Eovist (Gadoxetate Disodium Injection) Drug Overview and Uses for Patients and Caregivers at RxList

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May 27, 2012

Eovist

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What is liver disease?

Liver disease is any disturbance of liver function that causes illness. The liver is responsible for many critical functions within the body and should it become diseased or injured, the loss of those functions can cause significant damage to the body. Liver disease is also referred to as hepatic disease.

Liver disease is a broad term that covers all the potential problems that may occur to cause the liver to fail to perform its designated functions. Usually, more than 75% or three quarters of liver tissue needs to be affected before decrease in function occurs.

The liver the largest solid organ in the body; and is also considered a gland because among its many functions, it makes and secretes bile. The liver is located in the upper right portion of the abdomen protected by the rib cage. It has two main lobes that are made up of tiny lobules. The liver cells have two different sources of blood supply. The hepatic ...

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Eovist

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EOVIST
(gadoxetate disodium)

WARNING

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 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 < 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 (for example, 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 EOVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

EOVIST (gadoxetate disodium) is a paramagnetic contrast agent for MRI. EOVIST is provided as a sterile, clear, colorless to pale yellow aqueous solution for intravenous injection.

EOVIST contains the active pharmaceutical ingredient gadoxetate disodium (Gd-EOB-DTPA), which is designated chemically as (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxylatomethyl)-3,6,9triazaundecanedioic acid, gadolinium complex, disodium salt with a molecular weight of 725.72 and an empirical formula of GdC₂₃H₂₈N₃O₁₁Na₂. The structural formula of gadoxetate disodium in aqueous solution is:

EOVIST (Gadoxetate Disodium) Structural Formula Illustration

Each mL of EOVIST contains 181.43 mg of gadoxetate disodium (equivalent to 0.25 mol/L gadoxetate disodium) and the excipients caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection. EOVIST contains no antimicrobial preservative.

EOVIST has a pH of 6.8 to 8. Pertinent physiochemical data are provided below:

TABLE 2 : Physicochemical Properties