LYSAKARE 25 G/25 G SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

LysaKare 25 g/25 g Solution for Infusion

arginine hydrochloride / lysine hydrochloride

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 further questions, ask your doctor.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is LysaKare and what is it used for

What is LysaKare

LysaKare contains the active substances arginine and lysine, two different amino acids. It belongs to a group of medicines used to reduce the side effects of an anticancer medicine.

What is LysaKare 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 tumors.

2. What you need to know before you start using LysaKare

Follow your doctor's instructions carefully. Since you will be receiving another treatment, Lutathera, with LysaKare, read the package leaflet of Lutathera and this package leaflet carefully.If you have any other questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

Do 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 (hyperkalemia).

Warnings and precautions

If any of the following apply to you, inform your doctor before LysaKare is administered to you:

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

Tell 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 problems thinking clearly (signs and symptoms of metabolic acidosis).
• if you have difficulty breathing, weakness, numbness, chest pain, palpitations, and/or an abnormal heart rhythm (signs and symptoms of high levels of potassium in the blood (hyperkalemia)).

Follow your doctor's advice on how much to drink on the day of your treatment to stay well-hydrated.

If you are 65 years of age or older, you are more likely to have kidney problems, and your doctor will determine, based on the results of your blood tests, whether you can receive treatment with LysaKare.

Monitoring before and during your treatment with LysaKare

Your doctor will ask you to have an initial blood test to check if you are eligible for this treatment and subsequent periodic blood tests during treatment to detect any side effects as soon as possible. If necessary, your heart's electrical activity will also be checked with a test called an electrocardiogram (ECG). Based on the results, your doctor may decide to stop the treatment.

The doctor will determine your potassium level in the blood and correct it at the start of the infusion if it is too high. The doctor will also determine the function of the kidneys and liver before starting the infusion. To learn about other tests that need to be done before treatment, read the package leaflet of Lutathera.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years of age because it is not known if 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine, as Lutathera must not be used in pregnant women because radiation is hazardous to the fetus, and breastfeeding should be avoided during treatment with Lutathera.

Driving and using machines

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

3. How to use LysaKare

The recommended dose of LysaKare solution is 1 l (1,000 ml). You must receive the full dose of LysaKare, regardless of any possible adjustments to the dose of Lutathera.

LysaKare is administered by infusion (drip) into a vein. The infusion of LysaKare will start 30 minutes before the administration of Lutathera and will last 4 hours.

Patients who receive amino acid infusions often experience nausea and vomiting. Therefore, you will be given medicines to prevent nausea and vomiting 30 minutes before the infusion of LysaKare.

If you receive more LysaKare than you should

LysaKare will be administered in a controlled clinical setting and is supplied in a single-dose bag. Therefore, it is unlikely that you will receive more infusion than you should, as your doctor will monitor you during treatment. However, in case of overdose, you will receive the appropriate treatment.

If you have any other questions about 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

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

• high levels of potassium (seen in blood tests)
• abdominal pain (stomach pain)

• dizziness

Other possible side effects

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

• headache,
• flushing.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this package 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. Storage of 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 is the last day of the month shown.

Store below 25°C.

You will not need to store this medicine. The storage, use, and disposal of this medicine in appropriate facilities are the responsibility of the healthcare professional. You will receive LysaKare in a controlled clinical setting.

The following information is intended for the healthcare professional responsible for your care.

Do not use this medicine:

• if you notice that the solution is cloudy or contains sediment.
• if the packaging has been previously opened or is damaged.
• if the infusion bag is damaged or leaking

6. Contents of the pack and other information

Composition of LysaKare

• The active substances are arginine and lysine.

A 25 ml bag contains 20.7 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.

• The other ingredient is water for injections.

Appearance and packaging of the product

LysaKare 25 g/25 g solution for infusion is a clear and colorless 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

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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this package leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.