CLARISCAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLARISCAN (CLARISCAN).
Gadoteridol is a paramagnetic gadolinium-based contrast agent (GBCA) that shortens T1 and T2 relaxation times in tissues, enhancing signal intensity in magnetic resonance imaging (MRI).
| Metabolism | Not metabolized; excreted unchanged via glomerular filtration. Half-life: ~1.5 hours in normal renal function; prolonged in renal impairment. |
| Excretion | Renal: 95% as unchanged drug; biliary/fecal: 5%. |
| Half-life | Terminal elimination half-life: 1.5-2 hours (normal renal function); prolonged to 10-30 hours in severe renal impairment (creatinine clearance <30 mL/min). |
| Protein binding | Negligible (<5%), not bound significantly to plasma proteins. |
| Volume of Distribution | 0.2-0.3 L/kg; indicates distribution primarily in extracellular fluid. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate (seconds to minutes); oral: not applicable (parenteral only). |
| Duration of Action | IV: 30-60 minutes for clinical imaging effect (enhancement peaks at 1-2 minutes, declines rapidly). |
0.1 mL/kg (0.2 mmol/kg) intravenous bolus, up to 20 mL.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-59 mL/min: 0.1 mL/kg. GFR <30 mL/min: contraindicated; use alternative agent. Dialysis: not removed. |
| Liver impairment | No adjustment required. |
| Pediatric use | 0.2 mL/kg (0.4 mmol/kg) intravenous bolus, not to exceed 20 mL. For children <2 years: 0.2 mL/kg. |
| Geriatric use | Same as standard dosing; monitor renal function; consider reduced dose if GFR <30 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLARISCAN (CLARISCAN).
| Breastfeeding | Gadoterate meglumine is excreted into human breast milk in very small amounts. The M/P ratio is not established. The amount absorbed by the infant is negligible (<0.04% of the maternal dose). Breastfeeding can be continued without interruption after administration; however, some sources suggest discarding milk for 12-24 hours post-contrast as a precaution. |
| Teratogenic Risk | CLARISCAN (gadoterate meglumine) is a gadolinium-based contrast agent. In animal studies, no teratogenic effects were observed at doses up to 2.5 times the human dose. Human data are limited; however, gadolinium agents cross the placenta and may accumulate in fetal tissues. The risk is considered low with single doses. Use in all trimesters only if clearly needed and benefit outweighs potential unknown fetal risks. |
■ FDA Black Box Warning
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (GFR <30 mL/min/1.73m²) or acute kidney injury. Avoid use in these patients unless diagnostic information is essential and not available with non-contrast MRI.
| Serious Effects |
["History of hypersensitivity reaction to gadoteridol or any other GBCA","Severe renal insufficiency (GFR <30 mL/min/1.73m²) unless dialysis is initiated promptly after administration","Acute kidney injury"]
| Precautions | ["Risk of nephrogenic systemic fibrosis (NSF) in patients with severe renal impairment","Gadolinium retention: small amounts may remain in tissues (brain, bone, skin) for months or years; clinical significance unknown","Acute adverse reactions including anaphylaxis, hypotension, respiratory distress","Nephrotoxicity in patients with pre-existing renal disease","Interference with serum calcium measurements using certain colorimetric methods"] |
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| Fetal Monitoring | No specific maternal or fetal monitoring is required. Standard monitoring during contrast administration includes observation for allergic reactions. For pregnant patients, fetal heart rate monitoring is not routinely indicated but may be considered based on gestational age and clinical scenario. |
| Fertility Effects | No known effects on human fertility. Animal studies have not shown impairment of fertility at clinically relevant doses. |