Lysakare

Package leaflet: Information for the patient

LysaKare 25 g/25 g solution for infusion

L-arginine hydrochloride / L-lysine hydrochloride
Please read this leaflet carefully before 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, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What LysaKare is and what it is used for
2. What you need to know before receiving LysaKare
3. How LysaKare is administered
4. Possible side effects
5. How to store LysaKare
6. Contents of the pack and other information

1. What LysaKare is and what it is used for

What LysaKare is
LysaKare contains the active substances arginine and lysine, two different amino acids. It belongs to a group
of medicines used to reduce the unwanted effects of anticancer drugs.
What LysaKare is used for
LysaKare is used in adult patients to protect the kidneys from unnecessary radiation during treatment with Lutathera (lutetium (Lu) oxodotreotide), a radioactive medicine used to treat certain tumours.

2. What you need to know before receiving LysaKare

Follow your doctor's instructions carefully. Since you will be receiving another treatment,
Lutathera, together with LysaKare, read the Lutathera package leaflet carefully along with this
leaflet.
If you have any doubts about the use of this medicine, consult your doctor, nurse, or
pharmacist.
You must not receive LysaKare

• if you are allergic to arginine, lysine, or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of potassium in your blood (hyperkalaemia).

Warnings and precautions
If any of the following conditions apply to you, inform your doctor before receiving LysaKare:

• if you have swollen feet and ankles, urinate too much or too little, have itching, or breathing problems (signs and symptoms of chronic kidney disease).
• if you have itching, yellowing of the skin or whites of the eyes, nausea or vomiting, fatigue, loss of appetite, pain in the upper right part of the stomach (abdomen), dark or brown-coloured urine, or if you bleed or bruise more easily than normal (signs and symptoms of liver disease).
• if you experience shortness of breath, difficulty breathing when lying down, or swelling of the feet or legs (signs and symptoms of heart failure).

Inform your doctor immediately if you experience any of the following symptoms during treatment
with LysaKare:

• if you feel tired, lose your appetite, notice changes in your heartbeat and/or have difficulty thinking clearly (signs and symptoms of metabolic acidosis).
• if you experience shortness of breath, weakness, numbness, chest pain, palpitations and/or irregular heartbeat (signs and symptoms of high potassium levels in the blood (hyperkalaemia)).

Follow your doctor’s advice on how much to drink on the day of treatment to stay well hydrated.
If you are 65 years of age or older, you may be at higher risk of kidney problems, and based on blood test results, your doctor will determine whether you can receive treatment with
LysaKare.
Monitoring before and during treatment with LysaKare
Your doctor will request an initial blood test to check whether you are eligible for this treatment, followed by regular blood tests during treatment to detect any side effects early. If necessary, your heart's electrical activity will also be monitored with a test called an electrocardiogram (ECG). Based on the results, your doctor may decide to discontinue treatment.
Your doctor will check and correct your blood potassium levels before starting the infusion if they are too high. Your doctor will also assess your kidney and liver function before starting the infusion. For other tests required before treatment, please refer to the Lutathera package leaflet.
Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age, as it is not known whether it is safe and effective in this age group.
Other medicines and LysaKare
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine, as Lutathera must not be used in pregnant women because radiation is harmful to the unborn child, and breastfeeding must be avoided during treatment with Lutathera.
Driving and using machines
It is unlikely that LysaKare will affect your ability to drive or use machines.

3. How LysaKare is administered

The recommended dose of LysaKare solution is 1 L (1,000 mL). You must receive the full dose of
LysaKare, regardless of any dose adjustment of Lutathera.
LysaKare is administered as an intravenous infusion (drip). The LysaKare infusion will start
30 minutes before the administration of Lutathera and will last for a period of 4 hours.
Nausea and vomiting are commonly observed in patients receiving amino acid infusions.
Therefore, 30 minutes before the LysaKare infusion, you will be given medications to
prevent nausea and vomiting.
If you receive more LysaKare than you should
LysaKare will be administered in a controlled clinical setting and is provided as a single-dose bag.
Therefore, it is unlikely that you will receive more infusion than required, as your doctor will monitor you during treatment. However, in case of overdose, you will receive appropriate treatment.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious

Very common (may affect more than 1 in 10 people):

• vomiting
• nausea

Not known (frequency cannot be estimated from the available data):

• elevated potassium levels (observed in blood tests)
• abdominal pain (stomach)
• dizziness

Other possible side effects
Not known (frequency cannot be estimated from the available data):

• headache
• flushing

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. 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 LysaKare

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
Store below 25°C.
This medicine should not be stored by the patient. Proper storage, use, and disposal of this medicine are the responsibility of healthcare professionals in appropriate facilities. You will receive LysaKare in a controlled clinical setting.
The following information is intended for the healthcare professional in charge of your treatment only.
Do not use this medicine:

• if the solution appears cloudy or contains particles.
• if the outer packaging has been previously opened or damaged.
• if the infusion bag is damaged or shows signs of leakage.

6. Package contents and other information

What LysaKare contains

• The active substances are arginine and lysine. Each infusion bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.
• The other component is water for injections.

Description of the appearance of LysaKare and contents of the pack
LysaKare 25 g/25 g solution for infusion is a clear, colourless solution free from visible particles, supplied in a single-use flexible plastic bag.
Each infusion bag contains 1 L of LysaKare solution.

Marketing Authorisation Holder
Advanced Accelerator Applications
8-10 Rue Henri Sainte-Claire Deville
92500 Rueil-Malmaison
France

Manufacturer
Laboratoire Bioluz
Zone Industrielle de Jalday
64500 Saint Jean de Luz
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SAM Nordic
Tél/Tel: +32 2 246 16 11 Švedija
Tel: +46 8 720 58 22

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
SAM Nordic Novartis Pharma Services Inc.
Sverige Tel: +356 2122 2872
Tel: +46 8 720 58 22

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 2730 Tel: +31 88 04 52 111

Eesti Norge
SAM Nordic SAM Nordic
Rootsi Sverige
Tel: +46 8 720 58 22 Tlf: +46 8 720 58 22

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Advanced Accelerator Applications Ibérica, S.L.U. Advanced Accelerator Applications Polska Sp. z o.o.
Tel: +34 97 6600 126 Tel.: +48 22 275 56 47

France Portugal
Advanced Accelerator Applications Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 63 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel: +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
SAM Nordic MGP, spol. s r.o.
Svíþjóð Tel: +421 254 654 841
Sími: +46 8 720 58 22

Italia Suomi/Finland
Novartis Farma S.p.A. SAM Nordic
Tel: +39 02 96 54 1 Puh/Tel: +46 8 720 58 22
Κύπρος Sverige
Novartis Pharma Services Inc. SAM Nordic
Τηλ: +357 22 690 690 Tel: +46 8 720 58 22

Latvija United Kingdom (Northern Ireland)
SAM Nordic Novartis Ireland Limited
Zviedrija Tel: +44 1276 698370
Tel: +46 8 720 58 22

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.