(gadobutrol) injection, for intravenous use
WARNING: 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/1.73m2), 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 (for example, 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 Gadavist (gadobutrol) dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see WARNINGS AND PRECAUTIONS].
Gadavist (gadobutrol) Injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging. The chemical name for gadobutrol is 10-[(lSR,2RS)-2,3-dihydroxy-l-hydroxymethylpropyl]-l,4,7,10-tetraazacyclododecane-l,4,7-triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of C18H31GdN4O9 and a molecular weight of 604.72.
Gadavist (gadobutrol) is a clear, colorless to pale yellow solution containing 1 mmol gadobutrol (equivalent to 604.72 mg gadobutrol) per mL as the active ingredient and the excipients calcobutrol sodium, trometamol, hydrochloric acid (for pH adjustment) and water for injection. Gadavist (gadobutrol) contains no preservatives.
The main physico-chemical properties of Gadavist (gadobutrol) (1 mmol/mL solution for injection) are listed below:
|Osmolarity at 37°C (mOsm/L solution)||1117|
|Osmolality at 37°C (mOsm/kg H2O)||1603|
|Viscosity at 37°C (mPa·s)||4.96|
Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Gadavist Information
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