LUMINITY

Package leaflet: Information for the user

Luminity 150 microlitres/ml gas and solvent for injectable dispersion / for infusion

perflutren
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Luminity is and what it is used for
2. What you need to know before you use Luminity
3. How to use Luminity
4. Possible side effects
5. How to store Luminity
6. Further information

1. What Luminity is and what it is used for

Luminity is an ultrasound contrast agent containing tiny microspheres (bubbles) of perflutren gas as the active substance.
Luminity is for diagnostic use only. It is a contrast medium (a medicinal product that helps make internal body structures visible during imaging diagnostic tests).
Luminity is used in adults to obtain a clearer scan of the heart chambers, particularly the left ventricle, during echocardiography (a diagnostic test designed to produce an image of the heart using ultrasound). Luminity is used in patients with suspected or confirmed coronary artery disease (blockage of the blood vessels supplying the heart muscle) when the image obtained from echocardiography without contrast agent is not optimal.

2. What you need to know before using Luminity

Do not use Luminity

• if you are allergic to perflutren or to any of the excipients of Luminity (listed in section 6).

If you have previously experienced an allergic reaction to Luminity or to another ultrasound contrast agent, inform your doctor.
Warnings and precautions
Talk to your doctor before using Luminity

• if your doctor has told you that you have a cardiac shunt
• if you have severe heart or lung disorders or require mechanical respiratory support
• if you have an artificial heart valve
• if you have acute severe inflammation/sepsis
• if you have a known condition of hyperactivity of the coagulation system (blood clotting disorders) or recurrent thromboembolism (blood clots)
• if you have liver damage
• if you have kidney damage
• if you have previously had an allergic reaction to polyethylene glycol

Children and adolescents
Luminity must not be used in children and adolescents (under 18 years of age) as it has not been studied in these patient groups.
Other medicines and Luminity
Inform your doctor if you are taking, or have recently taken, any other medicines.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or breastfeeding, and consult your doctor or pharmacist before receiving Luminity.
Driving and using machines
Luminity has no effect on the ability to drive vehicles or operate machinery.
Luminity contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially sodium-free.
Luminity contains propylene glycol.
This medicine contains 103.5 mg/ml of propylene glycol, equivalent to 182.2 mg in each vial.

3. How to use Luminity

Luminity is administered before or during an ultrasound examination by healthcare professionals, such as doctors experienced in this type of procedure. They will calculate the correct dose for you.
Luminity is for intravenous use (direct injection into the vein). Before use, this medicine must be activated by shaking it with a mechanical device called Vialmix, which is supplied to physicians preparing the medicine. This ensures that the medicine is shaken correctly and for the required duration to produce microspheres of perflutrene gas of the appropriate size to obtain a high-quality image.
Luminity is then administered into a vein either as an intravenous bolus injection (all at once) or by infusion (drop by drop) after dilution with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) injection solution. In some cases, the physician may choose to use two injections to complete the ultrasound examination. The route of administration and dose of Luminity will depend on the echocardiography technique used.
If you are given more Luminity than you should have
Since this medicine is administered by a physician, overdose is unlikely. In the event this occurs, the physician will take appropriate measures.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some patients may experience allergic-type reactions, such as facial swelling. However, there is a risk that these allergic-type reactions may become severe and include anaphylactic shock (a serious, potentially fatal allergic response). Some patients may also experience seizures, which may be associated with these allergic reactions.
Cardiac or respiratory problems, including cardiac arrest, have occurred in some patients. In clinical trials, these reactions were reported rarely; regarding post-marketing reports, the frequency is unknown.

Common side effects (may affect more than 1 in 10 people)
Headache, flushing.

Uncommon side effects (may affect more than 1 in 100 people)

• Dizziness,
• taste disturbance,
• reduced blood pressure,
• breathing difficulties, throat irritation,
• abdominal pain, diarrhoea, nausea (feeling unwell), vomiting,
• itching,
• increased sweating,
• back pain, chest pain,
• fatigue,
• sensation of warmth, and
• pain at the injection site.

