of nephrogenic systemic fibrosis (NSF). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Do not administer MAGNEVIST to patients with chronic or severe kidney disease (glomerular filtration rate, GFR <30 mL/min 1.732) or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function.
Please see full prescribing information, including boxed warning.
INDICATIONS and IMPORTANT SAFETY INFORMATION
MAGNEVIST (gadopentetate dimeglumine) Injection
INDICATIONS AND USAGE
Central Nervous System: Magnevist® (gadopentetate dimeglumine) Injection is indicated for 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 facilitate the visualization of 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 facilitate the visualization of 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 (see CONTRAINDICATIONS)
- 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 any re-administration (see WARNINGS AND PRECAUTIONS).
- Magnevist is contraindicated in patients with chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2), or acute kidney injury.
- The possibility of serious or life-threatening hypersensitivity, anaphylactic or anaphylactoid reactions associated with cardiovascular, respiratory, or cutaneous manifestations, including death, should always be considered.
- Caution should be exercised in patients with renal impairment due to the possibility of further deterioration in renal function.
- Cases of phlebitis and thrombophlebitis have been reported; assessment of the dosed limb for the development of injection site reactions is recommended.
- In clinical trials, the most frequently reported adverse reactions included headache, nausea, injection site coldness/localized coldness and dizziness.
Please see full prescribing 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 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 Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions].
- The possibility of serious or life-threatening hypersensitivity, anaphylactic or anaphylactoid reactions associated with cardiovascular, respiratory, or cutaneous manifestations, including death, should always be considered.
- The most frequent adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot.
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 re-administration (see WARNINGS AND PRECAUTIONS).
- The possibility of life-threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered.
- The most frequent (≥0.5%) adverse reactions associated with the use of Eovist are nausea, headache, feeling hot, dizziness, and back pain.
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.
References:
‡ Bayer HealthCare Pharmaceuticals employed numerous sources, including Arlington Medical Resources Inc., to estimate MRI contrast procedure numbers. [Data on file. Bayer HealthCare Pharmaceuticals.]
§ Estimated from first market launch through January 2009. [Data on file. Bayer HealthCare Pharmaceuticals.]
|| Results based on a comprehensive search of the literature in the following databases through January 2009: BIOSIS, Current Contents, Derwent Drug File, EMBASE, Drug Research and Pharmacology, and MEDLINE. [Data on file. Bayer HealthCare Pharmaceuticals.]
¶ Year-end DDD Data 2009. [Data on file. Bayer HealthCare Pharmaceuticals.]
1.Runge VM, Schaible TF, Goldstein HA, et al. Gd DTPA. Clinical efficacy. Radiographics. 1988;8(1):147-159.
2.Magnevist Injection [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2009.
3.Nelson KL, Gifford LM, Lauber-Huber C, Gross CA, Lasser TA. Clinical safety of gadopentetate dimeglumine. Radiology. 1995;196:439-443.
