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*
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.