Gadoxetate Disodium

Gadoxetate Disodium Brand Name– Eovist

What is Gadoxetate Disodium

Gadoxetate is a paramagnetic contrast agent used during magnetic resonance imaging (MRI) of the liver to detect or assess lesions in patients with known or suspected focal hepatic disease.

Approval was based on the results of 4 trials (2 lesion detection trials, 2 lesion morphologic characterization trials). In each trial, patients underwent a baseline pre-contrast MRI followed by a gadoxetate enhanced MRI; images were evaluated by 3 blinded radiologists.

For all 3 readers, use of gadoxetate in combination with the pre-contrast images resulted in improved sensitivity for detection and characterizations of hepatic lesions, when compared to pre-contrast images alone.

Gadoxetate, like all gadolinium-based contrast agents (GBCAs), carries a black box warning for nephrogenic systemic fibrosis (NSF). NSF is a serious condition that may result in fatal or debilitating fibrosis of the skin, muscle, and internal organs.

The propensity to cause NSF differs among available GBCAs; most unconfounded cases have been reported with gadodiamide, gadopentetate dimeglumine, and gadoversetamide.

According to the American College of Radiology, an association of gadoxetate with NSF has not been determined.

Gadoxetate was FDA-approved in July 2008.

Indications

  • magnetic resonance imaging (MRI)

For use with magnetic resonance imaging (MRI) to detect and characterize liver lesions in patients with known or suspected focal hepatic disease

Side Effects

  1. abdominal pain
  2. akathisia
  3. anaphylactic shock
  4. anaphylactoid reactions
  5. back pain
  6. bundle-branch block
  7. chest pain (unspecified)
  8. chills
  9. conjunctivitis
  10. cough
  11. dizziness
  12. dysgeusia
  13. dyspnea
  14. fatigue
  15. flushing
  16. headache
  17. hyperbilirubinemia
  18. hyperhidrosis
  19. hypersalivation
  20. hypertension
  21. hypoesthesia
  22. hypotension
  23. injection site reaction
  24. laryngeal edema
  25. maculopapular rash
  26. malaise
  27. nausea
  28. nephrogenic systemic fibrosis (nephrogenic fibrosing dermopathy)
  29. pallor
  30. palpitations
  31. paresthesias
  32. parosmia
  33. pruritus
  34. rash
  35. renal failure (unspecified)
  36. restlessness
  37. rhinitis
  38. sinus tachycardia
  39. skin irritation
  40. sneezing
  41. tremor
  42. urticaria
  43. vertigo
  44. vomiting
  45. xerostomia

Monitoring Parameters

  • serum creatinine/BUN

Contraindications

  • asthma
  • atopy
  • breast-feeding
  • diabetes mellitus
  • dialysis
  • extravasation
  • geriatric
  • hypertension
  • magnetic resonance imaging (MRI)
  • nephrogenic systemic fibrosis (nephrogenic fibrosing dermopathy)
  • pregnancy
  • radiopaque contrast media hypersensitivity
  • renal disease
  • renal failure
  • renal impairment
  • sickle cell disease

Interactions

There are no drug interactions associated with Gadoxetate Disodium products.

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