LysaKare

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS  

1 



1. NAME OF THE MEDICINAL PRODUCT 
 
LysaKare 25 g/25 g solution for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One 1,000 mL bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for infusion (infusion). 
Clear, colourless solution, free from visible particles 
pH: 5.1 – 6.1 
Osmolarity: 420 – 480 mOsm/L 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
LysaKare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide 
therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults. 
 
4.2 Posology and method of administration 
 
LysaKare is indicated for administration with PRRT with lutetium (177Lu) oxodotreotide therefore, it 
should only be administered by a health care provider experienced in the use of PRRT. 
 
Posology 
 
Adults 
 
The recommended treatment regimen in adults consists of infusion of full bag of LysaKare 
concomitantly with lutetium (177Lu) oxodotreotide infusion, even when patients require PRRT dose 
reduction.  
 
Pre-treatment with an anti-emetic 30 minutes prior to start of LysaKare infusion is recommended to 
reduce the incidence of nausea and vomiting. 
 
Special populations 
 
Renal impairment 
 
Due to the potential for clinical complications related to volume overload and an increase of potassium 
in blood associated with the use of LysaKare, this product should not be administered in patients with 
creatinine clearance <30 mL/min.  
Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 
mL/min. Treatment with lutetium (177Lu) oxodotreotide is not recommended for patients with renal 
function between 30 and 50 mL/min therefore, the benefit risk for these patients will always need to be 
weighed carefully, which should include consideration of an increased risk for transient hyperkalaemia 
in these patients (see section 4.4). 
 
Paediatric population 

2 



 
The safety and efficacy of LysaKare in children less than 18 years have not been established.  
No data are available. 
 
Method of administration  
 
For intravenous use.  
LysaKare should be administered as a 4-hour infusion (250 mL/hour) starting 30 minutes prior to 
administration of lutetium (177Lu) oxodotreotide to achieve optimal renal protection. 
LysaKare and lutetium (177Lu) oxodotreotide must be given through a separate infusion line. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
• Pre-existing clinically significant hyperkalaemia if not adequately corrected before starting the 

LysaKare infusion (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Hyperkalaemia 
 
An increase of serum potassium levels may occur in patients receiving arginine and lysine. Serum 
potassium level increases are generally mild and transient. According to limited available data 
maximum levels should be reached approximatively by 4 to 5 hours after start of the infusion and 
should return to normal levels by 24 hours.  
Serum potassium levels must be tested before each treatment with LysaKare. In case of 
hyperkalaemia, patient’s history of hyperkalaemia and concomitant medication should be checked. 
Hyperkalaemia must be corrected accordingly before starting the infusion (see section 4.3).  
In case of pre-existing clinically significant hyperkalaemia, a second monitoring prior to LysaKare 
infusion must confirm that hyperkalaemia has been successfully corrected. The patient should be 
monitored closely for signs and symptoms of hyperkalaemia, e.g. dyspnoea, weakness, numbness, 
chest pain and cardiac manifestations (conduction abnormalities and cardiac arrhythmias). An ECG 
should be performed prior to discharging the patient.  
Vital signs should be monitored during the infusion regardless of baseline serum potassium levels. 
Patients should be instructed to drink substantial quantities of water (at least 1 glass every hour) on the 
day of infusion to remain hydrated and facilitate excretion of excess serum potassium.  
In case hyperkalaemia symptoms develop during LysaKare infusion, appropriate corrective measures 
must be taken. In case of severe symptomatic hyperkalaemia, discontinuation of LysaKare infusion 
should be considered, taking into consideration the risk-benefit of renal protection versus acute 
hyperkalaemia. 
 
Patients with renal impairment 
 
The use of arginine and lysine has not been specifically studied in patients with renal impairment. 
Arginine and lysine are substantially excreted and reabsorbed by the kidney, and their efficacy in the 
reduction of renal radiation exposure is dependent on this. Due to the potential for clinical 
complications related to volume overload and an increase of potassium in blood associated with the 
use of LysaKare, this product should not be administered in patients with creatinine clearance 
<30 mL/min. Kidney function (creatinine and creatinine clearance) should be tested before each 
administration. 
Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 
50 mL/min. Treatment with lutetium (177Lu) oxodotreotide is not recommended for patients with renal 
function between 30 and 50 mL/min therefore, the benefit risk for these patients will always need to be 
weighed carefully, which should include consideration of an increased risk for transient hyperkalemia 
in these patients. 
 
