What is OptiMARK?
OptiMARK is a solution for injection containing the active substance gadoversetamide. It is available in a pre-filled syringe and in a vial (500 micromoles per milliliter)
What is OptiMARK used for?
OptiMARK is intended for diagnostic use. it is indicated in patients undergoing magnetic resonance imaging (MRI), a special type of scan that reproduces images of internal organs. OptiMARK is used to obtain sharper diagnostic images in patients with known or suspected abnormalities of the brain, spine or liver.
The medicine can only be obtained with a prescription.
How is OptiMARK used?
OptiMARK should only be administered by a doctor experienced in the clinical practice of MRI. The medicine should be administered by intravenous injection (into a vein) of 100 micromoles per kilogram of body weight. OptiMARK allows you to scan for an hour, although the best time to perform the exam after the injection depends on the location and type of anomaly to be examined. For the examination of some brain abnormalities, it may be necessary to increase the OptiMARK dose or to give a second dose. The use of OptiMARK is not recommended in children under the age of two, because there is no information on the safety and efficacy of the product for this group of patients.
How does OptiMARK work?
The active substance in OptiMARK, gadoversetamide, contains gadolinium, a metal of so-called "rare earths". Gadolinium is used as a "contrast agent" to obtain better images with the
MRI scan. MRI is an imaging technique that uses the tiny magnetic fields produced by water molecules in the body. Gadolinium interacts with water molecules after administration. As a result of this interaction, water molecules transmit a stronger signal, which allows for a sharper image. In OptiMARK, gadolinium is linked to another chemical to form a "chelate" (a type of chemical compound), to prevent the metal from dispersing in the body, but rather remains "captured" in the chelate until it is expelled from the body with urine.
How has OptiMARK been studied?
The effects of OptiMARK were first tested in experimental models before being studied in humans. OptiMARK has been studied in four main studies involving a total of 804 adult patients with known or suspected abnormalities in the brain or spine (two studies conducted on 401 patients) or in the liver (two studies involving 403 patients). In all the studies, the efficacy of OptiMARK was compared to that of gadopentetate dimeglumine (another gadolinium-containing contrast agent). The main indicator of effectiveness was the difference in the ability to visualize anomalies in MRI scans with and without the contrast agent. The sharpness of each scan was evaluated by giving a score based on a four-point scale. In order to guarantee the most accurate results possible, the images were analyzed by three radiologists who did not know which contrast agent had been administered to the patient.
What benefit has OptiMARK shown during the studies?
In all studies, OptiMARK was as effective as the contrast agent in improving the ability to visualize anomalies in the scans. Both drugs produced similar improvements in the score given to the images. Considering together the two studies conducted on abnormalities of the brain and spine, the scans performed after OptiMARK administration recorded an average score increase of 0.63 (starting from a reference score of 1.58 points without OptiMARK). Very similar is the increase observed with the comparative contrast agent (0.66 points) starting from a reference score of 1.60 points. In studies conducted on liver abnormalities, both drugs improved the score (0.38 points on average) starting from a reference score of 1.82 points.
What is the risk associated with OptiMARK?
The most common side effects with OptiMARK (seen in between 1 and 10 patients in 100) are dizziness, headache, dysgeusia (altered taste sensitivity) and sensation of heat. For the full list of all side effects reported with OptiMARK, see the Package Leaflet.
OptiMARK should not be used in people who may be hypersensitive (allergic) to gadoversetamide or other ingredients of the medicine or to other drugs containing gadolinium. The medicine should not be given to patients suffering from severe kidney problems or who have suffered or are about to undergo a liver transplant, due to the risk of a condition called "nephrogenic systemic fibrosis" (NFS), a disease that causes thickening. of the skin and connective tissues.
Why has OptiMARK been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that OptiMARK's benefits are greater than its risks for the generation of magnetic resonance imaging (MRI) of the central nervous system and liver and has therefore recommended the issue of authorization marketing of the product.
More information on OptiMARK:
On 23 July 2007, the European Commission granted a marketing authorization valid for the entire European Union to OptiMARK to Tyco Healthcare Deutschland GmbH.
The full EPAR for OptiMARK can be found here.
Last update of this summary: 06-2007.
