What is Vasovist?
Vasovist is a solution for injection containing the active substance gadofosveset trisodium.
What is Vasovist used for?
Vasovist is intended for diagnostic use. It is used in patients undergoing magnetic resonance angiography (MRA), a diagnostic method in which images of blood flow into the body are acquired by means of a special scan called magnetic resonance imaging (MRI). Vasovist is used to obtain a clearer scan in patients with suspected or ascertained problems affecting the blood vessels of the abdomen (belly) or limbs.
The medicine can only be obtained with a prescription.
How is Vasovist used?
Vasovist should only be administered by physicians with experience in the field of diagnostic imaging.
Vasovist is injected with a dose of 0.12 ml per kilogram of body weight as an injection into a vein over a period of about 30 seconds. Visualization may begin immediately after injection and may last up to an hour after Vasovist administration.
How does Vasovist work?
The active substance in Vasovist, gadofosveset trisodium, contains gadolinium, a metal of so-called "rare earths". Gadolinium is used as a "contrast intensifier" to obtain better images with MRI scanners. MRI is a diagnostic imaging technique that exploits the tiny magnetic fields produced by water molecules in the body. After injection, gadolinium interacts with water molecules. As a result of this interaction, water molecules transmit a stronger signal, which allows for a sharper image. In Vasovist, gadolinium is linked to another chemical to ensure that the metal is not released into the body as well as being prepared in such a way that it binds blood to proteins. This means that the gadolinium remains in the blood long enough to get a good scan.
How has Vasovist been studied?
Vasovist has been studied in four studies involving 693 patients. Patients were scanned for suspected problems with blood vessels supplying lower limbs, kidneys or feet. All patients were first subjected to a scan using the standard X-ray method (angiography), then to an MRI scan with or without Vasovist used as a contrast intensifier. The measure of effectiveness was based on improving the detection of stenoses (narrowing of blood vessels) which reduced the width of the vessels by 50% or more.
What benefit has Vasovist shown during the studies?
The use of Vasovist to intensify the MRA has improved the diagnostic precision of the scan compared to the scan without contrast intensifiers. The sensitivity of the scan has improved between 6% and 42%. This means that with Vasovist a percentage between 6% and 42% more stenosis was found compared to the non-use of Vasovist. Vasovist also improved the accuracy and specificity of the diagnosis.
What is the risk associated with Vasovist?
The most common side effects with Vasovist (seen in more than 1 patient in 100) are headache, paraesthesia (tingling and tingling), dysgeusia (taste disturbances), burning sensation, vasodilation (dilation of blood vessels), nausea (feeling of malaise), itching and feeling of cold. For the full list of all side effects reported with Vasovist, see the Package Leaflet.
Vasovist should not be used in people who may be hypersensitive (allergic) to gadofosveset trisodium or any of the other ingredients.
Why has Vasovist been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vasovist's benefits outweigh its risks in intensifying the contrast of MRA for visualization of abdominal vessels or limbs in patients with established or suspected vascular disease. The committee recommended that Vasovist be given marketing authorization.
More information on Vasovist:
On 03 October 2005 the European Commission issued a marketing authorization for Vasovist, valid throughout the European Union. The MAH is TMC Pharma Services Ltd.
For the full EPAR for Vasovist, click here .
Last update of this summary: 06-2009.