Patiens with hepatic impairment 

3 



 
The use of arginine and lysine has not been studied in patients with severe hepatic impairment. Liver 
function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin, bilirubin) 
should be tested before each administration. 
Care should be taken with LysaKare use in patients with severe hepatic impairment and in case of 
either total bilirubinemia >3 times the upper limit of normal or albuminemia <30 g/L and prothrombin 
ratio <70% during treatment. Treatment with lutetium (177Lu) oxodotreotide is not recommended in 
these circumstances.  
 
Heart failure  
 
Due to potential for clinical complications related to volume overload care should be taken with use of 
arginine and lysine in patients with severe heart failure defined as class III or class IV in the NYHA 
classification.  
Treatment with lutetium (177Lu) oxodotreotide is not recommended for patients with severe heart 
failure defined as class III or class IV in the NYHA classification therefore, the benefit risk for these 
patients will always need to be weighed carefully. 
 
Elderly  
 
Because elderly patients are more likely to have decreased renal function, care should be taken in 
determining eligibility based on creatinine clearance.  
 
Metabolic acidosis 
 
Metabolic acidosis has been observed with complex amino-acid solutions administered as part of total 
parenteral nutrition (TPN) protocols. Shifts in acid-base balance alter the balance of extracellular-
intracellular potassium and the development of acidosis may be associated with rapid increases in 
plasma potassium. 
 
As LysaKare is administered with lutetium (177Lu) oxodotreotide, please also refer to section 4.4 of the 
lutetium (177Lu) oxodotreotide SmPC for further warnings specific to treatment with lutetium (177Lu) 
oxodotreotide. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
No interaction with other medicinal product is expected since there is no information that other drugs 
are re-absorbed by the same kidney re-absorption mechanism. 
 
4.6 Fertility, pregnancy and lactation 
 
There is no relevant use of this medicinal product in women of childbearing potential since lutetium 
(177Lu) oxodotreotide is contraindicated during established or suspected pregnancy or when pregnancy 
has not been excluded due to the risk associated with the ionizing radiation (see section 4.1). 
 
Pregnancy  
 
There are no data on the use of arginine and lysine in pregnant women.  
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). 
 
Breast-feeding 
 
Arginine and lysine, being naturally occurring amino acids, are excreted in human milk, but effects on 
the breastfed newborns/infants are unlikely. Breast-feeding should be avoided during treatment with 
lutetium (177Lu) oxodotreotide. 
 

4 



Fertility 
 
There are no data on the effects of arginine and lysine on fertility. 
 
4.7 Effects on ability to drive and use machines 
 
LysaKare has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
There are very limited data on the safety profile of arginine and lysine solution for infusion without 
concomitant administration of PRRT, which also includes the use of anti-emetics as pre-medication 
and often the concomitant use of short acting somatostatin analogues. 
The main adverse reactions which are related mainly to the amino acid solution are nausea 
(approximately 25%), vomiting (approximately 10%) and hyperkalaemia. These adverse reactions are 
mostly mild to moderate. 
 
Tabulated list of adverse reactions  
 
The adverse reactions listed below have been identified in publications of studies with amino acid 
solutions with the same composition with regards to the amino acid content, involving over 
900 patients receiving more than 2,500 doses of arginine and lysine during PRRT with various 
radiolabelled somatostatin analogues.  
  
The adverse reactions are listed according to the frequency. The frequencies are categorised as 
follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare 
(≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available 
data). 
 
Table 1  Adverse drug reactions 

 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
In the event of over-hydration or solute overload, the elimination should be promoted by frequent 
micturition or by forced diuresis and frequent bladder voiding. 

Adverse drug reaction Frequency category   
Metabolism and nutrition disorders   
Hyperkalaemia Not known   
Nervous system disorders   
Dizziness Not known   
Headache Not known   
Vascular disorders    
Flushing Not known   
Gastrointestinal disorders   
Nausea Very common   
Vomiting Very common   
Abdominal pain  Not known   

5 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: All other therapeutic products, detoxifying agents for antineoplastic 
treatment, ATC code: V03AF11 
 
Mechanism of action 
 
Arginine and lysine undergo glomerular filtration and, via competition, interfere with renal resorption 
of lutetium (177Lu) oxodotreotide, reducing the radiation dose delivered to the kidney.  
 
