LysaKare

European Union - English - EMA (European Medicines Agency)

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Active ingredient:
L-Arginine Hydrochloride / L-Lysine Hydrochloride
Available from:
Advanced Accelerator Applications
ATC code:
V03AF11
INN (International Name):
arginine / lysine
Therapeutic group:
Urologicals
Therapeutic area:
Radiation Injuries
Therapeutic indications:
LysaKare is indicated for reduction of renal radiation exposure during Peptide-Receptor Radionuclide Therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.
Authorization status:
Authorised
Authorization number:
EMEA/H/C/004541
Authorization date:
2019-07-25
EMEA code:
EMEA/H/C/004541

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B. PACKAGE LEAFLET

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

What LysaKare is and what it is used for

What you need to know before you take LysaKare

How to take LysaKare

Possible side effects

How to store LysaKare

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 (

Lu) 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.

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.

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

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

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 (

Lu) oxodotreotide in adults.

4.2

Posology and method of administration

LysaKare is indicated for administration with PRRT with lutetium (

Lu) 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 (

Lu) 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

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 (

Lu) oxodotreotide to achieve optimal renal protection.

LysaKare and lutetium (

Lu) 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 (

Lu) 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

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

evere 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 (

Lu) 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 (

Lu) 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 (

Lu) oxodotreotide, please also refer to section 4.4 of the

lutetium (

Lu) oxodotreotide SmPC for further warnings specific to treatment with lutetium (

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

Lu) 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 (

Lu) oxodotreotide.

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.

main

adverse

reactions

which

related

mainly

amino

acid

solution

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.

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 (

Lu) 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 (

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 (

Lu) 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

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

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

Official address

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

An agency of the European Union

Address for visits and deliveries

Refer to www.ema.europa.eu/how-to-find-us

Send us a question

Go to www.ema.europa.eu/contact

Telephone

+31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/378037/2019

EMEA/H/C/004541

LysaKare (arginine / lysine)

An overview of LysaKare and why it is authorised in the EU

What is LysaKare and what is it used for?

LysaKare is a medicine used to protect the kidneys from radiation damage during cancer treatment

with a radioactive medicine called lutetium (

Lu) oxodotreotide.

LysaKare is for use in adults and contains the active substances arginine and lysine.

How is LysaKare used?

LysaKare is given by infusion (drip) in to a vein over 4 hours. Infusion with LysaKare is started

30 minutes before the patient is given lutetium (

Lu) oxodotreotide (also by infusion).

Because LysaKare can cause nausea (feeling sick) and vomiting, patients will be given medicines to

prevent nausea and vomiting before receiving LysaKare.

LysaKare can only be obtained with a prescription and should only be given by a healthcare

professional experienced in the use of radioactive medicines. For more information about using

LysaKare, see the package leaflet or contact your doctor or pharmacist.

How does LysaKare work?

Radiation from lutetium (

Lu) oxodotreotide can cause damage when the medicine passes through

tubules in the kidney. The active substances in LysaKare, arginine and lysine, interfere with the

passage of lutetium (

Lu) oxodotreotide through these kidney tubules. As a result, the radioactive

medicine leaves the body in the urine and the kidneys are exposed to less radiation.

What benefits of LysaKare have been shown in studies?

Because the use of arginine and lysine to protect the kidneys during this type of cancer treatment is

well established, the company presented data from the scientific literature. These included data from

over 1,200 cancer patients treated with lutetium (

Lu) oxodotreotide, which showed that arginine and

lysine were effective at preventing kidney damage.

LysaKare (arginine / lysine)

EMA/378037/2019

Page 2/2

In another published study involving 229 patients, measurement of creatinine clearance (an indication

of how well the kidneys are working) did not show kidney damage 14 months after patients were

treated with arginine and lysine at the same time as lutetium (

Lu) oxodotreotide.

What are the risks associated with LysaKare?

The most common side effects with LysaKare (which may affect more than 1 in 10 people) are nausea

and vomiting. LysaKare is also associated with hyperkalaemia (high blood potassium levels), but the

frequency of this side effect is not known. Side effects with LysaKare are usually mild or moderate.

LysaKare must not be given to patients with high levels of potassium in the blood if this has not been

corrected before treatment.

For the full list of side effects and restrictions with LysaKare, see the package leaflet.

Why is LysaKare authorised in the EU?

The use of arginine and lysine during treatment with lutetium (

Lu) oxodotreotide has been shown to

reduce kidney damage and allow patients to be given an effective dose of radioactive treatment for

their cancer. The main risk with LysaKare is a dangerous rise of blood potassium levels but this side

effect can be managed if recognised and treated appropriately. Information on how to do this has been

included in the product information. The European Medicines Agency therefore decided that LysaKare’s

benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of

LysaKare?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of LysaKare have been included in the summary of product characteristics and the

package leaflet.

As for all medicines, data on the use of LysaKare are continuously monitored. Side effects reported

with LysaKare are carefully evaluated and any necessary action taken to protect patients.

Other information about LysaKare

LysaKare received a marketing authorisation valid throughout the EU on 25 July 2019.

Further information on LysaKare can be found on the Agency’s website:

ema.europa.eu/medicines/human/EPAR/lysakare.

This overview was last updated in 07-2019.

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