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(gadoxetate disodium) Solution for Intraveinous Injection
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].
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:
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
|Osmolality at 37°C (Osm/kg H2O)||0.688|
|Viscosity at 37°C (cP)||1.19|
|Density at 37°C (g/mL)||1.088|
What are the possible side effects of gadoxetate (Eovist)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some of the side effects of gadoxetate can occur up to several days after you have received the medication.
Call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst, loss of appetite;
- swelling, weight gain, feeling short of breath; or
- swelling, irritation, or skin changes where...
Last reviewed on RxList: 12/6/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Eovist Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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