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 Injection 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 Injection is indicated for use in 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
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.
The possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory, and/or cutaneous manifestations, should always be considered. As with other paramagnetic contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function. As with other injectable products, cases of phlebitis and thrombophlebitis have been reported; assessment of the dosed limb for the development of injection site reactions is recommended.
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.
For important risk and use information, please see the 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
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.
The possibility of serious or life-threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. The most common adverse reactions observed in clinical trials at the recommended dose included feeling hot, nausea and headache.
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.
For important risk and use information, please see the full prescribing information.
ULTRAVIST® (iopromide) Injection
INDICATIONS AND USAGE
INTRA-ARTERIAL: ULTRAVIST® (iopromide) Injection (150 mgI/mL) is indicated for intra-arterial digital subtraction angiography (IA-DSA). ULTRAVIST Injection (300 mgI/mL) is indicated for cerebral arteriography and peripheral arteriography. ULTRAVIST Injection (370 mgI/mL)* is indicated for coronary arteriography and left ventriculography, visceral angiography, and aortography.
INTRAVENOUS: ULTRAVIST Injection (240 mgI/mL) is indicated for peripheral venography. ULTRAVIST Injection (300 mgI/mL)* is indicated for contrast enhanced computed tomographic (CECT) imaging of the head and body, and excretory urography.
*For information on the concentrations and doses for the Pediatric Population see the full prescribing information.
IMPORTANT SAFETY INFORMATION
All nonionic, iodinated contrast media currently available inhibit blood coagulation in vitro less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary to minimize thromboembolic events. As with all iodinated contrast agents, serious or fatal reactions have been associated with their use. Ultravist Injection is not indicated for intrathecal use.
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.
For important risk and use information, please see the full prescribing information.
FERIDEX I.V.® (ferumoxides injectable solution)
INDICATION AND USAGE
Feridex I.V. is indicated for I.V. administration as an adjunct to MRI (in adult patients) to enhance the T2 weighted images used in the detection and evaluation of lesions of the liver that are associated with an alteration in the RES.
IMPORTANT SAFETY INFORMATION
Anaphylactic-like reactions and hypotension have been noted in some patients receiving FERIDEX I.V., other iron and dextran containing formulations, or radiographic contrast media. In clinical trials, anaphylactic and allergic adverse events occurred in 11/2240 (0.5%) of the patients who received FERIDEX I.V. These events included dyspnea, other respiratory symptoms, angioedema, generalized urticaria, and hypotension; and required treatment.
There is not sufficient evidence to support differentiation of lesions as benign or malignant with FERIDEX I.V. Based on clinical studies, the mean number of lesions seen before and after FERIDEX I.V. were comparable.
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.
For important risk and use information, please see the full prescribing information.
