MULTIHANCE- gadobenate dimeglumine injection, solution
BRACCO DIAGNOSTICS INC
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
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 systemic 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 (e.g. 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 MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration. [see Warnings and Precautions (5.1) ]
1 INDICATIONS AND USAGE
1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)
MultiHance is indicated for intravenous use in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues.
1.2 Magnetic Resonance Angiography (MRA) of Renal and Aorto-ilio-femoral Vessels
MultiHance is indicated for use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing and Imaging Instructions
2.1.1 MRI of the CNS
In adults and in pediatric patients over 2 years of age, the recommended dose of MultiHance for MRI of the CNS is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection. In pediatric patients below 2 years of age, the recommended dosage range is 0.1 to 0.2 mL/kg administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance.
2.1.2 MRA of Renal and Aorto-ilio-femoral Vessels
For MRA examination, the recommended dose is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.
2.2 Dosing Table
|*For pediatric patients less than 2 years of age, one-half of the per kg dose may be used.|
|TABLE 1: WEIGHT-BASED DOSING VOLUMES FOR:CNS IMAGING (ADULTS AND PEDIATRICS ≥2 YEARS OF AGE*)ANDMRA IMAGING (ADULTS ONLY)|
|Kilograms (Kg)||Pounds (lb)||Volume, Milliliters (mL)|
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