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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/502204/2015

EMEA/H/C/000303

EPAR summary for the public

SonoVue

sulphur hexafluoride

This is a summary of the European public assessment report (EPAR) for SonoVue. 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 SonoVue.

What is SonoVue?

SonoVue is a medicine that contains the active substance sulphur hexafluoride (a gas). It is available as a kit including one vial of gas and powder and one pre-filled syringe containing 5 ml of solvent.

When made up into a solution, SonoVue contains sulphur hexafluoride gas as 'microbubbles' in suspension in a liquid.

What is SonoVue used for?

SonoVue is for diagnostic use only. It is a contrast agent (it helps make internal body structures visible during imaging tests). SonoVue is used in tests that measure how ultrasound travels within the body because it improves the ability of the blood to create an echo. It is only used when the results of the test without a contrast agent are inconclusive. SonoVue is used in:

•    echocardiography (a diagnostic test where an image of the heart is obtained). It is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, in patients with suspected or confirmed coronary artery disease.

•    Doppler (a diagnostic test that measures the speed of blood flow). SonoVue can be used in Doppler tests for large blood vessels, such as those in the head, those leading to the head or the main vein to the liver, or for smaller blood vessels such as those in lesions (areas of disease) in the breast or liver.

The medicine can only be obtained with a prescription.

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How is SonoVue used?

SonoVue should only be used by doctors who have experience in diagnostic ultrasound imaging. It is injected intravenously (into a vein) before the test is carried out, as a 2 or 2.4 ml dose depending on which test is being carried out. The dose can be repeated.

How does SonoVue work?

The active substance in SonoVue, sulphur hexafluoride, is a gas that is not soluble in the blood. When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles. After injection, the microbubbles travel in the blood, where they reflect ultrasound waves more than the surrounding tissues. This helps to enhance the results of tests that rely on measuring ultrasound, such as echocardiography and Doppler tests. The gas is removed naturally from the body through the lungs.

How has SonoVue been studied?

SonoVue has been studied in a total of 895 patients in six main studies. These included three studies of echocardiography and three studies of Doppler.

The echocardiography studies involved a total of 317 patients, and compared SonoVue with another contrast agent and placebo (a dummy treatment).

The Doppler studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels. In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared with the 'gold standard', such as angiography (X-rays of blood vessels). The main measure of effectiveness was how clear the images obtained in the test were.

What benefit has SonoVue shown during the studies?

In the echocardiography studies, SonoVue was more effective than the comparator and than placebo in improving the clarity of the image obtained of the left ventricle and left ventricle border.

In the Doppler studies, using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys). For the smaller vessels, SonoVue led to better quality scans when looking at the blood flow in breast and liver lesions. However, this was not observed for lesions in the pancreas, kidney, ovary or prostate gland.

What is the risk associated with SonoVue?

The most common side effects with SonoVue (seen in between 1 in 100 and 1 in 1,000 patients) are headache, paraesthesia (unusual sensations like pins and needles), dizziness, dysgeusia (taste disturbances), flushing (reddening of the skin), pharyngitis (sore throat), nausea (feeling sick), abdominal pain, pruritus (itching), rash, back pain, chest discomfort, reactions at the injection site, feeling hot and raised blood sugar levels. For the full list of all side effects reported with SonoVue, see the package leaflet.

SonoVue must not be used in patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs).

SonoVue

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SonoVue must also not be used together with the medicine dobutamine (used for heart failure) in patients for whom dobutamine is not suitable. For the full list of restrictions, see the package leaflet.

Why has SonoVue been approved?

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

What measures are being taken to ensure the safe and effective use of SonoVue?

A risk management plan has been developed to ensure that SonoVue is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for SonoVue, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about SonoVue

The European Commission granted a marketing authorisation valid throughout the European Union for SonoVue on 26 March 2001.

The full EPAR for SonoVue can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with SonoVue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2015.

SonoVue

EMA/502204/2015