Optimark

gadoversetamide

This is a summary of the European public assessment report (EPAR) for Optimark. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Optimark.

What is Optimark?

Optimark is a solution for injection that contains the active substance gadoversetamide. It is available in prefilled syringes and in vials.

What is Optimark used for?

Optimark is for diagnostic use. It is used in patients who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken. Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.

The medicine can only be obtained with a prescription.

How is Optimark used?

Optimark should only be given by a doctor who has experience in using MRI. It is given as an injection into a vein.

Optimark allows images to be taken for up to an hour after it has been injected, although the best time to take a scan depends on the location and type of abnormality that is being examined. When looking at certain abnormalities in the brain, Optimark may need to be used at a higher dose, or the dose may need to be repeated.

Patients who have moderate problems with their kidneys should only receive Optimark if their doctor has carefully balanced the benefits and risks of using it. These patients should receive no more than one dose of Optimark during each MRI scan, and there should be a gap of at least a week between each Optimark injection. Optimark must not be used in patients with severe kidney problems.

How does Optimark work?

The active substance in Optimark, gadoversetamide, contains gadolinium, a ‘rare-earth’ metal element. Gadolinium is used as a ‘contrast agent’ to help obtain better images with MRI scans. MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body. Once injected, gadolinium interacts with the water molecules. As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture. In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped’ until it is eliminated from the body in the urine.

How has Optimark been studied?

Optimark has been studied in four main studies involving a total of 804 adults who had or were thought to have abnormalities in the brain or spine (two studies in 401 patients) or in the liver (two studies in 403 patients). In all of the studies, the effects of Optimark were compared with those of gadopentetate dimeglumine (another contrast agent containing gadolinium). The main measure of effectiveness was the difference in the ability to see the abnormalities on MRI scans taken with and without the contrast agent. Each scan’s clarity was scored on a four-point scale. The scans were analysed by three radiologists (doctors specialised in carrying out and interpreting scans of the body). The radiologists did not know what treatment the patient had received beforehand, to make sure that the studies’ findings were as accurate as possible.

What benefit has Optimark shown during the studies?

In all of the studies, Optimark was as effective as the comparator contrast agent in improving the ability to see abnormalities on the scans.

In the two studies of brain and spine abnormalities taken together, scans taken with Optimark had a score increase of 0.63 points on average from a ‘baseline’ of 1.58 points without Optimark. This compared with an increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.

In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline 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, headaches, dysgeusia (taste disturbances) and feeling hot. 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, any of the other ingredients or other medicines containing gadolinium. It must not be used in patients who have severe problems with their kidneys, in patients who have had or are about to have a liver transplant, or in babies aged less than four weeks, due to a risk of a condition called nephrogenic systemic fibrosis (NSF). NSF causes thickening of the skin and connective tissues.

Why has Optimark been approved?

The CHMP decided that Optimark’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Optimark

The European Commission granted a marketing authorisation valid throughout the European Union for Optimark to Covidien Deutschland GmbH on 23 July 2007. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Optimark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 03/05/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

20/04/2012  Optimark -EMEA/H/C/000745 -II/0010

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Contrast media

Therapeutic indication

This medicinal product is for diagnostic use only.

Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents