WAYNE, N.J., March 14, 2011 /PRNewswire/ — Bayer HealthCare
Pharmaceuticals Inc. announced today that the U.S. Food and Drug
Administration has approved Gadavist™ (gadobutrol) Injection,
a macrocyclic gadolinium-based contrast agent (GBCA), for
intravenous use in diagnostic magnetic resonance imaging (MRI) in
adults and children (2 years of age and older) to detect and
visualize areas with disrupted blood brain barrier (BBB) and/or
abnormal vascularity of the central nervous system (CNS).
Gadavist is formulated at a higher concentration (1 mmol/mL)
compared to certain other GBCAs. Compared to 0.5 molar
gadolinium-based contrast agents, the higher concentration of
Gadavist results in half the volume of administration and a more
compact contrast bolus. It is important to closely examine
the dosing table in the full prescribing information to determine
the volume of Gadavist to be administered.
“The approval of Gadavist enriches our strong portfolio of MRI
contrast media and provides a new option for U.S. healthcare
providers in contrast-enhanced imaging of the CNS,” said John
Rotondo, Vice President, Commercial Operations, Bayer HealthCare
Pharmaceuticals. “Our MR contrast agents are some of the most
widely used today, and Bayer is proud to be a world leader in
diagnostic imaging.”IMPORTANT SAFETY INFORMATIONWARNING:
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.
The risk for NSF appears highest among patients with: Chronic,
severe kidney disease (GFR < 30 mL/min/1.73m(squared)), or Acute
kidney i
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