Gadovist^® Safety Information

Indication and clinical use:

• GADOVIST 1.0 (gadobutrol) is indicated in adults and children of all ages including term newborns for:
  • Contrast enhancement during cranial and spinal MRI investigations and for contrast-enhanced magnetic resonance angiography (CE-MRA).
  • Contrast enhanced MRI of the breast to assess the presence and extent of malignant breast disease, and MRI of the kidney.
  • GADOVIST 1.0 is particularly suited for cases where the exclusion or demonstration of additional pathology may influence the choice of therapy or patient management, for detection of very small lesions and for visualization of tumors that do not readily take up contrast media.
  • GADOVIST 1.0 is also suited for perfusion studies for the diagnosis of stroke, detection of focal cerebral ischemia and tumor perfusion.

Most serious warnings and precautions:

• Nephrogenic systemic fibrosis (NSF): GBCAs increase the risk for NSF in patients with chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m²) or acute renal failure / acute kidney injury. In these patients, avoid use of GBCAs unless the diagnostic information is essential and not available with noncontrast-enhanced 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 GBCA, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any re- administration.
• Not for intrathecal use: GADOVIST 1.0 is not approved for intrathecal use. Intrathecal administration of GBCAs can cause serious, life-threatening, and fatal reactions, primarily with neurological reactions (e.g. coma, encephalopathy, seizures).

Other relevant warnings and precautions:

• GADOVIST 1.0 is intended for intravenous administration only and may cause tissue irritation and pain if administered extravascularly.
• Gadolinium may accumulate in the brain after multiple administrations of GBCAs. Use the lowest effective dose and perform a benefit risk assessment before administering repeated doses.
• As with other contrast media, GADOVIST 1.0 can be associated with anaphylactoid/hypersensitivity or other idiosyncratic reactions, characterized by cardiovascular, respiratory or cutaneous manifestations, and ranging to severe reactions including shock.
• While there is no evidence suggesting that gadobutrol directly precipitates convulsion, the possibility that it may decrease the convulsive threshold in susceptible patients cannot be ruled out. Precautionary measures should be taken with patients predisposed to seizure, eg, close monitoring and availability of injectable anticonvulsants.
• Use only during pregnancy if the benefits outweigh the risks. Use of macrocyclic agents, such as GADOVIST 1.0, may be preferable in potentially vulnerable patients, including pregnant women.

For more information:

Consult the product monograph for important information about adverse reactions, drug interactions, and dosing instructions. The Product Monograph is also available by calling Bayer Medical Information at 1-800-265-7382.