Lutathera
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
20-03-2024
Karatteristiċi tal-prodott
(SPC)
20-03-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
17-01-2018
Ingredjent attiv:
lutetium (177Lu) oxodotreotide
Disponibbli minn:
Advanced Accelerator Applications
Kodiċi ATC:
V10XX04
INN (Isem Internazzjonali):
lutetium (177Lu) oxodotreotide
Grupp terapewtiku:
Other therapeutic radiopharmaceuticals
Żona terapewtika:
Neuroendocrine Tumors
Indikazzjonijiet terapewtiċi:
Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP‑NETs) in adults.
Sommarju tal-prodott:
Revision: 10
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2017-09-26
Fuljett ta 'informazzjoni
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LUTATHERA 370 MBQ/ML SOLUTION FOR INFUSION
lutetium (
177
Lu) oxodotreotide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or other healthcare
professional who will
supervise the procedure.
-
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 Lutathera is and what it is used for
2.
What you need to know before Lutathera is used
3.
How Lutathera is used
4.
Possible side effects
5.
How Lutathera is stored
6.
Contents of the pack and other information
1.
WHAT LUTATHERA IS AND WHAT IT IS USED FOR
WHAT LUTATHERA IS
Lutathera contains lutetium (
177
Lu) oxodotreotide. This medicine is a radiopharmaceutical product for
therapy only.
WHAT LUTATHERA IS USED FOR
Lutathera is used for the treatment of adults with certain tumours
(gastroenteropancreatic
neuroendocrine tumours), which cannot be completely removed from your
body by surgery, have
spread in your body (metastatic) and do not respond any more to your
current treatment.
HOW LUTATHERA WORKS
The tumour needs to have somatostatin receptors on the surface of its
cells in order for the medicine to
be effective. Lutathera binds with these receptors and emits
radioactivity directly into the tumour cells,
causing their death.
The use of Lutathera involves exposure to amounts of radioactivity.
Your doctor and the nuclear
medicine doctor have considered that the clinical benefit that you
will obtain from the procedure with
the radiopharmaceutical outweighs the risk due to radiation.
2.
WHAT YOU NEED TO KNOW BEFORE LUTATHERA IS USED
LUTATHERA MUST NOT BE USED
-
if you are allergic to lutetium (
177
Lu) oxodotreotide or any of the other ingredients of this
medicine (listed in section 6).
-
if you are pregnant, think you
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lutathera 370 MBq/mL solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 370 MBq of lutetium (
177
Lu) oxodotreotide at the date and time of
calibration.
The total amount of radioactivity per single-dose vial is 7 400 MBq at
the date and time of infusion.
Given the fixed volumetric activity of 370 MBq/mL at the date and time
of calibration, the volume of
the solution in the vial ranges between 20.5 and 25.0 mL in order to
provide the required amount of
radioactivity at the date and time of infusion.
Physical characteristics
Lutetium-177 has a half-life of 6.647 days. Lutetium-177 decays by β
-
emission to stable hafnium-177
with the most abundant β
-
(79.3%) having a maximum energy of 0.498 MeV. The average beta energy
is approximately 0.13 MeV. Low gamma energy is also emitted, for
instance at 113 keV (6.2%) and
208 keV (11%).
Excipient with known effect
Each mL of solution contains up to 0.14 mmol (3.2 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lutathera is indicated for the treatment of unresectable or
metastatic, progressive, well-differentiated
(G1 and G2), somatostatin receptor-positive gastroenteropancreatic
neuroendocrine tumours
(GEP-NETs) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Important safety instructions
Lutathera should be administered only by persons authorised to handle
radiopharmaceuticals in
designated clinical settings (see section 6.6) and after evaluation of
the patient by a qualified
physician.
Patient identification
Before starting treatment with Lutathera, somatostatin receptor
imaging (scintigraphy or positron
emission tomography [PET]) must confirm the overexpression of these
receptors in the tumour tissue
with the tumour uptake at least as high as normal liver uptake.
3
Posology
_Adults _
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