SCANLUX-370
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SCANLUX-370 (SCANLUX-370).
Radiopaque contrast agent that contains iodine, attenuates X-rays, enhancing vascular and tissue visualization during imaging.
| Metabolism | Not metabolized; excreted unchanged via glomerular filtration. |
| Excretion | SCANLUX-370 is primarily eliminated via renal excretion, with approximately 85-90% of the dose recovered unchanged in urine within 24 hours. The remaining 10-15% is excreted unchanged in feces via biliary elimination. |
| Half-life | The terminal elimination half-life of SCANLUX-370 is approximately 1.5-2 hours in patients with normal renal function. This short half-life allows for rapid clearance and minimal accumulation with repeated dosing. |
| Protein binding | SCANLUX-370 exhibits negligible protein binding, with less than 5% bound to plasma proteins, primarily albumin. The low binding ensures rapid distribution and clearance. |
| Volume of Distribution | The volume of distribution (Vd) is approximately 0.25-0.3 L/kg, indicating distribution primarily within the extracellular fluid space. This low Vd reflects limited tissue penetration, consistent with its use as an extracellular contrast agent. |
| Bioavailability | SCANLUX-370 is administered intravenously and has 100% bioavailability via this route. Oral bioavailability is negligible (less than 1%) due to poor gastrointestinal absorption and extensive first-pass metabolism. |
| Onset of Action | After intravenous administration, the onset of action for contrast enhancement occurs within seconds, with peak enhancement achieved at 1-2 minutes post-injection. |
| Duration of Action | The duration of contrast enhancement is short, typically lasting 5-10 minutes for vascular phase imaging. For delayed imaging, enhancement may persist up to 30 minutes in tissues with abnormal vascular permeability. |
The typical adult dose of SCANLUX-370 is 0.1 mg/kg administered intravenously as a single dose, up to a maximum of 7 mg.
| Dosage form | INJECTABLE |
| Renal impairment | For patients with GFR 30-60 mL/min: reduce dose by 50%. For GFR <30 mL/min: use is contraindicated. |
| Liver impairment | Child-Pugh Class A: no adjustment. Class B: reduce dose by 25%. Class C: use with caution, maximum dose 0.05 mg/kg. |
| Pediatric use | For children aged 2-12 years: 0.05 mg/kg intravenously, max 3 mg. For infants 6-24 months: 0.03 mg/kg, max 1.5 mg. |
| Geriatric use | No specific dose adjustment required, but monitor renal function; consider starting at the lower end of the dosing range due to age-related decline in renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SCANLUX-370 (SCANLUX-370).
| Breastfeeding | Ioxaglate is excreted into breast milk in minimal amounts; M/P ratio not established. Theoretical risk of direct iodine exposure to infant; consider interrupting breastfeeding for 12-24 hours post-dose with pumping and discarding milk. Infant monitoring for thyroid function not routinely required but caution advised. |
| Teratogenic Risk | Iodinated contrast media, including ioxaglate (SCANLUX-370), cross the placenta. First trimester exposure: Theoretical risk of fetal thyroid dysfunction from excess iodine; no documented teratogenicity in human studies. Second and third trimester: Can cause transient neonatal hypothyroidism if administered near term; avoid unless essential. Use only when diagnostic benefit outweighs potential risk. |
■ FDA Black Box Warning
Risk of acute renal failure, particularly in patients with pre-existing renal impairment, diabetes mellitus, or dehydration.
| Serious Effects |
["Hypersensitivity to iodinated contrast media","Severe renal impairment (eGFR < 30 mL/min/1.73 m²)","Concurrent use of metformin in patients with renal dysfunction","Known thyrotoxicosis"]
| Precautions | ["Acute renal failure","Anaphylactic/anaphylactoid reactions","Thyroid dysfunction in predisposed patients","Extravasation leading to tissue necrosis","Sickle cell disease exacerbation"] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine) before administration due to risk of contrast-induced nephropathy. Assess fetal heart rate and uterine activity if contrast given during pregnancy. Post-contrast: Monitor newborn for signs of hypothyroidism (TSH screening at birth) if administered near delivery. |
| Fertility Effects | No known adverse effects on fertility in animal studies or human reports. Theoretical risk of ovarian damage from radiation exposure if combined with X-ray; isolated contrast media unlikely to affect fertility. |