DOTAREM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DOTAREM (DOTAREM).
Gadoterate meglumine is a paramagnetic contrast agent that increases signal intensity in magnetic resonance imaging (MRI) by shortening the T1 relaxation time of protons in tissues, primarily due to the gadolinium ion (Gd3+) with seven unpaired electrons. It distributes into extracellular spaces and is eliminated renally.
| Metabolism | Gadoterate meglumine is not metabolized. It is excreted unchanged by the kidneys via glomerular filtration with a half-life of approximately 1.5 hours in patients with normal renal function. |
| Excretion | Primarily renal excretion via glomerular filtration; 95% excreted unchanged in urine within 24 hours, with approximately 85% eliminated in the first 4 hours. Less than 1% excreted via feces. No biliary excretion. |
| Half-life | Terminal elimination half-life is approximately 1.5–2.5 hours in patients with normal renal function (GFR >60 mL/min/1.73 m²). In renal impairment, half-life is prolonged: 4–6 hours in moderate impairment (GFR 30–59 mL/min/1.73 m²), and up to 18–24 hours in severe impairment (GFR <30 mL/min/1.73 m²). |
| Protein binding | Negligible protein binding (<1%, primarily to albumin). |
| Volume of Distribution | Volume of distribution is approximately 0.2–0.25 L/kg (15–20 L in a 70 kg adult), consistent with distribution primarily in extracellular fluid. |
| Bioavailability | Not applicable (administered only intravenously). Bioavailability is 100% via IV route. |
| Onset of Action | Intravenous administration: Onset of enhancement occurs immediately after injection. Maximal contrast enhancement in cerebral vasculature appears within the first minute, and in CNS lesions within 2–5 minutes post-injection. |
| Duration of Action | Duration of contrast enhancement for MRI imaging is approximately 30–90 minutes post-injection, sufficient for diagnostic imaging sequences. Clinical utility window is typically 15–60 minutes. |
Adult dose: 0.2 mL/kg (0.1 mmol/kg) IV bolus; second dose may be given within 30 minutes for MRI.
| Dosage form | SOLUTION |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59: reduce dose to 0.1 mL/kg (0.05 mmol/kg); GFR <30: avoid use (contraindicated). |
| Liver impairment | No specific Child-Pugh based adjustment required; use standard dosing with caution. |
| Pediatric use | 2 weeks to 17 years: 0.2 mL/kg (0.1 mmol/kg) IV bolus; maximum 20 mL per dose. |
| Geriatric use | No specific adjustment; consider renal function and use lowest effective dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DOTAREM (DOTAREM).
| Breastfeeding | Gadoterate is excreted in breast milk in very low concentrations (estimated relative infant dose <0.04% of maternal dose). M/P ratio not determined. Guidelines suggest breastfeeding can continue without interruption after gadolinium administration; however, the manufacturer recommends discontinuing breastfeeding for 24 hours to minimize any potential risk. |
| Teratogenic Risk | Gadoterate meglumine crosses the placenta and is associated with fetal gadolinium deposition. In animal studies, no teratogenic effects were observed at clinically relevant doses. However, human data are limited; therefore, use only if clearly needed and if benefits justify potential fetal risk. First trimester: avoid unless essential; second and third trimesters: risk of fetal gadolinium accumulation unknown but may be associated with neonatal adverse events. |
■ FDA Black Box Warning
Gadolinium-based contrast agents (GBCAs) increase the risk of nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (GFR < 30 mL/min/1.73m²) or acute kidney injury from hepatorenal syndrome or perioperative liver transplantation. Avoid use unless diagnostic information is essential.
| Serious Effects |
["History of severe hypersensitivity reaction to gadoterate meglumine or any GBCA","Acute or chronic severe renal insufficiency (GFR < 30 mL/min/1.73m²) unless dialysis is initiated immediately","Acute kidney injury due to hepatorenal syndrome or perioperative liver transplantation"]
| Precautions | ["Nephrogenic systemic fibrosis (NSF) risk in patients with severe renal impairment","Hypersensitivity reactions (anaphylaxis, urticaria, bronchospasm)","Acute kidney injury requiring dialysis in patients with pre-existing renal impairment","Extravasation: local tissue injury","Hematologic abnormalities (sickle cell disease: vaso-occlusive crises)","Interference with serum calcium measurements (chelating effect)","Pregnancy: use only if benefits outweigh risks (no adequate studies)"] |
Loading safety data…
| Fetal Monitoring | No specific maternal-fetal monitoring required. Standard precautions for contrast administration (e.g., renal function assessment, history of allergic reaction). In pregnancy, consider fetal monitoring if maternal hypotension or adverse reaction occurs. |
| Fertility Effects | No adverse effects on fertility observed in animal studies. Human data lacking. |