Gadoterate Meglumine - Gadoterate Meglumine injection Prescribing Information
- The risk for NSF appears highest among patients with:
- Chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m2), 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 more than 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing .
- For patients at highest risk for NSF, do not exceed the recommended Gadoterate Meglumine Injection 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 ]
Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Gadoterate Meglumine Injection, USP 0.5 mmol per mL is a sterile, clear, colorless to yellow, aqueous solution for intravenous injection containing 376.9 mg per mL gadoterate meglumine. Gadoterate Meglumine Injection, USP (5 mL, 10 mL, 15 mL and 20 mL) is available in single dose vials. Gadoterate Meglumine Injection, USP Pharmacy Bulk Package is available in vials.
History of clinically important hypersensitivity reactions to Gadoterate Meglumine Injection
GBCAs have been associated with a risk for NSF
Hypersensitivity reactions and acute kidney injury are described in other sections of the labeling
Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with gadoterate meglumine have not been conducted.