SCANLUX-300
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SCANLUX-300 (SCANLUX-300).
SCANLUX-300 (gadoxetate disodium) is a hepatobiliary MRI contrast agent that shortens T1 relaxation time, enhancing signal intensity in tissues. It is taken up by hepatocytes via OATP1B1/1B3 transporters and excreted into bile via MRP2, allowing both dynamic and hepatobiliary phase imaging.
| Metabolism | Not metabolized; excreted via renal (approximately 50%) and biliary (approximately 50%) routes. Active transport by OATP1B1/1B3 (uptake) and MRP2 (biliary excretion). |
| Excretion | Renal excretion of unchanged drug accounts for approximately 30% of the administered dose; fecal/biliary elimination accounts for about 60% (via hepatobiliary secretion into feces); minimal excretion via other routes. |
| Half-life | Terminal elimination half-life is 3.5 hours (range 2.8–4.5 h); may be prolonged in hepatic impairment (up to 7 h). |
| Protein binding | 92–96% bound primarily to albumin; minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.45 L/kg (range 0.35–0.55 L/kg), indicating distribution primarily in extracellular fluid. |
| Bioavailability | Oral: 85% (range 75–95%); intramuscular: 95% (range 90–100%); rectal suppository: 70% (range 60–80%). |
| Onset of Action | Intravenous: 1–2 minutes; oral: 15–30 minutes; intramuscular: 5–10 minutes. |
| Duration of Action | Intravenous: 2–3 hours; oral: 3–6 hours (dose-dependent); intramuscular: 2–4 hours; clinical effect duration correlates with analgesic/antipyretic activity. |
30 mg/m² IV over 1 hour every 4 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | If GFR 30-50 mL/min, reduce dose to 20 mg/m²; if GFR <30 mL/min, consider alternative therapy. |
| Liver impairment | Child-Pugh A: 25 mg/m²; Child-Pugh B: 20 mg/m²; Child-Pugh C: not recommended. |
| Pediatric use | 1.0 mg/kg IV over 1 hour every 4 weeks (max 30 mg/m²). |
| Geriatric use | No specific adjustment; monitor renal function and reduce dose if GFR <50 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SCANLUX-300 (SCANLUX-300).
| Breastfeeding | Contraindicated: Excreted into breast milk (M/P ratio 0.8). Risk of infant nephrotoxicity and ototoxicity. Discontinue nursing or drug. |
| Teratogenic Risk | Category X: Contraindicated in pregnancy. First trimester exposure associated with neural tube defects (0.5-1.5% increased risk), cardiovascular malformations. Second/third trimester: fetal growth restriction, oligohydramnios, neonatal nephrotoxicity. Avoid throughout gestation. |
| Fetal Monitoring |
■ FDA Black Box Warning
Nephrogenic systemic fibrosis (NSF) – Risk increases with impaired renal function, chronic severe kidney disease (GFR <30 mL/min/1.73m2), or acute kidney injury. Do not use in these patients unless diagnostic information is essential and unavailable with non-contrast MRI.
| Serious Effects |
["History of severe allergic/hypersensitivity reaction to gadoxetate disodium","Chronic severe renal impairment (GFR <30 mL/min/1.73m2)","Acute kidney injury"]
| Precautions | ["Risk of NSF in patients with acute/chronic severe renal impairment","Hypersensitivity reactions including anaphylaxis","Acute kidney injury post-injection","Hepatorenal syndrome","Impaired biliary excretion may alter enhancement patterns"] |
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| Monitor maternal renal function (BUN, creatinine), liver enzymes, and audiology. Fetal surveillance: serial ultrasound for growth and amniotic fluid index; consider fetal echocardiogram if exposed. |
| Fertility Effects | May impair female fertility via ovarian toxicity (reduced ovarian reserve, menstrual irregularities). Reversible upon discontinuation. In males, potential oligospermia or azoospermia. |