Gadolinium Based Contrast Agents: Gadobenate, Gadobutrol, Gadodiamide, Gadofosveset, Gadopentetate, Gadoterate meglumine, Gadoteridol, Gadoversetamide, Gadoxetate Disodium, Gadopiclenol
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.
- 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
- Information for Healthcare Professionals Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging(marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance)
- Class Labeling Change: Risk of Nephrogenic Systemic Fibrosis (Sep 2010)
- FDA Drug Safety Podcasts on Class Labeling Change [Sep 2010]
- Information Index to FDA Safety Information
gadoversetamide (Optimark) was discontinued in 2018