LUMINITY Gas and solvent for dispersion for injection/infusion Ref.[27908] Active ingredients: Perflutren

This product must only be administered intravenously.

Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.

Patients with unstable cardiopulmonary status

During contrast-enhanced echocardiography, serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes of Luminity administration in patients including those with severe cardiac and pulmonary diseases (see section 4.8). Extreme caution should be used when considering the administration of Luminity to patients with unstable cardiopulmonary status, for example: unstable angina, acute myocardial infarction, severe ventricular arrhythmias, severe heart failure (NYHA IV) or respiratory failure. Luminity should only be administered to such patients after careful risk/benefit assessment.

Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management.

Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration. For such patients monitoring should include vital sign measurements, electrocardiography, and, if clinically appropriate, cutaneous oxygen saturation. Resuscitation equipment and trained personnel must always be readily available.

Patients with adult respiratory distress syndrome, endocarditis, prosthetic heart valves, systemic inflammation, sepsis, hyperactive coagulation and/or recurrent thromboembolism

Luminity should be used only after careful consideration and such use should be monitored closely during administration in patients with adult respiratory distress syndrome, endocarditis, a heart with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation and/or recurrent thromboembolism.

Hypersensitivity reactions

Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity, including in patients with prior allergic reaction(s) to polyethylene glycol (see Section 6.1). Patients should be closely monitored and administration should be under the direction of a physician experienced in the management of hypersensitivity reactions including severe allergic reactions, which might require resuscitation. Emergency equipment and personnel trained in its use must be readily available.

Pulmonary disease

Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have been performed in these patients.

Patients with Cardiac Shunts

The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied. In these patients, phospholipid encapsulated microspheres can bypass the lung and directly enter the arterial circulation. Caution must be exercised when considering the administration of Luminity to these patients.

Patients on mechanical ventilation

The safety of microspheres in patients on mechanical ventilation has not been established. Caution should be exercised when considering the administration of Luminity to these patients.

Administration and mechanical activation procedure

Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial injection).

If Luminity is administered directly to the patient without undergoing the mechanical activation procedure using the Vialmix (see section 6.6), the product will not produce its intended effect.

Sodium Content

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree’.

No interaction studies have been performed and no other forms of interaction have been identified.

Pregnancy

For perflutren, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women.

Breast-feeding

It is not known whether Luminity is excreted in human breast milk. Therefore, caution should be exercised when Luminity is administered to breast-feeding women.

Fertility

Animal studies do not indicate direct or indirect harmful effects on fertility.

As Luminity has no pharmacologic effect, and on the basis of its pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of this product on the ability to drive or use machines.

Summary of the safety profile

The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes. The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).

Tabulated list of adverse reactions

Adverse reactions were reported with the following frequencies (Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000; Very rare <1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

This medicinal product must not be mixed with other medicinal products except those mentioned in
section 6.6.