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Primovist®

Primovist® is a liver-specific contrast agent for magnetic resonance imaging.

Liver. Specific. Confidence.

Primovist® significantly improves the detection and characterization of focal liver lesions and is particularly valuable in the detection of small lesions.1 Radiologists have reported a high diagnostic confidence in the diagnosis of liver disease. Primovist-MRI has been shown to significantly reduce the need for additional liver imaging to confirm diagnosis and decide on therapy.2

1 Hammerstingl R, et al. Eur Radiol. 2008;18(3):457–67.

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

Primovist

What is Primovist®?

Primovist® is a 0.25 molar hepatocyte specific MRI contrast agent. It has combined properties of an extracellular agent and a liver specific agent.
 

How does Primovist® work?

The active ingredient of Primovist® is gadoxetate disodium.

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 hepatocytes through transporters within the cell membranes (transitional 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 positively enhanced in T1-weighted images.

Application

Primovist® is available in 10 mL vials.

How is Primovist® administered?

Primovist® is administered intravenously as a fast bolus (1-2 mL/sec). Use of an injector is recommended and there is some evidence to suggest that a slower injection speed of 1 mL/sec may be beneficial, due to a reduction in imaging artifacts.

Indications

Primovist® is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted MRI.6

Image highlight

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

2 Endrikat J et al. J Magn Reson Imaging. 2015;42(3):634–43.

3 Endrikat J et al. Acta Radiol. 2016; 57(11):1326–33.

4 Hammerstingl R, et al. Eur Radiol. 2008;18(3):457 – 467

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

6 Primovist® Product Monograph. May 12, 2017

Characteristics


Primovist® is:

  • provided as a ready-to-use solution of 0.25 mmol Gd/mL.
  • for diagnostic use by intravenous administration only.
  • a stable colorless solution of low osmolality and low viscosity.
     
Physicochemical data  
Parameter Gd-EOB-DTPA

Viscosity (at 37°C)

1.19 mPa.s
Osmolality (at 37°C) 688 mOsm/kg H2O
Density (at 37°C) 1.0881 g/mL
Relaxivity r1
(at 1.5 Tesla, in plasma, 37°C)
6.9 l/(mmol-1s-1)
[Rohrer et al.]
Relaxivity r2
(at 1.5 Tesla, in plasma, 37°C)
8.7 l/(mmol-1s-1)
[Rohrer et al.]


Primovist® administration at 25 µmol/kg BW provided improved diagnostic confidence in 90% of patients in phase 2 studies.
 


Primovist® 0.25 mmol / mL, solution for injection, prefilled syringe (gadoxetate disodium). 

Composition: PRIMOVIST is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow aqueous solution containing 181.43 mg/mL (0.25 mmol/mL) of gadoxetate disodium, caloxetate trisodium, trometamol, and water for injection. Sodium hydroxide and/or hydrochloric acid are added to adjust pH. No preservative is added.

Indication: PRIMOVIST (gadoxetate disodium injection) is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

Contraindications: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

Serious Warnings and precautions: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents (GBCAs) increase the risk for Nephrogenic Systemic Fibrosis (NSF) in patients with:

  • chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 m2), or;
  • acute renal failure / acute kidney injury

In these patients, avoid use of GBCAs unless the diagnostic information is essential and not available with noncontrast-enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a GBCA, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.

Adverse Reactions: Most adverse drug reactions reported with PRIMOVIST were of mild to moderate severity, and did not require a discontinuation of the procedure. The most frequently reported adverse reactions in clinical trials were headache (0.6%; mild), nausea (0.7%; usually occurring just after injection and resolving quickly), and feeling hot (0.7%: usually occurring during injection).

For additional information, please visit the Product Monograph.

If you want to report a side effect or quality complaint, please contact your healthcare professional (e.g. physician or pharmacist) or your local health authority.
Side effects can also be reported to Bayer Inc. by clicking here.

 

 

Studies

Delayed tumour enhancement may predict...

Delayed tumour enhancement of colorectal liver metastases (CRLM) on gadoxetate-enhanced MRI is associated with survival post-hepatectomy, according...

News on Benign Liver Lesions

Differentiation between the benign liver lesion focal nodular hyperplasia (FNH) and hepatocellular adenomas (HCAs) …

MRI potentially changes liver resection planning

Prospective comparison of gadoxetic acid-enhanced liver MRI and contrast-enhanced CT for preoperative detection of...

Primovist® in the Elderly

Gadoxetate disodium shows a good safety profile in patients older than 65 years.

 

Interviews

Interview-Murakami_radike

"Radiologists should stand up for themselves"

Takamichi Murakami is Professor and Chairman of the Department of Radiology at Kinki University Faculty of Medicine in Osaka, Japan.

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