MultiHance® is a gadolinium based MRI contrast agent that has twice the relaxivity of conventional extracellular fluid (ECF) contrast agents, providing a marked increase in SNR to better visualize smaller lesions and improve the delineation of larger lesions.
The increase in relaxivity of MultiHance® is due to its weak, reversible interaction with plasma proteins. MultiHance® is eliminated through the kidney and, to a lesser extent, through the liver, making it the first product which is both an ECF and a hepatospecific contrast agent at the same time.
Prospective, randomized, double-blind, crossover studies have shown that the higher relaxivity of MultiHance® translates into a significantly better contrast enhancement and lesion conspicuity compared to gadopentetate dimeglumine (as well as to gadobutrol, gadoterate and gadodiamide) at equivalent doses of gadolinium in MRI of the central nervous system, or into similar contrast enhancement if a half dose of MultiHance® is compared to a full dose of lower relaxivity contrast agents in MR angiography; therefore, it is less likely that high doses of MultiHance® are used in clinical practice.
In adult patients, MultiHance® is indicated in Europe, and in several countries in Asia and Latin America, for MRI exams of the CNS (brain and spine) and for MRI of the liver, as well as for MRA (Magnetic Resonance Angiography), where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease in adult patients with suspected or known disease of the abdominal or peripheral arteries.
In the US, MultiHance® is indicated for MRI of the CNS, and it has recently received approval of the FDA for contrast-enhanced MR Angiography (MRA). In this indication, MultiHance® can be used to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
In Europe and in North America, MultiHance® is also indicated for MRI of the CNS in paediatric patients above 2 years of age.
The recommended dose of MultiHance® in MRI of the CNS, MRA, and MRI of the breast is 0.1 mmol/kg body weight, equal to 0.2 mL/kg of the 0.5 M solution; in MRI of the liver, the recommended dose is 0.05 mmol/kg body weight, equal to 0.1 mL/kg of the 0.5M solution. MultiHance® is also available in pre-filled syringes (PFS) of 10, 15 and 20 mL.
Data from a large (N = 151), crossover, randomized, double blind, intraindividual comparison study (Study MH-109) demonstrate that the dose of 0.1 mmol/kg (0.2 ml/kg) of MultiHance® provides significantly (p < 0.001) more diagnostic information than the same dose of gadopentetate in MRI of the central nervous system (CNS 3), in terms of:
- Improved delineation of brain and spine lesion borders
- Improved definition of extent of CNS intra-axial and extra-axial tumours
- Improved visualization of internal morphology of CNS tumours
- Improved enhancement between normal parenchyma and lesions.
The quantitative assessments performed in this study showed that MultiHance® provides significantly greater increase of signal intensity in CNS lesions and significantly greater lesion-to-brain contrast enhancement compared to gadopentetate. Similar results in favour of MultiHance® have also been shown in 2 other large intraindividual crossover comparative studies in MRI of the CNS, vs gadobutrol (the MERIT study) and vs gadodiamide (the ENHANCE study).
MultiHance® shows high clinical utility in MRI of the liver as well, where the high relaxivity combined with a dual route of elimination through the kidney and the liver make MultiHance® an efficient agent in liver imaging, even if administered at doses smaller than those employed for the conventional ECF agents.
In MR Angiography, MultiHance® significantly improves visualization, as well as the detection of significant steno-occlusive disease of the abdominal or peripheral arteries.
MultiHance® is well tolerated with a safety profile similar to that of other MRI gadolinium based contrast agents.
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Pintaske J, Martirosian P, Graf H, Erb G, Lodemann KP, Claussen CD, Schick F.Invest Radiol. 2006 Mar;41(3):213-21. Erratum in: Invest Radiol. 2006 Dec;41(12):859.
2) Gadolinium chelates with weak binding to serum proteins. A new class of high-efficiency, general purpose contrast agents for magnetic resonance imaging.
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3) Contrast-enhanced MR imaging of brain lesions: a large-scale intraindividual crossover comparison of gadobenate dimeglumine versus gadodiamide.
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4) A comparison of Gd-BOPTA and Gd-DOTA for contrast-enhanced MRI of intracranial tumours.
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Seidl Z, Vymazal J, Mechl M, Goyal M, Herman M, Colosimo C, Pasowicz M, Yeung R, Paraniak-Gieszczyk B, Yemen B, Anzalone N, Citterio A, Schneider G, Bastianello S, Ruscalleda J.AJNR Am J Neuroradiol. 2012 Jun;33(6):1050-8. doi: 10.3174/ajnr.A3033. Epub 2012 Mar 1.
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8) Prospective comparison of image quality and diagnostic accuracy of 0.5 molar gadobenate dimeglumine and 1.0 molar gadobutrol in contrast-enhanced run-off magnetic resonance angiography of the lower extremities.
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9) MultiHance® SPC
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Maravilla KR, Maldjian JA, Schmalfuss IM, Kuhn MJ, Bowen BC, Wippold FJ 2nd, Runge VM, Knopp MV, Kremer S, Wolansky LJ, Anzalone N, Essig M, Gustafsson L.Radiology. 2006 Aug;240(2):389-400. Epub 2006 Jun 26.
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Morcos SK.Br J Radiol. 2007 Feb;80(950):73-6. Epub 2007 Mar 28. No abstract available. Erratum in: Br J Radiol. 2007 Jul;80(955):586.
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|MultiHance PFS Package Insert(PDF)||10/06/2022||Download|
|MultiHance Vials Package Insert(PDF)||10/06/2022||Download|
|The strength of relaxivity in CNS imaging(PDF)||10/06/2022||Download|
|The contrast imaging specialists(PDF)||10/06/2022||Download|
|MultiHance in MRA(PDF)||10/06/2022||Download|
|Abstract: CNS study(PDF)||10/06/2022||Download|
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Impaired renal function
There have been reports of Nephrogenic Systemic Fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR<30ml/min/1.73m2). As there is a possibility that NSF may occur with MultiHance, it should be avoided in patients with acute or chronic severe renal impairment (GFR<30ml/min/1.73m2) and in patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period unless the diagnostic information is essential and cannot be obtained through other means.
The risk for the development of NSF in patients with moderate renal impairment is unknown, therefore MultiHance should be used with caution in patients with moderate renal impairment (GFR 30-59ml/min/1.73m2). All patients should be screened, in particular patients over the age of 65, for renal dysfunction by obtaining a history and/or laboratory tests. Haemodialysis shortly after MultiHance administration may be useful at removing MultiHance from the body.
There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.