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MRI Safety

Role of MRI in Multiple Sclerosis (MS)

MRI is one of the cornerstones of multiple sclerosis (MS) management, fulfilling diverse roles such as:

Initial diagnosis in conjunction with clinical evidence;also diagnosis of flares. Especially in the presence of clinical findings suggestive of MS, positive MRI studies provide confirmatory and prognostic evidence.

Following disease progression—Enhanced MRI detects new disease activity seven times more frequently than does merely monitoring clinical events and twice as often as unenhanced MRI in patients with relapsing-remitting or secondary-progressive MS.

Assessing the efficacy of the current therapeutic options, MRI documents disease activity and lesion loads in patients.

MRI techniques are an important tool used to confirm the presence of the disease and also to exclude other conditions that may mimic MS, for example, systemic lupus erythematosus, migraines, Lyme disease, acute disseminated encephalomyelitis, metastases or brain abscesses. The sensitivity of MRI in the context of MS is such that many clinicians will refrain from making an initial diagnosis of MS if the MRI is normal even if clinical findings suggest the disease.

Several MRI techniques are employed in the management of MS in addition to classic protocols including diffusion imaging, T2 relaxation analysis, proton spectroscopy, FLAIR sequences and magnetization transfer. Some of these techniques utilize contrast agents such as MAGNEVIST® (gadopentetate dimeglumine) injection, while others involve unenhanced imaging.

At present, MS is thought to be a progressive disease but it is difficult to predict which patients will experience rapid debilitation versus those whose clinical course is more favorable. MRI activity may correlate with long-term disability and MRI studies suggest that patients with high initial lesion loads tend to have more rapidly progressive disease clinically and pathologically than do those presenting with lower lesion loads. MRI can be used to help monitor long-term response to MS therapies.

It is important for clinicians to determine which patients are more likely to have progressive conditions since early aggressive treatment may help prevent the development of severe neurologic disabilities.

The exact relationship between MRI findings and the clinical status of patients is not completely understood.

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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.

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.

Role of MRI in Multiple Sclerosis (MS)

INDICATIONS and IMPORTANT SAFETY INFORMATION

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