LYSAKARE SOLUTION FOR INFUSION 25G 25G

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

L-Arginine Hydrochloride; L-Lysine Hydrochloride

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

V03AF11

Pharmaceutical form:

INFUSION, SOLUTION

Composition:

L-Arginine Hydrochloride 25 g/L; L-Lysine Hydrochloride 25 g/L

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

LABORATOIRE BIOLUZ

Authorization status:

ACTIVE

Authorization date:

2020-08-31

Summary of Product characteristics

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Lysakare Aug 2019.SINv1
Page 1 of 7
1
TRADENAME
LysaKare
®
25 g/25 g solution for infusion
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Solution for infusion (infusion).
Clear, colorless solution, free from visible particles.
pH: 5.1 to 6.1
Osmolality: 420 to 480 mOsm/kg
ACTIVE SUBSTANCES
One 1,000 mL infusion bag contains 25 g of L-arginine hydrochloride
(equivalent to 20.7 g
arginine) and 25 g of L-lysine hydrochloride (equivalent to 20 g
lysine).
EXCIPIENTS
Water for injections.
3
INDICATIONS
LysaKare is indicated for reduction of renal radiation exposure during
peptide-receptor
radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in
adults.
4
DOSAGE REGIMEN AND ADMINISTRATION
Since
LysaKare
is
indicated
for
administration
during
PRRT
with
lutetium
(177Lu)
oxodotreotide, it should only be administered by a healthcare provider
experienced in the use
of PRRT.
Please refer to full prescribing information of lutetium (177Lu)
oxodotreotide.
DOSAGE REGIMEN
GENERAL TARGET POPULATION
ADULTS
The recommended treatment regimen in adults consists of infusion of a
full bag of LysaKare
concomitantly with lutetium (177Lu) oxodotreotide. The dose of
LysaKare should not be
decreased even if the dose of lutetium (177Lu) oxodotreotide is
reduced.
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Lysakare Aug 2019.SINv1
Page 2 of 7
Pre-treatment
with
an
antiemetic
is
recommended
to
prevent
nausea
and
vomiting.
Antiemetics should be administered with sufficient lead time prior to
the start of LysaKare.
Please
refer
to
the
full
prescribing
information
of
the
antiemetic
for
administration
instructions.
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
Lysa