Drug Detail:Omniscan prefill plus (Gadodiamide [ gad-oh-dye-a-mide ])
Drug Class: Magnetic resonance imaging contrast media
Usual Adult Dose for CNS Magnetic Resonance Imaging
To visualize lesions with abnormal vascularity in the brain, spine, and associated tissues:
0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.
Usual Adult Dose for Vascular Magnetic Resonance Imaging
To facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space:
Kidney: 0.1 mL/kg (0.05 mmol/kg) administered as a bolus intravenous injection.
Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.
Usual Pediatric Dose for CNS Magnetic Resonance Imaging
To visualize lesions with abnormal vascularity in the brain, spine, and associated tissues:
2 years and older:
0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.
Usual Pediatric Dose for Vascular Magnetic Resonance Imaging
To facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space:
2 years and older:
Kidney: 0.1 mL/kg (0.05 mmol/kg) administered as a bolus intravenous injection.
Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.
Renal Dose Adjustments
Gadodiamide is contraindicated in patients with acute kidney injury or chronic, severe kidney disease. All patients should be screened for renal dysfunction by obtaining a history and/or laboratory tests.
Liver Dose Adjustments
Data not available
Precautions
US BOXED WARNINGS:
- NOT FOR INTRATHECAL USE: Inadvertent intrathecal use of this drug has caused convulsions, coma, sensory and motor neurologic deficits.
- 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 such patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not administer to patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m2) or acute kidney injury. Patients should be screened for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., greater than 60 years of age, hypertension, or diabetes), estimate the GFR through laboratory testing. Do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration.
Safety and efficacy have not been established in patients younger than 2 years; safety and efficacy of greater than 0.1 mmol/kg and of repeated doses have not been studied in pediatric patients.
Consult WARNINGS section for additional precautions.
Dialysis
Gadodiamide is contraindicated in patients with acute kidney injury or chronic, severe kidney disease.