EOVIST
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EOVIST (EOVIST).
Gadoxetic acid is a hepatocyte-specific MRI contrast agent. It is taken up by hepatocytes via organic anion transporting polypeptides (OATP1B1 and OATP1B3) and excreted into bile via multidrug resistance-associated protein 2 (MRP2). The paramagnetic gadolinium ion shortens T1 relaxation time, enhancing signal intensity in liver tissue on T1-weighted images.
| Metabolism | Gadoxetic acid is eliminated by both renal excretion (approximately 50% of dose) and biliary excretion (approximately 50% of dose). It is not metabolized. The drug undergoes active transport into hepatocytes and is excreted unchanged into bile. |
| Excretion | Primarily renal elimination: 95% of the administered dose is excreted unchanged in urine within 72 hours; less than 1% eliminated via biliary/fecal route. |
| Half-life | Terminal elimination half-life is approximately 1.5 hours (range 1.2–1.8 h) in patients with normal renal function; half-life is prolonged in renal impairment, correlating with glomerular filtration rate. |
| Protein binding | Approximately 90% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is about 0.1 L/kg (range 0.08–0.12 L/kg), indicating limited extravascular distribution and consistent with blood pool and extracellular fluid compartment. |
| Bioavailability | Not applicable; administered exclusively as an intravenous bolus injection. Oral bioavailability is 0% due to gastrointestinal instability and lack of absorption. |
| Onset of Action | Intravenous administration: enhancement of hepatic parenchymal signal occurs within 30–60 seconds post-injection; maximal liver-to-lesion contrast enhancement is achieved approximately 10–20 minutes after injection. |
| Duration of Action | The hepatobiliary phase of enhancement persists for at least 1–2 hours after injection; delayed imaging up to 2 hours is clinically recommended. No significant residual enhancement beyond 24 hours. |
0.1 mL/kg body weight (0.025 mmol Gd/kg) intravenously as a bolus injection, followed by a saline flush of at least 5 mL.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in patients with severe renal impairment (GFR < 30 mL/min/1.73 m²) or acute kidney injury. No dose adjustment recommended for mild to moderate impairment. |
| Liver impairment | No specific hepatic adjustment required; use standard dosing in Child-Pugh A, B, or C cirrhosis. |
| Pediatric use | Not approved for use in pediatric patients (safety and efficacy not established). |
| Geriatric use | No specific dose adjustment recommended; renal function should be assessed prior to use. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EOVIST (EOVIST).
| Breastfeeding | It is not known if gadoxetate disodium is excreted in human milk. However, many gadolinium-based contrast agents are excreted in breast milk in very small amounts. The manufacturer recommends a 24-hour period of breastfeeding interruption. No M/P ratio data available for Eovist. Due to potential for adverse effects in the nursing infant, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. In animal reproduction studies, intravenous administration of gadoxetate disodium during organogenesis produced no evidence of teratogenicity at doses up to 2.5 mmol/kg (approximately 2.5 times the human dose based on BSA) in rats and 0.5 mmol/kg in rabbits. Gadolinium-based contrast agents cross the placenta and are known to be present in fetal tissues. Use only if clearly needed and potential benefit justifies risk. Limited data in first trimester; avoid in second and third trimesters due to fetal gadolinium deposition risk. |
■ FDA Black Box Warning
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for 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 MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury. Screen all patients for renal dysfunction before administration.
| Serious Effects |
["History of allergic reaction to gadoxetic acid or any gadolinium-based contrast agent","Patients with chronic severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury"]
| Precautions | ["Risk of nephrogenic systemic fibrosis (NSF) in patients with impaired renal function","Acute hypersensitivity reactions (anaphylaxis) may occur","Extravasation at injection site may cause local tissue irritation","Administration may cause transient increase in serum iron and bilirubin","Use caution in patients with hepatic impairment due to reduced biliary excretion","Withhold in patients with acute kidney injury or chronic kidney disease with GFR <30 mL/min/1.73m²"] |
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| Fetal Monitoring | Monitor maternal renal function before administration due to risk of nephrogenic systemic fibrosis. During pregnancy, monitor for maternal hypotension, dyspnea, or anaphylactoid reactions. Fetal heart rate monitoring is not routine but may be considered if maternal adverse events occur. In neonates exposed in utero, monitor renal function if the mother had impaired renal function. |
| Fertility Effects | No human data on effects on fertility. In animal studies, no adverse effects on fertility or reproductive performance were observed in male or female rats at intravenous doses up to 2.5 mmol/kg (approximately 2.5 times the human dose based on BSA) for 28 days prior to mating. Clinical relevance unknown. |