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.

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

• Accountable Action Plan Template - Gaopentate dimeglumine injection

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

Medication Guides

Patient Medication Guides

• DOTAREM   EOVIST   GADAVIST   MAGNEVIST   MULTIHANCE   OMNISCAN PROHANCE  ELUCIREM

Package Inserts

Gadobenate

Gadodiamide

Gadopentetate

Gadoteridol

Gadoxetate Disodium

Additional Information

gadoversetamide (Optimark) was discontinued in 2018