Rare side effects (may affect more than 1 in 1,000 people)

• Numbness, tingling and/or burning sensation,
• heart rate irregularities, palpitations (awareness of heartbeat, stronger or irregular),
• feeling faint,
• increased blood pressure,
• cold sensation in extremities,
• breathing problems, cough, dry throat, difficulty swallowing,
• rash, skin redness,
• joint pain, flank pain (hips), neck pain, muscle cramps, fever, muscle stiffness,
• and abnormal electrocardiogram.

Not known (frequency cannot be estimated from available data)

• Loss of consciousness,
• facial numbness,
• swelling of the eyes,
• and altered vision.

These side effects usually disappear rapidly without any treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luminity

Keep Luminity out of the sight and reach of children.
Do not use Luminity after the expiry date stated on the carton and label following the word
"Exp".
Before activation (shaking), store in a refrigerator (2 °C - 8 °C).
After activation (shaking), do not store above 30 °C.
The dispersion must be administered within 12 hours of activation (shaking).
The medicine may be reactivated up to 48 hours after the initial activation and may be used up to 12
hours after the second activation.

6. Package contents and other information

What Luminity contains
The active substance is perflutren. Each ml contains lipid microbubbles containing up to 6.4 x 10⁸ of perflutren, with a mean diameter between 1.1 and 2.5 microns. The approximate amount of gaseous perflutren in each ml of Luminity is about 150 microliters.
The excipients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-
glycero-3-phosphatidic acid monosodium salt (DPPA), N-(methoxypolyethyleneglycol 5000 carbamyl)-1,2-
dipalmitoyl-sn-glycero-3-phosphatidylethanolamine monosodium salt (MPEG5000 DPPE), monosodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
Description of the appearance of Luminity and contents of the pack
Luminity is a gas and solvent for injectable dispersion or infusion. Before activation (agitation), Luminity appears as a colourless liquid, uniformly clear to translucent. After activation (agitation), the product appears as a white, milky liquid.
It is supplied in packs containing one or four 1.5 ml single-dose vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Lantheus EU Limited
Rocktwist House,
Block 1, Western Business Park
Shannon, Co. Clare V14 FW97
Ireland
Tel: +353 1 223 3542
Manufacturer
Millmount Healthcare Limited
Block 7, City North Business Campus
Stamullen, Co. Meath K32 YD60
Ireland
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended for healthcare professionals only:

It is essential to follow the instructions for use and handling of Luminity and to comply with strict aseptic procedures during preparation. As with all parenteral medicinal products, the vials should be inspected visually for particulate matter and to check the integrity of the vial. Prior to administration, the medicinal product must be activated using Vialmix, a mechanical mixing device. Vialmix is not included in the Luminity packaging but will be supplied to healthcare personnel along with the pack order.

Luminity is activated using Vialmix, which is programmed to mix for 45 seconds. Vialmix will alert the operator if the mixing frequency decreases by 5% or more from the set frequency. Vialmix is also programmed to shut off and will provide audible and visual alerts if the mixing frequency exceeds the set frequency by more than 5% or falls below it by 10% or more.

Activation and administration procedure

• The vial must be activated using Vialmix. Immediately after activation, Luminity appears as a white, milky dispersion.

Note: If the medicinal product remains undisturbed for more than 5 minutes after activation, it must be resuspended by manual agitation for 10 seconds before withdrawing from the vial with a syringe. Luminity must be used within 12 hours after activation. The medicinal product may be reactivated up to 48 hours after the first activation and may be used for up to 12 hours after the second activation, depending on whether it has been stored refrigerated or at room temperature. After activation, do not store the vial at temperatures above 30 °C.

• The vial must be pierced with a sterile syringe needle or a sterile, non-siliconized mini-spike adaptor before aspirating the dispersion.
• The dispersion must be withdrawn from the vial using a syringe with a sterile 18 to 20 G needle or connected via a sterile, non-siliconized mini-spike adaptor. If using a needle, it must be positioned to aspirate material from the center of the liquid with the vial inverted. Do not inject air into the vial. The medicinal product must be used immediately after withdrawal from the vial.
• Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.

The content of the vial is intended for single administration only.
Any unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local legal requirements.