Can Dotarem cause NSF?

NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following DOTAREM administration to Guerbet LLC (1-877-729-6679) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).

Is Dotarem FDA approved?

Guerbet LLC USA has announced that the U.S. Food and Drug Administration (FDA) has approved Dotarem® (gadoterate meglumine) for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier …

What class is Dotarem?

Dotarem belongs to a class of drugs called Diagnostic Imaging Agents; Gadolinium-Containing Contrast Agents.

Is Dotarem safer than gadolinium?

Over the last three decades, gadolinium contrast injections have successfully been used in hundreds of millions of patients. It’s safe, not radioactive and is different (and better) than the contrast agents used for a CT scan. The U.S. Food and Drug Administration has approved Dotarem as safe for use in MRI scans.

Is Dotarem a Group 2 contrast agent?

Double dosing) of group II/III agent (such as Dotarem or Eovist) per protocol (ex. Some Cardiac MRI exams, Gamma-Knife Met protocol brain MRI) require renal function screening as a larger dose of Gadolinium is being used.

Is Dotarem macrocyclic?

Dotarem® was approved by the U.S. Food and Drug Administration (FDA) in 2013 as the first macrocyclic, ionic GBCA in the United States. In just seven years, it has become the No. 2 MR contrast agent in the U.S. and is currently No. 1 in the world, with more than 100 million doses administered in 70 countries.

Is DOTAREM safe for kidneys?

Dotarem can cause a life-threatening condition in people with advanced kidney disease. You should not receive this medicine if you have kidney disease or if you are on dialysis.

What is the Hcpcs code for DOTAREM?

DOTAREM (gadoterate meglumine), having received FDA approval for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues in adult and pediatric patients (including term neonates), has a distinct Healthcare Common Procedural Coding System (HCPCS) code, A9575 Injection, gadoterate meglumine.

Is DOTAREM a Group 2 contrast agent?

How safe is DOTAREM contrast?

Serious adverse reactions in the Postmarketing experience have been reported with DOTAREM. These serious adverse reactions include but are not limited to: arrhythmia, cardiac arrest, respiratory arrest, pharyngeal edema, laryngospasm, bronchospasm, coma and convulsion.

How safe is Dotarem?

Is Dotarem contrast safe?

Dotarem can cause a life-threatening condition in people with advanced kidney disease. You should not receive this medicine if you have kidney disease or if you are on dialysis. Gadoterate meglumine can stay in your body for months or years after you receive this medicine.