General MedicationsINTRAVENOUSBlack Box

EOVIST

GADOXETATE DISODIUM

Standard Dose

2 DOSAGE AND ADMINISTRATION Recommended dose is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous injection at 1 mL/sec to 2 mL/sec. ( 2.1 ) See Full Prescribing Information for administration and imaging instructions. ( 2.2 , 2.3 ) 2.1 Recommended Dose The recommended dose of EOVIST for adult and pediatric patients, including term neonates, is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at a recommended rate of 1 mL/sec to 2 mL/sec. 2.2 Administration and Drug Handling EOVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ]. Use aseptic technique when preparing and administering EOVIST. Visually inspect EOVIST for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or if particulate matter is present. Use EOVIST immediately after obtaining appropriate dose from vial. Pierce the rubber stopper only once. Discard any unused portion of an EOVIST vial. Do not mix EOVIST with other medications and do not administer EOVIST in the same intravenous line simultaneously with other medications. Flush the intravenous cannula with 0.9% Sodium Chloride Injection after EOVIST injection. 2.3 Imaging Liver lesions are detected and characterized with pre-contrast MRI and EOVIST MRI obtained during dynamic and hepatocyte imaging phases. Perform a pre-contrast MRI, inject EOVIST, and begin dynamic imaging approximately 15 seconds to 25 seconds after completion of the injection. Dynamic imaging consists of the arterial, the porto-venous (approximately 60 seconds post-injection), and the blood equilibrium (approximately 120 seconds) phases. Begin the hepatocyte imaging phase approximately 20 minutes post-injection. Hepatocyte phase imaging may be performed up to 120 minutes post-injection. Elevated intrinsic levels of bilirubin (>3 mg/dL) or ferritin can reduce the hepatic contrast effect of EOVIST. Perform MR imaging no later than 60 minutes following EOVIST administration to patients with these laboratory abnormalities, including patients who have elevated ferritin levels due to hemodialysis [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6 , 8.7) ]. Lesions with no or minimal hepatocyte function (cysts, metastases, and the majority of hepatocellular carcinomas) generally will not accumulate EOVIST. Well-differentiated hepatocellular carcinoma may contain functioning hepatocytes and can show some enhancement in the hepatocyte imaging phase. Additional clinical information is therefore needed to support a diagnosis of hepatocellular carcinoma.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease.

Summary

EOVIST is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended dose is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous injection at 1 mL/sec to 2 mL/sec. ( 2.1 ) See Full Prescribing Information for administration and imaging instructions. ( 2.2 , 2.3 ) 2.1 Recommended Dose The recommended dose of EOVIST for adult and pediatric patients, including term neonates, is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at a recommended rate of 1 mL/sec to 2 mL/sec. 2.2 Administration and Drug Handling EOVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ].

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. EOVIST is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended dose is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous injection at 1 mL/sec to 2 mL/sec. ( 2.1 ) See Full Prescribing Information for administration and imaging instructions. ( 2.2 , 2.3 ) 2.1 Recommended Dose The recommended dose of EOVIST for adult and pediatric patients, including term neonates, is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at a recommended rate of 1 mL/sec to 2 mL/sec. 2.2 Administration and Drug Handling EOVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ]. Use aseptic technique when preparing and administering EOVIST. Visually inspect EOVIST for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or if particulate matter is present. Use EOVIST immediately after obtaining appropriate dose from vial. Pierce the rubber stopper only once. Discard any unused portion of an EOVIST vial. Do not mix EOVIST with other medications and do not administer EOVIST in the same intravenous line simultaneously with other medications. Flush the intravenous cannula with 0.9% Sodium Chloride Injection after EOVIST injection. 2.3 Imaging Liver lesions are detected and characterized with pre-contrast MRI and EOVIST MRI obtained during dynamic and hepatocyte imaging phases. Perform a pre-contrast MRI, inject EOVIST, and begin dynamic imaging approximately 15 seconds to 25 seconds after completion of the injection. Dynamic imaging consists of the arterial, the porto-venous (approximately 60 seconds post-injection), and the blood equilibrium (approximately 120 seconds) phases. Begin the hepatocyte imaging phase approximately 20 minutes post-injection. Hepatocyte phase imaging may be performed up to 120 minutes post-injection. Elevated intrinsic levels of bilirubin (>3 mg/dL) or ferritin can reduce the hepatic contrast effect of EOVIST. Perform MR imaging no later than 60 minutes following EOVIST administration to patients with these laboratory abnormalities, including patients who have elevated ferritin levels due to hemodialysis [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6 , 8.7) ]. Lesions with no or minimal hepatocyte function (cysts, metastases, and the majority of hepatocellular carcinomas) generally will not accumulate EOVIST. Well-differentiated hepatocellular carcinoma may contain functioning hepatocytes and can show some enhancement in the hepatocyte imaging phase. Additional clinical information is therefore needed to support a diagnosis of hepatocellular carcinoma. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur. Monitor patients closely for need of emergency cardiorespiratory support ( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of EOVIST have not been established with intrathecal use. EOVIST is not approved for intrathecal use [see Dosage and Administration (2.2) ]. 5.2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administrated to a patient. For patients at highest risk for NSF, do not exceed the recommended EOVIST dose and allow a sufficient period of time for elimination of the drug prior to any re-administration. For patients receiving hemodialysis, consider the prompt initiation of hemo

Boxed Warning

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. EOVIST is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST 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 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 EOVIST 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 (5.2) ]. WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning. Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. EOVIST is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. ( 5.2 )

Monitoring

• 5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur.
• Monitor patients closely for need of emergency cardiorespiratory support ( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs.
• ( 5.4 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures.
• The safety and effectiveness of EOVIST have not been established with intrathecal use.

Interaction Notes

• 7 DRUG INTERACTIONS Serum Iron Test EOVIST contains caloxetate trisodium that can interfere with serum iron determination using complexometric methods (for example, ferrocene complexation method) and may result in falsely high or low values for up to 24 hours after the administration of EOVIST.
• Conduct serum iron tests either before or at least 24 hours following administration of EOVIST.
• Serum iron determination using complexometric methods (for example, ferrocene complexation method) may result in falsely high or low values for up to 24 hours.
• Conduct serum iron tests either before or at least 24 hours following administration.