Clinical efficacy and safety 
 
Clinical efficacy and safety for arginine and lysine are based on published literature of studies using 
solutions with the same arginine and lysine content as LysaKare.  
The toxicities that are observed following administration of PRRT are directly due to radiation-
absorbed dose to organs. The kidneys are the critical organs for toxicity for lutetium (177Lu) 
oxodotreotide and dose limiting if amino acids are not administered to reduce renal uptake and 
retention.  
A dosimetry study including 6 patients showed that a 2.5% Lysine-Arginine amino acid solution 
reduced renal radiation exposure by about 47% as compared to no treatment, without having an effect 
on tumour uptake of lutetium (177Lu) oxodotreotide. This reduction in renal radiation exposure 
mitigates the risk for radiation-induced renal injury.  
Based on a publication of the largest study using arginine and lysine in the same quantities as 
LysaKare, the average kidney absorbed dose, as determined by planar imaging dosimetry, was 
20.1±4.9 Gy, which is below the established threshold for the occurrence of renal toxicities of 23 Gy. 
 
5.2 Pharmacokinetic properties 
 
Arginine and lysine are naturally occurring amino acids that follow physiological pharmacokinetic 
steps and biochemical processes after infusion. 
 
Absorption 
 
Due to the intravenous route of administration, LysaKare is 100% bioavailable. 
 
Distribution 
 
Transient elevations in plasma arginine and lysine are observed after intravenous administration, 
whereupon the highly water soluble amino acids are quickly distributed throughout tissues and body 
fluid.  
 
Biotransformation 
 
Like other naturally occurring amino acids, arginine and lysine serve as building blocks in protein 
anabolism and serve as precursors for several other products, including nitric oxide, urea, creatinine, 
and Acetyl-Coenzyme A. 
 
Elimination 
 
Arginine and lysine are rapidly distributed. Based on a study with 30 g arginine infused over 
30 minutes, plasma elimination of amino acids follows at least a biphasic or triphasic decline, with 
levels returning to baseline within 6 hours post-dose. Initial rapid clearance is through glomerular 

6 



filtration in the kidney in the first 90 minutes post-infusion. Remaining amino acid is removed by non-
renal clearance. 
 
Paediatric population  
 
No pharmacokinetic data are available on the use of arginine and lysine at the same dose as LysaKare 
and for the same indication in paediatric patients.  
 
5.3 Preclinical safety data 
 
There were no non-clinical studies conducted with LysaKare. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.  
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
Store below 25°C. 
 
6.5 Nature and contents of container  
 
Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a 
polyethylene polyamine/aluminium foil.  
 
6.6 Special precautions for disposal 
 
This medicinal product is for single use only.  
Do not remove unit from overwrap until ready to use.  
Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. 
Do not reconnect partially used bags. 
LysaKare must not be diluted. 
Do not use solutions which are cloudy or have deposits. This may indicate that the product is unstable 
or that the solution has become contaminated. 
Once the container has been opened, the contents should be used immediately. 
  
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Advanced Accelerator Applications 
20 rue Diesel 
01630 Saint Genis Pouilly 

7 



France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1381/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: {DD month YYYY} 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 

Detailed information on this medicinal product is available on the website of the European 
Medicines Agency http://www.ema.europa.eu.  

8 

http://www.ema.europa.eu/


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 
A. MANUFACTURER RESPONSIBLE FOR BATCH 

RELEASE  
 
B. CONDITIONS OR RESTRICTIONS REGARDING 

SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF 

THE MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD 

TO THE SAFE AND EFFECTIVE USE OF THE 
MEDICINAL PRODUCT 
 

9 



A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Laboratoire Bioluz 
Zone Industrielle de Jalday 
64500 Saint Jean de Luz 
France 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached. 

 
  

10 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  

11 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  

12 



PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Polyethylene polyamine/aluminium foil 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
LysaKare 25 g/25 g solution for infusion   
L-arginine hydrochloride/L-lysine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each bag of 1,000 mL contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipient: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for infusion  
1,000 mL 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use. 
For single use only. 
Do not remove from overwrap until ready for use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not reconnect partially used bags. 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. 
 

