"The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.
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 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–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10– tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of C18H31GdN4O9 and a molecular weight of 604.72.
Gadavist is a sterile, clear, colorless to pale yellow solution containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol/mL) as the active ingredient and the excipients calcobutrol sodium, trometamol, hydrochloric acid (for pH adjustment) and water for injection. Gadavist contains no preservatives.
The main physicochemical properties of Gadavist (1 mmol/mL solution for injection) are listed below:
|Density (g/mL at 37°C)||1.3|
|Osmolarity at 37°C (mOsm/L solution)||1117|
|Osmolality at 37°C (mOsm/kg H2O)||1603|
|Viscosity at 37°C (mPa•s)||4.96|
The thermodynamic stability constants for gadobutrol (log Ktherm and log Kcond at pH 7.4) are 21.8 and 15.3, respectively.
What are the possible side effects of gadobutrol (Gadavist)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects of gadobutrol may occur up to several days after injection.
Call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst, loss of appetite;
- swelling, weight gain, feeling short of breath;
- seizure (convulsions);
- breathing problems;
Last reviewed on RxList: 1/15/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Gadavist Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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