Magnevist® (gadopentetate dimeglumine) injection 0.5 mmol/mL

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Magnevist® (gadopentetate dimeglumine) injection

Overview

Magnevist® Overview

Indication

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.

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.

Safety profile in pivotal clinical trials1

Adverse Reaction Trial Chart

Occurring in ≥1% of patients.

  • In US 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

Please see Full Prescribing Information, including boxed warning.

References: 1. Magnevist Injection [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2014.

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Packaging

Packaging

Magnevist® (gadopentetate dimeglumine) injection is an MRI-contrast agent with a 24-hour time of use for both 50-mL and 100-mL multi-dose Pharmacy Bulk Packages.

A full range of versatile presentations:

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Reimbursement

Reimbursement

The Bayer Imaging Reimbursement Helpline is available to all institutions to provide further information. The Helpline can be reached by phone (1-800-423-7539).

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Purchasing

Purchasing Resources

In today's cost-conscious healthcare environment, Bayer HealthCare LLC offers a comprehensive line of quality imaging products at competitive prices combined with highly regarded service and support. Knowing that purchasers have unique requirements, we do our best to provide creative yet competitive contracts that go beyond just meeting product needs. Additional purchasing resources are described below.

Bayer HealthCare LLC's partnership with McKesson Specialty Care Solutions combines Bayer's commitment to our customers with the drug distribution of McKesson, focused on delivering the right product to the right place at the right time. McKesson's reputation for reliable service makes them an ideal solution through which to source your Bayer HealthCare LLC imaging products.

Suppliers are listed below in alphabetical order.

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INDICATIONS and IMPORTANT SAFETY INFORMATION

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.

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.

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You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.