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
- abdominal pain
- akathisia
- anaphylactic shock
- anaphylactoid reactions
- back pain
- bundle-branch block
- chest pain (unspecified)
- chills
- conjunctivitis
- cough
- dizziness
- dysgeusia
- dyspnea
- fatigue
- flushing
- headache
- hyperbilirubinemia
- hyperhidrosis
- hypersalivation
- hypertension
- hypoesthesia
- hypotension
- injection site reaction
- laryngeal edema
- maculopapular rash
- malaise
- nausea
- nephrogenic systemic fibrosis (nephrogenic fibrosing dermopathy)
- pallor
- palpitations
- paresthesias
- parosmia
- pruritus
- rash
- renal failure (unspecified)
- restlessness
- rhinitis
- sinus tachycardia
- skin irritation
- sneezing
- tremor
- urticaria
- vertigo
- vomiting
- 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.
