LysaKare

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

L-arginine hydrochloride, L-lysine hydrochloride

Disponível em:

Advanced Accelerator Applications

Código ATC:

V03AF11

DCI (Denominação Comum Internacional):

arginine, lysine

Grupo terapêutico:

Detoxifying agents for antineoplastic treatment

Área terapêutica:

Radiation Injuries

Indicações terapêuticas:

LysaKare is indicated for reduction of renal radiation exposure during Peptide-Receptor Radionuclide Therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.

Resumo do produto:

Revision: 4

Status de autorização:

Authorised

Data de autorização:

2019-07-25

Folheto informativo - Bula

17
B. PACKAGE LEAFLET
18
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 (
177
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

Características técnicas

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 (
177
Lu) oxodotreotide in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
LysaKare is indicated for administration with PRRT with lutetium (
177
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 (
177
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 (
177
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 hyperkalaemia
in these patients (see section 4.4).
3
_Paediatric population _
The safety and effic