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Primovist®

Primovist® is a liver-specific contrast agent for magnetic resonance imaging (MRI) Liver. Specific. Confidence.

Primovist® is a 0.25mmol/ml hepatocyte specific MRI contrast agent. It has combined properties of an extracellular agent and a liver specific agent. The active ingredient of Primovist® is disodium gadoxtate. It is a gadolinium containing contrast agent in which the Gd3+ ion is firmly bound in a complex. Primovist® is first distributed in the extracellular space of the body, allowing traditional T1-weighted dynamic vascular images to be acquired. The vascular phase is followed by a gradual transition of the agent into functioning hepatocytes through transporters within the cell membranes (equilibrium phase). The intracellular enhancement reaches a plateau about 10-20 minutes after Primovist® injection. This accumulation of Primovist® in the liver cells allows an additional delayed imaging phase to take place with an extended imaging window. During this phase, healthy liver parenchyma is enhanced in T1-weighted images.

Primovist®

Application

Primovist® is provided in ready-to-use 10 mL prefilled glass syringes.
 

How is Primovist® administered?

Primovist® is administered intravenously preferably with the use of a MR power injector.
 

Indications8

This medicinal product is for diagnostic use only. Primovist® is indicated for use in adults for the enhancement of magnetic resonance imaging (MRI) of focal liver lesions.

Primovist® First Line Imaging

High Accuracy in Liver Lesion Detection1 and recommended by Oncologic guidelines2,3,4,7,8

International diagnostic guidelines recognise Primovist® as one of the first-line imaging modality options for diagnosis of Hepatocellular Carcinoma (HCC)

  • Asian Pacific Association for the Study of the Liver (APASL) *,2
  • Japan Society of Hepatology, consensus statement *,3
  • Korean Liver Cancer Study Group *,4
  • European Association of the Study of the Liver (EASL) 7
  • American Association for the Study of Liver Diseases Group (AASLD / LI-RADS) 8

The current European Society for Medical Oncology (ESMO) guideline for metastatic Colorectal Cancer (CRC) recommends Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) for detection of liver lesions and points out that Primovist® is more sensitive in lesions < 10 mm.5

Primovist_APASL Diagnostic Algorithm image

Primovist® & CRCLM1

Primovist® may provide a higher detection rate compared to CT or multi-purpose Gadolinium based contrast agent (GBCA)1

  • Primovist® may increase confidence in the therapeutic plan.1
  • Primovist® helps provide a confident diagnosis and surgical plan when used as the primary imaging modality and further imaging is not required.1
product value

Figure:5 Adapted from the data in the VALUE study

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References

1. Zech CJ, et al. Br J Surg. 2014;101(6):613–21.

2.Omata M et al. Hepatol Int. 2017;11:317–370

3.Kudo M et al. Liver Cancerl. 2014;3:458– 68

4.Korean Liver Cancer Association (KLCA) and National Cancer Center (NCC).Korean J Radiol. 2019;20(7):1042–1113.

5.Van Cutsem E, et al. annals of Oncology 2016;27:1386-1422

6.Halavaara J et al. Comput Assist Tomogr. 2006;30:345–54.

7.European Association for the Study of the Liver (EASL).J Hepatol. 2018;69(1):182 – 236

8.Primovist® PI February 2020

Minimum Product Information

PBS Information: This product is not listed on the PBS

PRIMOVIST® [disodium gadoxetate 0.25 mmol/mL]
Please review the full Product Information before prescribing. Approved PI available at
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2009-PI-01225- 3&d=201909251016933 or upon request from Bayer Australia Ltd,
ABN 22 000 138 714, 875 Pacific Highway, Pymble NSW 2073, phone 1800 008 757.

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