Sonovue: Uses, Side Effects and Dosage

What is SonoVue used for?

• SonoVue is a contrast agent for diagnostic use with ultrasound imaging.

How does SonoVue work?

SonoVue reflects the ultrasound beam. This provides a better echo and view of your tissues and problems in your body.

What are the ingredients in SonoVue?

Medicinal ingredients: sulfur hexafluoride

Non-medicinal ingredients:

dipalmitoylphosphatidylglycerol (DPPG.Na), distearoylphosphatidylcholine (DSPC), palmitic acid, polyethylene glycol (PEG), sodium chloride (0.9% solution for reconstitution)

SonoVue comes in the following dosage forms:

Suspension for injection, 48 μg/mL (8 μL/mL) reconstituted.

Do not use SonoVue if:

• You have right-to-left shunts (small hole or passage) of the heart;
• You have a condition where medicines or devices are needed to help maintain normal blood pressure and heart function (e.g. cardiovascular instability) and are taking dobutamine;
• You have high pulmonary artery blood pressure (high blood pressure in the blood vessels of your lungs);

Serious Warnings and Precautions

• You have uncontrolled hypertension (high blood pressure);
• You have adult respiratory distress syndrome (fluid build-up in your lungs). This causes shortness of breath;
• You have, or have ever had, an unusual or allergic reaction to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SonoVue. Talk about any health conditions or problems you may have, including if you:

• are pregnant or planning to become pregnant.

• are breast feeding or planning to breastfeed.
• have acute coronary syndrome or cardiac ischemia (reduced blood flow to your heart).
• had a heart attack (myocardial infarction).
• had any procedure on the artery supplying blood to the heart (coronary artery).
• suffer from angina (a type of chest pain), heart failure or severe heart rhythm disorders.
• have had changes in the electrical activity of your heart (electrocardiography changes).
• have a congenital heart defect (including right-to-left ventricular shunts).
• have severe increased pulmonary hypertension (high blood pressure in the blood vessels of the lung).
• have acute or severe congestive heart failure, unstable angina (blockage of the heart’s arteries), or a severe arrhythmia (irregular heartbeat).
• have acute endocarditis (inflammation of your heart’s inner lining).
• have a prosthetic valve (a surgically implanted valve).
• have an unstable neurological disease.
• have a chronic obstructive pulmonary disease (inflammation of your lungs that reduces airflow from the lungs).
• have problems with your lungs or are using a mechanical ventilator (a machine that helps you breathe).
• had recent organ transplant.
• have any personal or family history of altered heart rhythm e.g. QTc prolongation.

• have any personal or family history of altered heart rhythm e.g. proarrhythmic conditions such as:

  • recent hypopotassemia (low potassium blood levels),
  • significant bradycardia (low heartbeat),
  • acute myocardial ischemia (insufficient blood supply to the heart),
  • clinically relevant heart failure with reduced left-ventricular ejection fraction or previous history of symptomatic arrhythmias.

• are taking any medications (including non-prescription drugs) before having this procedure such as:

  • class IA antiarrhythmic agents e.g., quinidine, procainamide,
  • class III antiarrhythmic agents e.g., amiodarone, sotalol,
  • drugs that prolong the QT interval e.g., cisapride, erythromycin, some antipsychotics, tricyclic antidepressants.
• are taking beta blockers (a class of medications), including some eye drop medicines.
• have liver or kidney disease.
• have ongoing serious infection (sepsis).
• have recent thromboembolism (a blood clot blocking blood flow in the body).

had allergic reactions to products that contain the ingredient polyethylene glycol (PEG).

Other warnings you should know about:

Your procedure with SonoVue should only be performed by a doctor who is trained and has the knowledge of the process.

In rare cases, SonoVue can cause skin erythema (redness of skin), bradycardia (low heart rate), hypotension (low blood pressure) or anaphylactic shock (severe allergic reaction).

Your doctor may monitor your heart with an electrocardiogram (EGC) during your procedure with SonoVue. Your doctor may also monitor your blood pressure during your procedure with SonoVue.

Your doctor will monitor you for 30 minutes after your procedure with SonoVue.

The safety of SonoVue has not been determined in children for use in echocardiography, nor in diagnostic assessment of vessels.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SonoVue:

• No drug interaction studies have been done for SonoVue.

How to take SonoVue:

• SonoVue will be given to you by a healthcare professional in a healthcare setting.

Usual dose:

Usual adult dose is 1 mL to 2.0 mL depending on your condition, as determined by your doctor.

Overdose:

No overdosing has so far been reported.

What are possible side effects from using SonoVue?

These are not all the possible side effects you may have when taking SonoVue. If you experience any side effects not listed here, tell your healthcare professional.

SonoVue will only be administered to you by a qualified health care professional during an ultrasound examination. Report to them any side effects you experience during or after the procedure.

You will be monitored for 30 minutes after your examination.

Adult subjects

Common side effects

• Headache
• Nausea
• Injection site pain

Uncommon side effects

• Paresthesia (tingling, pins and needles sensation, burning pain, numbness, prickling)
• Vomiting

Pediatric subjects

Uncommon side effects related to the catheterization procedure (insertion of a catheter)

• Dysuria (painful urination)
• Abdominal pain
• Anxiety
• Crying during micturition (urination)
• Blood and mucous discharge
• Increased frequency of micturition (urination)
• Vomiting
• Perineal irritation
• Urinary tract infection

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Healthcare professional will store the kit before and after reconstitution at 15-25°C.

If you want more information about SonoVue:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.braccoimaging.com, or by calling 1-800-465-5820.

Last Revised: December 14, 2021