Eovist

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

Osmolality at 37C (Osm/kg H2O) 0.688
Viscosity at 37C (cP) 1.19
Density at 37C (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 any of these serious side effects:

  • trouble breathing;
  • chest pain;
  • fast or pounding heartbeats; or
  • skin changes where the injection was given.

Less serious side effects...

Read All Potential Side Effects and See Pictures of Eovist


Eovist Patient Information Including Side Effects

Brand Names: Eovist

Generic Name: gadoxetate (Pronunciation: gad OX e tate)

  • What is gadoxetate (Eovist)?
  • What are the possible side effects of gadoxetate (Eovist)?
  • What is the most important information I should know about gadoxetate (Eovist)?
  • What should I discuss with my health care provider before receiving gadoxetate (Eovist)?
  • How is gadoxetate used (Eovist)?
  • What happens if I miss a dose (Eovist)?
  • What happens if I overdose (Eovist)?
  • What should I avoid after receiving gadoxetate (Eovist)?
  • What other drugs will affect gadoxetate (Eovist)?
  • Where can I get more information?

What is gadoxetate (Eovist)?

Gadoxetate is a contrast agent. Gadoxetate produces magnetic effects. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.

Gadoxetate is used to help diagnose certain disorders of the liver.

Gadoxetate may also be used for other not those listed in this medication guide.

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 any of these serious side effects:

  • trouble breathing;
  • chest pain;
  • fast or pounding heartbeats; or
  • skin changes where the injection was given.

Less serious side effects may include:

  • headache, tired feeling;
  • dizziness, spinning sensation;
  • nausea, vomiting;
  • back pain;
  • dry mouth, mouth pain or discomfort;
  • decreased sense of taste or smell;
  • increased sweating or salivation;
  • warmth, redness, or tingly feeling under your skin;
  • mild skin rash or itching;
  • feeling unusually hot; or
  • cold feeling, warmth, pain, or burning where the injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about gadoxetate (Eovist)?

Gadoxetate can cause a life-threatening condition in people with advanced kidney disease who are undergoing an MRI. The symptoms of this condition include:

  • burning, itching, swelling, and tightening or hardening of your skin;
  • muscle weakness;
  • pain or stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • yellow patches on the whites of your eyes; or
  • skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease. You may not be able to receive an MRI with gadoxetate.

Also tell your doctor if you have liver disease, a bleeding or blood-clotting disorder, a history of stroke or blood clots, circulation problems, asthma or allergies, if you have had a liver transplant, or if you are on dialysis.

Some of the side effects of gadoxetate can occur up to several days after you have received the medication.

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