gadoxetate (Eovist, Gadoxetic Acid)

Dosing and uses of Eovist, Gadoxetic Acid (gadoxetate)

• Adult
• Pediatric

 

Adult dosage forms and strengths

injectable solution

• 0.25 mol/L

 

MRI of Liver Lesions

0.1 mL/kg (0.025 mmol/kg) IV bolus; not to exceed infusion rate of 10 mL/15 seconds

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Warnings

Black box warnings

Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73 sq.m, hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant

NSF affects internal organs, skin, and muscle and can be fataL

Only use if essential and MRI cannot not provide appropriate diagnostic image

Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses

 

Contraindications

Hypersensitivity; history of allergy/drug reactions

 

Cautions

Caution in thrombotic syndromes; anemia, hepatic impairment; hemoglobinopathies (sickle cell anemia); history of grand mal seizure

In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis reported with the use of some gadolinium-based contrast agents; risk of acute kidney injury might be lower with gadoxetate due to its dual excretory pathways; do not exceed recommended dose

Risk for nephrogenic systemic fibrosis (NSF) in patients w/ acute or chronic severe renal insufficiency, hepatorenal syndrome or in perioperative liver transplantation period

Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with use of gadolinium contrast media in patients with kidney disease; do not exceed recommended dose

Risk of hypotension

Tissue damage/reactions reported with extravasation

Brain deposits

• 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
• Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
• It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
• Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Not known whether excreted in breast milk, use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Eovist, Gadoxetic Acid (gadoxetate)

Mechanism of action

Paramagnetic agent; exposure to external magnetic field in gadopentetate may induce a large magnetic field. The local magnetism may change proton density and spin characteristics, which it is then detected by the imaging device

 

Pharmacokinetics

Half-life: 0.91-0.95 hr

Excretion: Urine, feces

Vd: 0.21 L/kg

Protein binding: <10%