BILIVIST
Clinical safety rating
cautionComprehensive clinical and safety monograph for BILIVIST (BILIVIST).
Bilivist (gadoxetate disodium) is a hepatobiliary MRI contrast agent. It is taken up by hepatocytes via organic anion transporting polypeptides (OATP1B1/1B3) and excreted into bile via multidrug resistance-associated protein 2 (MRP2). This dual renal and biliary excretion provides both dynamic and hepatocyte-specific imaging.
| Metabolism | Not metabolized. Eliminated via renal (approximately 50%) and biliary (approximately 50%) routes. |
| Excretion | Primarily renal (glomerular filtration) as unchanged drug; ~95% excreted in urine within 24 hours; <5% biliary/fecal. |
| Half-life | Terminal elimination half-life approximately 12 hours; clinically relevant for imaging timing and renal function adjustment. |
| Protein binding | <10% bound to plasma proteins (mainly albumin). |
| Volume of Distribution | Approximately 0.15–0.20 L/kg; distributes primarily in extracellular fluid. |
| Bioavailability | Not applicable (administered only intravenously); 100% bioavailability by IV route. |
| Onset of Action | Intravenous: within 5 minutes post-contrast injection. |
| Duration of Action | Sufficient for hepatobiliary imaging (up to 60 minutes post-injection); biliary excretion begins within 10-20 minutes. |
| Molecular Weight | 846.3 Da |
0.1 mL/kg (0.25 mmol Gd/kg) intravenously, single dose.
| Dosage form | CAPSULE |
| Renal impairment | Contraindicated in acute kidney injury or chronic severe renal impairment (GFR < 30 mL/min/1.73 m²). No dose adjustment recommended for mild to moderate impairment (GFR ≥ 30 mL/min/1.73 m²). |
| Liver impairment | No specific dosing adjustment for hepatic impairment; use with caution in severe impairment due to potential gadolinium retention. |
| Pediatric use | Not approved for patients under 18 years of age; efficacy and safety not established. |
| Geriatric use | No specific dose adjustment; consider renal function as age-related decline may increase risk of nephrogenic systemic fibrosis (NSF). |
| 1st trimester | Contraindicated due to risk of fetal harm from iodine exposure; may cause fetal thyroid dysfunction. |
| 2nd trimester | Contraindicated; alternative imaging preferred. Use only if benefit outweighs risk of fetal hypothyroidism. |
| 3rd trimester | Contraindicated; may cause neonatal hypothyroidism. Avoid unless essential for maternal diagnosis. |
Clinical note
Comprehensive clinical and safety monograph for BILIVIST (BILIVIST).
| Placental transfer | Crosses placenta; documented transfer of iodine-based contrast agents with risk of fetal thyroid suppression. |
| Breastfeeding | Excreted into breast milk in small amounts; iodine content may cause infant thyroid suppression. Discontinue breastfeeding or avoid use, especially in neonates with underlying thyroid conditions. |
| Lactation Rating | L4 (Possibly Hazardous) |
| Teratogenic Risk | BILIVIST (gadoxetate disodium) is a gadolinium-based contrast agent (GBCA). Gadolinium crosses the placenta and accumulates in fetal tissues. There are no adequate studies in pregnant women; however, animal studies have shown adverse effects at high doses. The risk of nephrogenic systemic fibrosis (NSF) from gadolinium exposure is theoretical in the fetus. Use in pregnancy only if clearly needed and after careful risk-benefit assessment. The highest risk is in the first trimester during organogenesis, but the agent should be avoided in all trimesters unless essential. |
| Fetal Monitoring | No specific fetal monitoring is required. Evaluate maternal renal function before administration due to risk of NSF. Monitor for hypersensitivity reactions during and after injection. No specific fetal heart rate or ultrasound monitoring is indicated. If inadvertently administered during pregnancy, consider a neonatal evaluation for potential gadolinium retention. |
| Fertility Effects | No adequate data on fertility effects. Animal studies have not revealed impaired fertility. Reversible effects on male reproductive organs were observed in rats at high doses, but clinical relevance in humans is unknown. No specific effects on female fertility have been reported. |
■ FDA Black Box Warning
Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m²) or acute kidney injury due to hepatorenal syndrome or in the perioperative liver transplantation period.
| Serious Effects |
Hypersensitivity to iodipamide or any componentSevere hepatic impairment (Child-Pugh C)HyperthyroidismAnuria or severe renal impairment (eGFR <30 mL/min/1.73 m²)
| Precautions | Risk of nephrogenic systemic fibrosis in patients with severe renal impairment, Hypersensitivity reactions including anaphylaxis, Acute kidney injury risk in patients with preexisting renal impairment, Injection site reactions, extravasation, Potential for false-positive diagnostic interpretation |
| Food/Dietary | No specific food interactions. Fasting is not required. Encourage hydration before and after administration to promote renal elimination. |
| Clinical Pearls | BILIVIST (gadoxetate disodium) is a hepatobiliary MRI contrast agent used for focal liver lesion detection. Its dual elimination (renal and biliary) allows for dynamic and hepatobiliary phase imaging. Administer as a bolus at 0.025 mmol/kg. Transient dyspnea or respiratory distress may occur during injection; monitor patient. Use with caution in severe renal impairment (eGFR <30 mL/min) due to risk of nephrogenic systemic fibrosis. Avoid rapid injection; preferred rate is 1 mL/sec. |
| Patient Advice | This medication is given intravenously before an MRI to help visualize liver lesions. · Inform your doctor if you have kidney disease, diabetes, or previous allergic reactions to contrast agents. · You may experience a brief sensation of shortness of breath or chest tightness during injection; this usually resolves quickly. · Drink plenty of water before and after the procedure to help eliminate the contrast agent. · Tell your doctor if you are pregnant, breastfeeding, or planning to become pregnant. |
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