BlackBoxRX
 
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Gadolinium Based Contrast Agents: Gadobenate, Gadobutrol, Gadodiamide, Gadofosveset, Gadopentetate, Gadoterate meglumine, Gadoteridol, Gadoversetamide, Gadoxetate Disodium

Nephrogenic Systemic Fibrosis

  • GBCAs increase the risk of Nephrogenic Systemic Fibrosis (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-contrast enhanced magnetic resonance imaging (MRI) or other modalities.
  • NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs.
  • The risk for NSF appears highest in patients with: acute or chronic severe renal insufficiency (GFR < 30mL>
  • Do not administer to patients with chronic kidney disease (glomerular filtration rate
  • Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 yrs, hypertension or diabetes), estimate glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk of NSF, do not exceed the dose recommended in product labeling. Allow sufficient time for elimination of the GBCA prior to any any readministration.

Gadodiamide Only

  • NOT FOR INTRATHECAL USE:Inadvertent intrathecal use of Omniscan has caused convulsions, coma, sensory and motor neurologic deficits [see WARNINGS and PRECAUTIONS (5.4)].

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Screen patients for acute kidney injury and other conditions that may reduce renal function
  • Estimate the glomerular filtration rate through laboratory testing for patients at risk for chronically reduced renal function
  • Record the specific GBCA and dose administered
  • Not exceed the recommended GBCA dose
  • Allow a sufficient time for elimination of the drug from the body prior to any re-administration

PATIENT CARE PLAN

FDA and Industry Communications

Medication Guides

Patient Medication Guides

Package Inserts

Gadobenate

Gadodiamide

Gadopentetate

Gadoteridol

Gadoversetamide

Gadoxetate Disodium

Updated January 2018