References: 1. Kurt M, et al. J. Am. Coll. Cardiol. 2009;53:802-810. 2. LUMINITY® [Summary of Product Characteristics], Lantheus EU Limited. 3. Kitzman DW, et al. Am J Cardiol. 2000;86:669-674. 4. Sboros V, et al. Ultrasound in Med. & Bio. 2001; 27:1367-1377. 5. Sonne C, et al. J Am Soc Echocardiogr. 2003;16:1178-85. 6. Becher H, et al. Handbook of Contrast Echocardiography: Left Ventricular Function and Myocardial Perfusion.Heidelberg, NY: Springer-Verlag; 2002:2-44. 7. Data on file, Lantheus Medical Imaging, Inc.
Name of the medicinal product: Luminity® 150 microlitres/ml gas and solvent for dispersion for injection/infusion.
Active Ingredient: Perflutren. Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres. The approximate amount of perflutren gas in each ml is 150 microlitres (μl).
Therapeutic indications: Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast echocardiography was suboptimal 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.
Posology and method of administration Bolus intravenous injection using non-linear contrast imaging technique at rest and stress: The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. The total dose of perflutren should not exceed 1.6 ml. Bolus intravenous injection using fundamental imaging technique at rest: The recommended dose is 10 microlitre dispersion/kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest: The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Contraindications Hypersensitivity to the active substance or to any of the excipients (refer to SmPC)
Special warnings and precautions for use 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. Extreme caution should be used when considering the administration of Luminity to patients with unstable cardiopulmonary status. 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 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.
Patients with Pulmonary disease: Caution should be exercised in patients with clinically significant pulmonary disease.
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. 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.
Fertility, pregnancy and lactation: Caution should be exercised when prescribing to pregnant or breast-feeding women.
Undesirable effects: The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%). Serious adverse events include: Allergic type reactions, anaphylaxis, anaphylactic shock and anaphylactoid type reactions, seizures, cardiac arrest, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contractions), asystole, atrial fibrillation, cardiac ischaemia, supraventricular tachycardia, supraventricular arrhythmia, dyspnoea, respiratory distress and rash. Prescribers should consult the Summary of Product Characteristics in relation to other adverse reactions.
Marketing Authorisation Holder: Lantheus EU Limited
Marketing Authorisation Number(s): EU/1/06/361/001 – 002
Legal Category: Prescription Only Medicine – POM
Date: November 2019
Please see Summary of Product Characteristics
Available from your local representative and at https://www.ema.europa.eu/en/medicines/human/EPAR/luminity