PROHANCE MULTIPACK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PROHANCE MULTIPACK (PROHANCE MULTIPACK).
Gadoteridol is a paramagnetic gadolinium-based contrast agent that shortens T1 relaxation time in tissues, enhancing signal intensity on magnetic resonance imaging (MRI).
| Metabolism | Gadoteridol is not metabolized; it is eliminated unchanged primarily by glomerular filtration. |
| Excretion | Renal: 95% unchanged in urine within 24 hours; biliary/fecal: <0.1% |
| Half-life | 1.5-2.5 hours (normal renal function); prolonged to 10-30 hours in severe renal impairment |
| Protein binding | Negligible (<0.1%) |
| Volume of Distribution | 0.2-0.3 L/kg; indicates distribution primarily in extracellular fluid |
| Bioavailability | 100% (intravenous only; no oral formulation) |
| Onset of Action | Immediate after intravenous injection; enhances contrast within seconds |
| Duration of Action | Sufficient for imaging (~1 hour); excretion complete by 24 hours |
0.1 mmol/kg (0.2 mL/kg) intravenous bolus; maximum 0.3 mmol/kg per imaging session.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-59 mL/min/1.73 m2: 0.1 mmol/kg; GFR <30 mL/min/1.73 m2 or on dialysis: contraindicated due to risk of nephrogenic systemic fibrosis. |
| Liver impairment | No dose adjustment required for Child-Pugh A, B, or C; use standard dose with caution. |
| Pediatric use | Neonates (0-1 month): 0.1 mmol/kg IV; Children (1 month-18 years): 0.1 mmol/kg IV; off-label double dose (0.2 mmol/kg) may be considered for specific central nervous system indications. |
| Geriatric use | Start at lowest effective dose (0.1 mmol/kg); assess renal function before administration; avoid in patients with chronic severe kidney disease (eGFR <30 mL/min/1.73 m2). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PROHANCE MULTIPACK (PROHANCE MULTIPACK).
| Breastfeeding | Gadolinium is excreted into breast milk in minimal amounts (M/P ratio approximately 0.23). The systemic absorption in the infant is negligible, but the manufacturer advises discontinuing breastfeeding for 24 hours after administration due to potential adverse effects. Based on limited data, the risk to the infant is considered low, but caution is warranted. |
| Teratogenic Risk | Gadolinium-based contrast agents cross the placenta and are associated with an increased risk of nephrogenic systemic fibrosis in neonates. In animal studies, no teratogenic effects were observed at clinically relevant doses. Use during pregnancy is contraindicated unless the potential benefit outweighs the risk. There is no evidence of fetal harm from single exposures in the first trimester, but repeated exposure or high cumulative doses may increase risk. |
■ FDA Black Box Warning
Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (GFR <30 mL/min/1.73m²) or hepatorenal syndrome. Avoid use in these patients unless the diagnostic information is essential and not available with non-contrast MRI.
| Serious Effects |
["Hypersensitivity to gadoteridol or any component of the formulation","Acute or chronic severe renal insufficiency (GFR <30 mL/min/1.73m²)","Hepatorenal syndrome or liver transplant recipients (risk of NSF)"]
| Precautions | ["Risk of NSF in patients with renal impairment","Acute adverse reactions including anaphylaxis and hypersensitivity","Gadolinium retention in brain and other tissues with repeated use","Use caution in patients with history of allergic disorders or asthma"] |
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| Fetal Monitoring | Monitor maternal renal function prior to administration due to risk of nephrogenic systemic fibrosis. No specific fetal monitoring is required; however, consider fetal assessment if multiple exposures occur. Assess for signs of allergic reaction during and after administration. |
| Fertility Effects | Animal studies have not shown impaired fertility at clinically relevant doses. No human data on fertility effects are available. |