InfoCons Consumer Protection informs you – LysaKare – Package Leaflet

Before anything else

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 a ny further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet . See section 4.

ℹ️ 1. What LysaKare is and what it is used for

What LysaKare is LysaKare con tains the active substance s arginine and lysine, two different amino acids . It belong s to a group of medicines which are used to reduce the side effects of anti -cancer medicine.

What LysaKare is used for

LysaKare is used in adult patients to protect the kidneys from unnecessary radiation during treatment with Lutathera ( lutetium (177Lu) oxodotreotide ), a radioactive medicine used to treat certain tumours .

⚠️ 2. What you need to know before you are given LysaKare

Follow all of your doctor’s instructions carefully. As you will receive another treatment , Lutathera , with LysaKare, read the Lutathera leaflet carefully as well as this leaflet.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

You should not be given 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 blood levels of potassium (hyperkalaemia) .

Warnings and precautions

If any of these apply to you, tell your doctor before you are given LysaKare:

• if you have swollen feet and ankles, too much urine or not enough urine, itching or trouble catching your breath (signs and symptoms of chronic kidney disease).
• if you have itch ing, yellow skin or if the whites of your eye s turn yellow, if you have nausea or vomiting, fatigue, loss of appetite, pain in the upper right side of your stomach area (abdomen), dark or brown urine, or if you bleed or bruise more easily than normal (signs and symptoms of liver disease).
• if you have breathlessness, difficulty breathing when lying down and swelling of the feet or legs (signs and symptoms of heart failure).

21 Tell your doctor immediately if you get any of these symptoms during treatment with LysaKare:

• if you feel tired, lose your appetite, notice changes in your heartbeat, and/or have trouble thinking clearly (signs and symptoms of metabolic acidosis).
• if you have breathlessness, weakness, numbness, chest pain, palpitations and/or abnormal heart rhythm (signs and symptoms of high blood potassium level (hyperkalaemia)).

Follow your doctor’s advice on how much to drink on the day of your treatment so you stay well hydrated .

If you are aged 65 years or above, you may be more likely to have kidney problems, and your doctor will determine on the basis of the blood test results whether you can receive LysaKare treatment.

Monitoring before and during your treatment with LysaKare Your doctor will ask you to have an initial blood test to check whether you are eligible for this treatment and then regular blood tests during treatment to detect any side effects as early as possible. If necessary, the electrical activity of your heart will also be checked with a test called an electrocardiogram (ECG). Based on the results, your doctor may decide to st op the treatment.

The doctor will check your blood potassium level and correct it before starting the infusion if it is too high. The doctor will also check your kidney and liver function before starting the infusion. For other tests which need to be performed before your treatment, please read the Lutathera leaflet.

Children and adolescents

This medicine should not be given to children and adolescents under 18 years old because it is not known whether it is safe and effective in this age group.

Other medicines and LysaKare

Tell your doctor if you are taking , have recently taken , or might take any other medicines .

Pregnancy, breast -feeding, and fertility If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine since Lutathera must not be used in pregnant women because radiat ion is dangerous for the unborn baby and breast -feeding must be avoided during treatment with Lutathera.

Driving and using machines

It is considered unlikely that LysaKare will affect your ability to drive or to use machines.

💊 3. How LysaKare is given

The recommended dose of LysaKare solution is 1 L (1 000 mL). You should receive the full LysaKare dose, regardless of any Lutathera dose adjustments.

LysaKare is given as an infusion (drip) into a vein. The infusion of LysaKare will start 30 minu tes before you are given Lutathera, and will last over a 4 -hour period.

Patients who receive amino acid infusions commonly experience nausea and vomiting. You will therefore be given medicines to prevent nausea and vomiting 30 minutes before the LysaKare infusion.

If you receive more LysaKare than you should LysaKare will be given in a controlled clinical setting and is provided as a single dose bag. It is therefore unlikely that you will receive more of the infusion than you should as your doctor will monitor you during the treatment. However, in the event of an overdose, you will receive the appropriate treatment.

22 If you have any further questions on the use of this medicine , ask your doctor.

❗ 4. Possible side effects

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

Some side effects could be serious

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

• vomiting
• nausea

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

• high potassium levels (seen in blood tests)
• abdominal (belly) pain
• dizziness Other possible side effects

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

• headache
• flushing

Reporting of side effects

If you get any side effects , talk to your doctor . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the label after EXP. The expiry date refers to the last day of that month.

Store below 25°C.

You will not have to store this medicine. Th e correct storage, use and disposal of this medicine are under the responsibility of the specialist in appropriate premises. You will receive LysaKare in a controlled clinical setting.

The following information is intended for the healthcare specialist charged with your care.

Do not use this medicine

• if you notice that the solution is cloudy or has deposits.
• if the overwrap has been previously opened or damaged.
• if the infusion bag is damaged or leaking .

📦 6. Contents of the pack 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 ingredient is water for injection s.

What LysaKare looks like and contents of the pack

LysaKare 25 g/25 g solution for infusion is a clear and colourless solution free from visible particles , and is supplied in a single -use flexible plastic bag.

Each infusion bag contains 1 L of LysaKare solution.

Marketing authorisation holder

Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 Nuremberg Germany Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 България Novartis Bulgaria EOOD Тел: +359 2 489 98 28 Luxembourg/Luxemburg Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11 Česká republika Novartis s.r.o.

Tel: +420 225 775 111 Magyarország Novartis Hungária Kft.

Tel.: +36 1 457 65 00 Danmark Novartis Sverige AB Tlf.: +46 8 732 32 00 Malta Novartis Pharma Services Inc.

Tel: +356 2122 2872 Deutschland Novartis Pharma GmbH Tel: +49 911 2730 Nederland Novartis Pharma B.V.

Tel: +31 88 04 52 111 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 Norge Novartis Sverige AB Tlf: +46 8 732 32 00 24 Ελλάδα ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Τηλ: +30 22920 63900 ή Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 España Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00 Polska Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888 France Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00 Portugal Novartis Farma – Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600 Hrvatska Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220 România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 Slovenija Novartis Pharma Services Inc.

Tel: + 386 1 300 75 50 Ísland Novartis Sverige AB Sími: +46 8 732 32 00 Slovenská republika Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439 Italia Novartis Farma S.p.A.

Tel: +39 02 96 54 1 Suomi/Finland Novartis Sverige AB Puh/Tel: +46 8 732 32 00 Κύπρος ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Τηλ: +30 22920 63900 ή Novartis Pharma Services Inc.

Τηλ: +357 22 690 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 Latvija SIA Novartis Baltics Tel: +371 67 887 070

This leaflet was last revised i n

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information LysaKare (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1381).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.