What is SonoVue?
SonoVue is a medicine containing the active substance sulfur hexafluoride (a gas). It is available in a kit that includes a vial containing gas and powder and a pre-filled syringe containing 5 ml of solvent. When reconstituted in solution, 1 ml of SonoVue contains 8 microliters of sulfur hexafluoride, in the form of "microbubbles" that are created in the liquid suspension.
What is SonoVue used for?
SonoVue is intended for diagnostic use only. It is a contrast agent (ie a substance that allows the visualization of internal structures in diagnostic imaging tests). SonoVue is used in diagnostic tests that use ultrasounds, because it accentuates the echogenicity of the blood (the ability of the blood to produce an echo). The medicine is only indicated in patients for whom the contrast-free test is not accurate enough. SonoVue is suitable for:
- echocardiography (ultrasound of the heart). The medicine is used to obtain a clearer view of the cardiac cavities, especially of the left ventricle, in patients with suspected or established coronary artery disease;
- the Doppler exam (a diagnostic test that measures the speed of blood flow). SonoVue can be used in the Doppler examination of large vessels, such as those supplying the brain area, those flowing to the head or the main vein that carries blood to the liver, or microcirculation (smaller blood vessels) such as those present in the lesions of the breast or liver.
The medicine can only be obtained with a prescription.
How is SonoVue used?
SonoVue should only be administered by physicians experienced in ultrasound diagnostic methods. It is administered intravenously (in a vein) before a diagnostic test, at a dose of 2 or 2.4 ml, depending on the examination to be performed. A second injection is possible. SonoVue has not been studied in people under the age of 18, so its use in these patients is not recommended.
How does SonoVue work?
The active ingredient of SonoVue, sulfur hexafluoride, is a gas that does not dissolve in the blood. When SonoVue is suspended, the gas remains trapped in tiny bubbles called "microbubbles". After the injection, microbubbles circulate in the blood, where they reflect the signal
ultrasonographic more than the other body tissues. This helps improve the results of ultrasound exams, such as echocardiography and Doppler diagnostics. The gas is eliminated from the body through the exhaled air.
What studies have been carried out on SonoVue?
SonoVue has been studied in six main studies out of a total of 895 patients. Of these, three studies involved echocardiography and three Doppler exams.
The studies conducted on echocardiography involved a total of 317 patients and compared the effects of SonoVue with those of another contrast medium and placebo (a dummy treatment).
Doppler studies involved 361 patients with abnormalities of the large blood vessels and 217 patients with abnormalities of the smaller vessels. In these studies, SonoVue was not compared with other medicines, but the results of examinations performed with SonoVue were compared with better diagnostics, such as angiography (a blood vessel X-ray). The main measure of effectiveness was the sharpness of the images obtained in the exams.
What benefits has SonoVue shown during the studies?
In echocardiography studies, SonoVue was more effective than the comparator and placebo in improving the sharpness of the left ventricle and endocardial edge of the left ventricle.
In Doppler studies, the use of SonoVue to measure blood flow in large blood vessels has improved the diagnostic accuracy in examinations of cerebral arteries, carotids (neck artery) and portal vein (entering the liver), but not of the renal arteries. For smaller vessels, SonoVue has improved the image quality of blood flow in breast and liver lesions. However, no better quality was observed for injuries to the pancreas, kidneys, ovaries or prostate gland.
What is the risk associated with SonoVue?
The most common side effects reported with SonoVue (seen in a number of patients between 1 and 10 out of 100) are headache, nausea, reactions at the injection site including hematoma (shedding of blood in a tissue), sensation of burning and paresthesia (abnormal tingling and tingling sensation). For the full list of all side effects reported with SonoVue, see the Package Leaflet.
SonoVue should not be used in people who may be hypersensitive (allergic) to sulfur hexafluoride or any of the other ingredients. SonoVue should not be administered to:
- patients with acute coronary syndrome (coronary artery symptoms) of recent evolution or with unstable cardiac ischemia (marked decrease in normal blood supply to the heart);
- patients with known right-to-left shunts (abnormal blood movements within the heart), patients with severe pulmonary hypertension (high blood pressure in the pulmonary artery, the vessel that connects the heart to the lungs), uncontrolled hypertension and affected patients from adult respiratory distress syndrome (severe accumulation of fluid in both lungs);
- pregnant or nursing women.
Why has SonoVue been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that SonoVue's benefits outweigh its risks in increasing the echogenicity (ultrasonic contrast) of blood in echocardiography in patients with suspected or established cardiovascular disease, to dull the cardiac chambers and improve the definition of the left ventricular endocardial border, as well as in the Doppler diagnosis of large vessels (cerebral arteries, extracranial carotids or peripheral arteries, and portal vein) or of microcirculation (lesions of the liver and breast). The committee therefore recommended that SonoVue be given marketing authorization.
Other information about SonoVue:
On March 26, 2001, the European Commission issued a marketing authorization for SonoVue to Bracco International BV, valid throughout the European Union. The marketing authorization was renewed on 26 March 2006.
The full EPAR for SonoVue can be found here.
Last update of this summary: 09-2007