13 



 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Advanced Accelerator Applications 
20 rue Diesel 
01630 Saint Genis Pouilly 
France  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1381/001 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
  

14 



PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Polyvinyl chloride (PVC) infusion bag 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
LysaKare 25 g/25 g solution for infusion   
L-arginine hydrochloride/L-lysine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each bag of 1,000 mL contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipient: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for infusion  
1,000 mL 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use. 
For single use only. 
Do not remove from overwrap until ready for use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not reconnect partially used bags. 
 
 
8. EXPIRY DATE 
 
EXP:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. 
 

15 



 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Advanced Accelerator Applications 
20 rue Diesel 
01630 Saint Genis Pouilly 
France  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1381/001 
 
 
13. BATCH NUMBER 
 
Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  

16 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 

17 



Package leaflet: Information for the patient 
 

LysaKare 25 g/25 g solution for infusion 
L-arginine hydrochloride/L-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 get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
What is in this leaflet 
1. What LysaKare is and what it is used for  
2. What you need to know before you take LysaKare  
3. How to take LysaKare  
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 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 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 take 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 and 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  
Talk to your doctor before taking LysaKare if your kidneys, heart or liver are severely impaired or if 
you have a history of high blood levels of potassium (hyperkalaemia). 
Because feeling sick (nausea) and vomiting are commonly seen with amino acid infusions, you will be 
given medicines to prevent nausea and vomitting 30 minutes before the LysaKare infusion.  
 
The doctor will check your blood potassium levels, and will correct them if they are too high before 
starting the infusion. 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. 
Follow your doctor’s advice on how much fluid to drink on the day of your treatment so you stay well 
hydrated. 
 

18 



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. 
 
Driving and using machines 
It is considered unlikely that LysaKare will affect your ability to drive or to use machines. 
 
 
3. How to take LysaKare 
 
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 minutes 
before you are given Lutathera, and will last over a 4 hour period.  
 
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 case of an overdose, you will receive the 
appropriate treatment. 
 
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.  
 
Very common (may affect more than 1 in 10 people):  
• nausea (feeling sick) and vomiting  
 
Not known (frequency cannot be estimated from the available data):  
• high potassium levels seen in blood tests, abdominal (belly) pain, headache, dizziness and 

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. 
LysaKare should be stored below 25°C. 
You will not have to store this medicine. The 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.  

19 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


The following information is intended for the healthcare specialist charged with your care. 
Do not use this medicine:  
- if you notice the solution is cloudy or has deposits.  
- if 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 injections. 
 
What LysaKare looks like and contents of the pack 
LysaKare is a clear and colourless solution for infusion, supplied in a single use flexible plastic bag. 
Each infusion bag contains 1 L LysaKare of solution. 
 
Marketing Authorisation Holder  
Advanced Accelerator Applications 
20 rue Diesel 
01630, Saint Genis Pouilly 
France 
 
Manufacturer 
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: 
 
AT, BE, BG, CZ, FR, HR, HU, IS, LU, 
LV, LT, MT, NL, RO, SI, SK 
Advanced Accelerator Applications 
Tel/Tél/ Teл/Sími: + 33 4 50 99 30 70 
 
CY, EL 
ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ 
Τηλ: +30 22920 63900 
 
DE 
Advanced Accelerator Applications Germany GmbH 
Tel: +49 228 925 88 30 
 
DK, EE, FI, NO, SE 
SAM Nordic 
Tel Puh/Tlf: +46-8-7205822 
 
ES 
Advanced Accelerator Applications Ibérica, S.L.U. 
Tel: + 34 976 600 126 
 

IE, UK 
Advanced Accelerator Applications UK Limited 
Tel: + 44 1761 404 277 
 
IT 
Advanced Accelerator Applications (Italy) S.r.l 
Tel: + 39 0125 5612 11 
 
PL 
Advanced Accelerator Applications Polska Sp. z o. o. 
Tel: +48 22 57 21 555 
 
PT 
Advanced Accelerator Applications (Portugal) 
Unipessoal, Lda 
Tel: + 351 211212018 
 

 
This leaflet was last revised in {month YYYY}. 

20 



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

21 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET