Gadoversetamide

Gadoversetamide is a gadolinium-based paramagnetic contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use:

• In patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues
• To provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomograph

Gadoversetamide is a paramagnetic agent that develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment can enhance the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.

Bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg). Follow injection with a 5 mL normal saline flush. Complete imaging procedure within 1 hour of injection

Drug interactions with other contrast agents and other drugs have not been studied.

Chronic, severe kidney disease (glomerular filtration rate, GFR<30 mL/min/1.73m2), acute kidney injury. Prior hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients

Most common adverse reactions (incidence >2%) are: headache, vasodilatation, taste perversion, dizziness, nausea and paresthesia.

use Gadoversetamide only if imaging is essential during pregnancy and cannot be delayed. Radiolabeled gadoversetamide (153Gd) was excreted in the milk of lactating rats receiving a single intravenous dose of 0.1 mmol/kg. Women should discontinue nursing and discard breast milk up to 72 hours after Gadoversetamide administration

Nephrogenic Systemic Fibrosis (NSF) has occurred in patients with impaired elimination of Gadolinium Based Contrast Agents (GBCAs). Higher than recommended dosing or repeat dosing appears to increase the risk.

Hypersensitivity reactions including fatal reactions have occurred, particularly in patients with history of allergy, drug reactions, or other hypersensitivity-like disorders. Monitor these patients closely during and after administration of gadoversetamide.

Gadolinium is retained for months or years in brain, bone, and other organs. 

Acute Kidney Injury (AKI) has occurred in patients with preexisting renal insufficiency. Use the lowest necessary dose of gadoversetamide in these patients.

Interference with laboratory measurements of serum iron, copper and zinc and in the measurement of serum calcium using the ortho-cresophthalin complexone (OCP) colorimetric method has occurred.

Pediatric Use: The safety and effectiveness of Gadoversetamide in pediatric patients have not been established. Pediatric patients may be particularly vulnerable to adverse GBCA reactions due to renal immaturity or unrecognized renal insufficiency.

Geriatric Use: Since gadoversetamide is cleared from the body by glomerular filtration, the risk of adverse reactions may be greater in patients with impaired renal function (GFR ≥30 and <90 mL/min/1.73m2). Due to the risk for NSF, estimate the GFR through laboratory testing for patients >60 years of age

Clinical consequences of overdosage with Gadoversetamide have not been reported. Treatment of overdose is directed toward supporting vital functions and prompt institution of symptomatic therapy. Gadoversetamide has been shown to be dialyzable

Contrast medium for diagnostic procedures

Gadoversetamide should be stored at 20°C to 25°C and protected from light and freezing. Gadoversetamide may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C