"An experimental drug aimed at treating a common liver disease showed promising results and potential problems in a multicenter clinical trial funded by the National Institutes of Health. The FLINT study found that people with nonalcoholic stea"...
DOSAGE AND ADMINISTRATION
EOVIST is for intravenous administration. The recommended dose of EOVIST is 0.1 mL/kg body weight (0.025 mmol/kg body weight).
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. EOVIST should not be mixed with other drugs. EOVIST is intended for single use, and should be used immediately after opening. The rubber stopper should never be pierced more than once.
Administer EOVIST undiluted as an intravenous bolus injection at a flow rate of approximately 2 mL/second. Flush the intravenous cannula with physiological saline solution after the injection. Discard any unused portion of an EOVIST vial.
Liver lesions are detected and characterized with pre-contrast MR images and EOVIST MR images obtained during dynamic and hepatocyte imaging phases. During the dynamic imaging phases, use the temporal enhancement and washout pattern of intravascular EOVIST to assess lesions. Further assess lesions during a hepatocyte imaging phase, based upon the pattern of EOVIST accumulation within hepatocytes. Perform a pre-contrast MRI, inject EOVIST and begin dynamic imaging approximately 15–25 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 and Use In Specific Populations].
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.
Dosage Forms And Strengths
EOVIST is a clear, colorless to pale yellow, ready-to-use aqueous solution. Each mL of EOVIST contains 181.43 mg gadoxetate disodium (equivalent to 0.25 mol/L) and is available in single use vials.
Storage And Handling
Dosage Forms Supplied
EOVIST is supplied in single-dose, rubber stoppered vials containing 181.43 mg/mL of gadoxetate disodium, equivalent to 0.25 mmol/mL, in the following sizes:
10 mL single-dose vials filled with 10 mL, boxes of 5 NDC 50419-320-05
10 mL single-dose vials (RFID) filled with 10 mL, boxes of 5 NDC 50419-320-43
Storage and Handling
EOVIST is a ready-to-use solution for single use only. The rubber stopper should never be pierced more than once. Unused portions should be discarded.
EOVIST should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or if particulate matter is present.
EOVIST should be used immediately after opening. EOVIST should not be mixed with other drugs. EOVIST should be stored at temperatures between 20–25°C (68–77°F); excursions permitted to 15–30° C [see USP Controlled Room Temperature].
Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Manufactured in Germany. November 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/7/2011
Additional Eovist Information
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