Indications and Usage:
MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL is indicated for intravenous use in MRI of the central nervous system in adults and children over 2 years of age to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues. It is also approved for MRA to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
IMPORTANT SAFETY INFORMATION:
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
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 systemic fibrosis affecting the skin, muscle and internal organs.
- The risk for NSF appears highest among 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 (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
- For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration. [see Warnings and Precautions (5.1)]
Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations ranging from mild to severe. The possibility of a reaction should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders.
Please see full Prescribing Information for MultiHance (gadobenate dimeglumine) injection, 529 mg/mL including boxed WARNING by clicking here.
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.
MultiHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany) and by Patheon Italia S.p.A., Ferentino, Italy.
MultiHance is a registered trademark of Bracco International B.V.
MultiHance Multipack is a trademark of Bracco International B.V.
All trademarks and registered trademarks are the property of their respective owners.