Usual Adult Dose for CNS Magnetic Resonance Imaging

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use: Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Usual Adult Dose for Diagnostic

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use: Indicated for use with MRI to assess the presence and extent of malignant breast disease.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use:

• Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING(S):
NEPHROGENIC SYSTEMIC FIBROSIS (NSF):

• Gadolinium-based contrast agents (GBCAs) increase the risk of NSF in patients with impaired drug elimination; avoid use in these patients unless diagnostic information is essential and not available with non-contrasted magnetic resonance imaging (MRI) or other modalities.
• NSF may cause fatal or debilitation fibrosis affecting the skin, muscle, and internal organs.
• NSF risk appears to be highest in chronic, severe kidney disease (GFR under 30 mL/min/1.73m2) or with acute kidney injury.
• Screen for acute kidney injury or other causes of reduced renal function.
• Patients at risk for chronically reduced renal function (e.g. over 60 years old, hypertension, diabetes) should have glomerular filtration rate (GFR) estimated through laboratory testing.
• For patients at the highest risk of NSF, do not exceed the recommended dose and allow sufficient time for drug elimination prior to any re-administration.

• Severe hypersensitivity to this product

Dialysis

Hemodialysis: May consider the prompt initiation of hemodialysis following the administration of the drug in order to enhance elimination.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Administer as IV bolus injection (manually or power injector) at a flow rate of approximately 2 mL/second.
• Follow injection with saline flush to ensure complete administration of the drug.
• Contrast enhanced MRI can begin immediately following drug administration.

• Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F).
• If freezing of drug occurs, bring to room temperature before use.
• If allowed to stand at room temperature, the drug should return to a clear and colorless to pale yellow solution.

• Screen patients for acute kidney injury (AKI) and other conditions that may reduce renal function. Estimate GFR for patients who are at risk for chronically reduced renal function (age greater than 60, diabetes, or hypertension).
• Monitor patients closely during and after administration of the drug for signs and symptoms of hypersensitivity reactions.

• Instruct the patients to contact their physician if they develop signs or symptoms of NSF following administration of the drug, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.