MULTIHANCE MULTIPACK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MULTIHANCE MULTIPACK (MULTIHANCE MULTIPACK).
Gadobenate dimeglumine is a paramagnetic contrast agent that enhances magnetic resonance imaging by increasing the relaxation rate of water protons in tissues where it accumulates. The gadolinium ion (Gd3+) shortens T1 and T2 relaxation times, leading to increased signal intensity on T1-weighted images.
| Metabolism | Gadobenate dimeglumine is not significantly metabolized, as it is an inert gadolinium chelate. The drug is excreted unchanged primarily via the kidneys, with approximately 95% of the dose eliminated in urine within 24 hours. Less than 5% is eliminated via the biliary route. |
| Excretion | Renal excretion: 95% unchanged drug via glomerular filtration; biliary/fecal: <0.1% |
| Half-life | Terminal elimination half-life: 1.5–2.2 hours in patients with normal renal function; prolonged (up to 30 hours) in severe renal impairment (eGFR <30 mL/min/1.73m²) |
| Protein binding | <10% bound to plasma proteins (mainly albumin) |
| Volume of Distribution | 0.25–0.3 L/kg, indicating distribution primarily in extracellular fluid |
| Bioavailability | Intravenous: 100% (only route of administration) |
| Onset of Action | Intravenous: immediate enhancement of magnetic resonance imaging signal intensity within seconds of injection |
| Duration of Action | Intravenous: diagnostic window of approximately 45–60 minutes for standard imaging protocols |
0.1 mmol/kg body weight (0.2 mL/kg) intravenous bolus injection; maximum single dose 0.3 mmol/kg (0.6 mL/kg)
| Dosage form | INJECTABLE |
| Renal impairment | eGFR 30-59 mL/min/1.73m²: 0.1 mmol/kg; eGFR <30 mL/min/1.73m²: contraindicated; or administer 0.1 mmol/kg as a single dose, do not administer second dose within 7 days |
| Liver impairment | No specific dose adjustment recommended; use caution in severe hepatic impairment |
| Pediatric use | Neonates and infants <2 years: 0.1 mmol/kg body weight (0.2 mL/kg); children 2-18 years: 0.1 mmol/kg body weight, maximum 0.2 mL/kg; do not exceed recommended dose |
| Geriatric use | No specific dose adjustment; consider renal function based on eGFR due to age-related decline |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MULTIHANCE MULTIPACK (MULTIHANCE MULTIPACK).
| Breastfeeding | Very small amount excreted in breast milk (<0.04% of maternal dose). M/P ratio not established. American College of Radiology recommends breastfeeding can continue without interruption after contrast administration; however, some guidelines suggest discarding milk for 24 hours post-dose. |
| Teratogenic Risk | Gadolinium-based contrast agents cross the placenta. First trimester: Avoid due to organogenesis risk; animal studies show fetal abnormalities at high doses. Second/third trimester: Use only if essential; gadolinium accumulates in fetal kidneys and amniotic fluid with prolonged half-life. Postnatal risk of nephrogenic systemic fibrosis (NSF) in neonates is theoretical. |
■ FDA Black Box Warning
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrast MRI. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk appears highest for patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m²) as well as those with acute kidney injury. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age >60 years, hypertension, diabetes), estimate the GFR through laboratory testing.
| Serious Effects |
["Known hypersensitivity to gadobenate dimeglumine or any components of the formulation","History of allergic or hypersensitivity reaction to other gadolinium-based contrast agents","Severe renal impairment (GFR <30 mL/min/1.73m²) or acute kidney injury, unless diagnostic need is essential and non-contrast imaging is inadequate"]
| Precautions | ["Nephrogenic Systemic Fibrosis (NSF): Risk increased in patients with chronic kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury.","Acute adverse reactions: Hypersensitivity reactions including anaphylaxis, bronchospasm, laryngeal edema, and cardiovascular reactions may occur.","Gadolinium retention: Linear GBCAs deposit gadolinium in tissues, including brain, bone, and skin. Clinical significance unknown.","Renal impairment: Dose adjustment and careful monitoring required; use lowest effective dose.","Interference with serum calcium measurements: May falsely lower serum calcium when using certain colorimetric methods."] |
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| Fetal Monitoring | Monitor maternal renal function (eGFR) before administration to assess NSF risk. Fetal exposure minimized by using lowest effective dose. No specific fetal monitoring required, but assess need for postnatal renal function in neonates if multiple exposures occurred. |
| Fertility Effects | No evidence of adverse effects on fertility in animal studies. Human data limited; no expected impact on reproductive function. |