MAGNEVIST
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MAGNEVIST (MAGNEVIST).
Gadopentetate dimeglumine is a paramagnetic contrast agent that shortens T1 and T2 relaxation times in tissues where it accumulates, enhancing signal intensity on T1-weighted magnetic resonance imaging (MRI). It distributes extracellularly and does not cross the intact blood-brain barrier, but accumulates in areas of disrupted barrier or abnormal vascularity.
| Metabolism | Gadopentetate dimeglumine is not metabolized. It is eliminated unchanged by glomerular filtration with a half-life of approximately 1.3 hours in patients with normal renal function. |
| Excretion | Renal excretion of unchanged gadopentetate dimeglumine accounts for approximately 99% of the administered dose within 72 hours. Biliary/fecal excretion is negligible (<0.5%). |
| Half-life | Terminal elimination half-life in patients with normal renal function is approximately 1.6 hours. In patients with impaired renal function, half-life is prolonged (up to 30 hours with GFR <30 mL/min). |
| Protein binding | No significant protein binding (0-2%). |
| Volume of Distribution | Volume of distribution is approximately 0.23 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Magnevist is administered intravenously; bioavailability is 100% by this route. |
| Onset of Action | Immediately upon intravenous injection; contrast enhancement is observed within minutes following administration. |
| Duration of Action | Contrast enhancement persists for approximately 30-60 minutes after injection, sufficient for most MRI sequences. Rapid redistribution and renal clearance limit duration. |
0.2 mL/kg (0.1 mmol/kg) intravenously, up to 0.6 mL/kg (0.3 mmol/kg) for certain indications, with a maximum of 20 mL per dose.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min/1.73 m²: contraindicated (risk of nephrogenic systemic fibrosis). For GFR 30–59 mL/min/1.73 m²: use lowest effective dose and avoid repeated administration. |
| Liver impairment | No specific Child-Pugh based adjustments; use caution in severe hepatic impairment due to potential gadolinium retention. |
| Pediatric use | Children (2–18 years): 0.2 mL/kg (0.1 mmol/kg) IV, maximum 20 mL. Neonates and infants <2 years: use only if clearly needed, with same weight-based dosing. |
| Geriatric use | No specific dose adjustment, but assess renal function and avoid use if GFR <30 mL/min/1.73 m²; lower doses may be appropriate given age-related renal decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MAGNEVIST (MAGNEVIST).
| Breastfeeding | Gadopentetate dimeglumine is excreted into human breast milk in very low amounts (M/P ratio not established; estimated <0.04% of maternal dose). The American College of Radiology recommends that breastfeeding may be continued without interruption after receiving a standard dose. If concerned, pump and discard milk for 24 hours. |
| Teratogenic Risk | Gadopentetate dimeglumine crosses the placenta. In animal studies, no teratogenic effects were observed at doses up to 2.5 mmol/kg/day. However, gadolinium-based contrast agents are known to accumulate in fetal tissues. Use only if imaging is essential and benefits outweigh risks. First trimester: avoid unless critical. Second/third trimester: limited data, use with caution. Postnatal risk: gadolinium deposition in fetal organs is a concern. |
■ 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 unless diagnostic information is essential and not available with non-contrast MRI. Screen all patients for renal dysfunction before use.
| Serious Effects |
["History of severe hypersensitivity reaction to gadopentetate dimeglumine or any of its components","Patients with acute or chronic severe renal insufficiency (GFR <30 mL/min/1.73m²) or acute kidney injury, unless the benefit clearly outweighs the risk and non-contrast MRI is not an option"]
| Precautions | ["Risk of nephrogenic systemic fibrosis (NSF) in patients with severe renal impairment","Acute adverse reactions including anaphylaxis, hypotension, and respiratory distress","Extravasation may cause local tissue irritation and necrosis","Increased risk in patients with history of allergic reactions, asthma, or other hypersensitivity disorders"] |
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| Fetal Monitoring | Monitor for hypersensitivity reactions (urticaria, anaphylaxis) during and after administration. Assess renal function before use due to risk of nephrogenic systemic fibrosis. In pregnancy, monitor for any adverse maternal or fetal effects; no specific fetal monitoring required beyond routine prenatal care. |
| Fertility Effects | No known effect on fertility in animal studies. No human data available. The drug is not expected to impair reproductive function based on its pharmacological profile. |