PLEASE NOTE: THE USE OF THIS MEDICINAL PRODUCT IS CURRENTLY SUSPENDED IN THE EUROPEAN UNION
What is Luminity?
Luminity is a solution for injection or infusion (drip into a vein) containing microspheres (tiny bubbles) of perflutren gas as the active ingredient.
What is Luminity used for?
Luminity is intended for diagnostic use only. It is a contrast agent (a medicine used to make the internal structures of the body visible in diagnostic imaging tests).
Luminity is used in adults to obtain a clearer image of the cardiac cavities, in particular of the left ventricle, during echocardiography (diagnostic examination in which the image of the heart is obtained by ultrasound). Luminity is used in patients with coronary heart disease (obstruction of the blood vessels supplying the heart muscle) suspicious or confirmed, if the image obtained by echocardiography without contrast medium is not optimal.
The medicine can only be obtained with a prescription.
How is Luminity used?
Luminity should only be administered by doctors experienced in the conduct and interpretation of images obtained with contrast echocardiography, in hospitals or clinics where adequate resuscitation equipment is available in case of heart or lung problems or allergic reactions.
Before use, Luminity must be activated by shaking it with a mechanical device called Vialmix, provided to doctors for the preparation of the medicine. This ensures that the medicine is stirred correctly and for a sufficiently long period of time in order to obtain a "dispersion" of the gaseous perflutren microspheres of the right consistency to ensure good image quality. The medicine is then administered into a vein with a "bolus" injection (all at once) or as an infusion, after dilution. The mode of administration of Luminity and the relative doses depend on the technique used for echocardiography.
For complete information, see the summary of product characteristics ( also included with the EPAR ).
How does Luminity work?
Before activation, Luminity contains a gas, perflutren, and a solution of fatty substances called phospholipids. After activation, the medicinal product contains microspheres of perflutren gas in a fatty layer of phospholipids. In echocardiography, perflutren microspheres are used as a contrast agent because, when ultrasounds are used, they generate very different echoes depending on the surrounding tissues. After the injection, Luminity flows in the veins up to the heart. In the course of echocardiography, this contributes to obtaining a better contrast between the area in which the gas bubbles are present (such as the cardiac cavities) and the surrounding tissue. The gas is then expelled through the lungs.
How has Luminity been studied?
Five main studies on the effectiveness of Luminity were conducted on a total of 401 patients. Three studies examined the effectiveness of the medicine in improving the image of the left ventricle, compared to the echocardiographic image before and after the administration of Luminity. In two of these studies, Luminity was compared with a placebo (a dummy treatment). The last two studies were carried out first of all to examine the effectiveness of Luminity in improving the accuracy of the ejection fraction measurement (the percentage of the volume of blood pumped from the heart with each beat). These studies also examined the improvement of the image of the left ventricle.
What benefit has Luminity shown during the studies?
the effectiveness of Luminity in improving the image of the left ventricle was revealed and was more effective in studies in which Luminity was compared with placebo. Since all five initial studies were performed with a technique known as "fundamental" ultrasound imaging, the company also presented the results of some studies that reveal that the results obtained with fundamental imaging can also be obtained with imaging known as "harmonics" and "non-linear".
What is the risk associated with Luminity?
The most common side effects (seen in between 1 and 10 patients in 100) are headache and redness of the skin. Patients may also develop a severe allergic reaction to Luminity and should be closely monitored. For the full list of all side effects reported with Luminity, see the Package Leaflet.
Luminity should not be used in people who may be hypersensitive (allergic) to perflutren or any of the other components.
Why has Luminity been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Luminity's benefits are greater than its risks for use as an ultrasound contrast agent in echocardiography and recommended that it be given marketing authorization. .
More information about Luminity:
On 20 September 2006, the European Commission issued a marketing authorization for Luminity, valid throughout the European Union. Marketing Authorization Holder is Lantheus MI UK Ltd.
The full EPAR for Luminity can be found here.
Last update of this summary: 08-2009.
