Luminity

perflutren

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Luminity?

Luminity is a solution for injection or infusion (drip into a vein) that contains microspheres (tiny bubbles) of perflutren gas as the active substance.

What is Luminity used for?

Luminity is for diagnostic use only. It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests).

Luminity is used in adults to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound). Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained with non-contrast echocardiography is not optimal.

The medicine can only be obtained with a prescription.

How is Luminity used?

Luminity should only be given by doctors trained in performing and reading images obtained with contrast echocardiography, in hospitals or clinics where appropriate resuscitation equipment is available in case of heart or lung problems or allergic reactions.

Before use, Luminity must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine. This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion’ of microspheres of perflutren gas of the right size to get a good quality image. This is then given into a vein either as a ‘bolus’ injection (given all at once) or as an infusion after being diluted. The way Luminity is given and the dose depend on the technique used for the echocardiography.

For full details, see the Summary of Product Characteristics (also part of the EPAR).

How does Luminity work?

Before activation, Luminity contains a gas, perflutren, and a solution of fatty substances called phospholipids. After activation, the medicine contains microspheres of perflutren gas in a fatty layer of phospholipids. Perflutren microspheres are used as a contrast agent in echocardiography because, when using ultrasound, they generate echoes very differently from the surrounding tissues. When Luminity is injected, it travels in the veins to the heart. This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue during the echocardiography. The gas is then cleared through the lungs.

How has Luminity been studied?

There have been five main studies of Luminity, involving a total of 401 patients. Three studies looked at its ability to enhance the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity. In two of these studies, Luminity was compared with placebo (a dummy treatment). The last two studies were set up primarily to look at the ability of Luminity to improve the accuracy of the measurement of the ejection fraction (the percentage of the blood volume that is pumped out of the heart in one beat). These studies also looked at left ventricle image enhancement.

What benefit has Luminity shown during the studies?

Luminity was effective in enhancing the image of the left ventricle, and it was more effective than placebo in the studies where Luminity and placebo were compared. As all five original studies were carried out with a technique known as ‘fundamental’ ultrasound imaging, the company also presented the results of some studies to show that the results seen using fundamental imaging could also be obtained when using the imaging techniques known as ‘harmonic’ and ‘non-linear’.

What is the risk associated with Luminity?

The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin). Patients can also develop a severe allergic reaction to Luminity, and must 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 ingredients.

Why has Luminity been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Luminity’s benefits are greater than its risks for use as an ultrasound contrast-enhancing agent in echocardiography. The Committee recommended that Luminity be given marketing authorisation.

Other information about Luminity:

The European Commission granted a marketing authorisation valid throughout the European Union for Luminity on 20 September 2006. The marketing authorisation holder is Lantheus MI UK Ltd.

This EPAR was last updated on 10/11/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

13/09/2011  Luminity -EMEA/H/C/000654 -R/0011

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.

Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents