Important Safety Information
Full Prescribing Information
Medication Guide
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  • Magnevist® 

FDA-approved in 1988, Magnevist® represents Bayer’s dedication to development of contrast agents.

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 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.

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 Magnevis®.

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 trials

Adverse Reactions in U.S. Clinical Trials*

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*Occurring in ≥1% of patients.

In U.S. clinical trials of 1,272 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.

 

The recommended dosage of Magnevist® injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.  

To ensure complete injection of gadopentetate dimeglumine, administer 5-mL normal saline flush after the injection. The imaging procedure should be completed within 1 hour of the Magnevist® injection.  

Visually inspect 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. Discard any unused portion in accordance with regulations dealing with the disposal of such materials.

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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:

Packaging

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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, which can provide potential contrast waste reduction.