MULTIHANCE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MULTIHANCE (MULTIHANCE).
Gadobenate dimeglumine is a paramagnetic contrast agent that increases signal intensity in magnetic resonance imaging (MRI) by shortening T1 relaxation times in tissues where it accumulates, primarily due its gadolinium content.
| Metabolism | Gadobenate dimeglumine is not metabolized; it is excreted unchanged via the kidneys by glomerular filtration. |
| Excretion | Renal: 95-100% (glomerular filtration) within 72 hours; fecal: <0.1% |
| Half-life | Terminal elimination half-life: 2.0 hours in patients with normal renal function (creatinine clearance >60 mL/min); prolonged to up to 30 hours in end-stage renal disease |
| Protein binding | <10% bound to plasma proteins (primarily albumin) |
| Volume of Distribution | 0.22-0.29 L/kg (approximately 15-20 L in adults); confined primarily to extracellular fluid |
| Bioavailability | Not applicable (administered intravenously only); oral bioavailability negligible (gadolinium chelate not absorbed orally) |
| Onset of Action | Intravenous: Immediate enhancement of signal intensity on T1-weighted MR images within seconds; peak enhancement at approximately 1-2 minutes post-injection |
| Duration of Action | Sufficient for diagnostic imaging (typically up to 1-2 hours); significant enhancement maintained for at least 30-60 minutes; prolonged in renal impairment |
0.1 mmol/kg (0.2 mL/kg) IV as a single bolus injection; maximum dose 0.3 mmol/kg (0.6 mL/kg) for CNS imaging.
| Dosage form | INJECTABLE |
| Renal impairment | GFR ≥30 mL/min: no adjustment. GFR 15-29 mL/min: 0.05 mmol/kg (0.1 mL/kg) IV; do not exceed 0.1 mmol/kg per dose. GFR <15 mL/min or dialysis: contraindicated per FDA; use only if essential with lowest possible dose and prompt dialysis. |
| Liver impairment | No specific adjustment recommended; use caution in severe hepatic impairment due to prolonged elimination. |
| Pediatric use | 0.1 mmol/kg (0.2 mL/kg) IV for children ≥2 years; safety for <2 years not established. |
| Geriatric use | No specific dose adjustment; assess renal function as age-related decline may warrant use of lower doses per renal adjustment criteria. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MULTIHANCE (MULTIHANCE).
| Breastfeeding | Minimal excretion into breast milk; the M/P ratio is approximately 0.01-0.02. Most guidelines recommend continuing breastfeeding after contrast administration, though some suggest pumping and discarding milk for 24 hours. |
| Teratogenic Risk | First trimester: Limited data; gadolinium-based contrast agents cross the placenta and are associated with potential fetal harm. Second and third trimesters: Gadolinium accumulation in fetal tissues, including kidneys, with unknown long-term effects; MRI with contrast should be avoided unless essential. The FDA categorizes gadolinium-based agents as pregnancy category C. |
■ 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 drugs. High risk patients include those with chronic, severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.
| Serious Effects |
["Patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m²) or acute kidney injury.","History of severe hypersensitivity reaction to gadobenate dimeglumine or any gadolinium-based contrast agent."]
| Precautions | ["Risk of nephrogenic systemic fibrosis (NSF) in patients with advanced renal impairment.","Acute hypersensitivity reactions including anaphylaxis.","Retention of gadolinium for months or years in brain, bone, and other organs.","Acute kidney injury in patients with pre-existing renal insufficiency.","Interference with serum calcium measurement by some colorimetric methods."] |
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| Fetal Monitoring | Monitor maternal renal function before administration; assess for allergic reactions. No specific fetal monitoring required, but consider neonatal renal function if contrast was given in third trimester. |
| Fertility Effects | No known adverse effects on fertility in humans; animal studies showed no impairment of fertility. |