Unituxin
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-04-2017
Karatteristiċi tal-prodott
(SPC)
28-04-2017
Rapport ta 'Valutazzjoni Pubblika
(PAR)
28-04-2017
Ingredjent attiv:
Dinutuximab
Disponibbli minn:
United Therapeutics Europe Ltd
Kodiċi ATC:
L01FX
INN (Isem Internazzjonali):
dinutuximab
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Neuroblastoma
Indikazzjonijiet terapewtiċi:
Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.
Sommarju tal-prodott:
Revision: 3
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2015-08-14
Fuljett ta 'informazzjoni
24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
UNITUXIN 3.5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
dinutuximab
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
Occasionally a young person who is taking this medicne may be reading
the package leaflet, but usually it
will be a parent/carer. Nevertheless the leaflet will refer to
‘you’ throughout.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Unituxin is and what it is used for
2.
What you need to know before you are given Unituxin
3.
How Unituxin will be given
4.
Possible side effects
5.
How to store Unituxin
6.
Contents of the pack and other information
1.
WHAT UNITUXIN IS AND WHAT IT IS USED FOR
WHAT UNITUXIN IS
Unituxin is a cancer medicine that contains the active substance
dinutuximab. It belongs to a group of
medicines called ‘monoclonal antibodies’. These work like the
antibodies produced naturally by the body.
They help the immune system to target certain cells, such as cancer
cells, by ‘sticking’ to them.
WHAT UNITUXIN IS USED FOR
Unituxin is used to treat ‘high-risk neuroblastoma’ in babies,
children and adolescents aged 12 months to
17 years old.
Neuroblastoma is a type of cancer that grows from abnormal nerve cells
in the body. Some neuroblastomas
are classed as ‘high risk’ if the cancer has spread to various
parts of the body and contains certain types of
cells. High-risk neuroblastomas are more likely to come back again
after treat
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Unituxin 3.5 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of concentrate contains 3.5 mg of dinutuximab.
Each vial contains 17.5 mg of dinutuximab in 5 mL.
Dinutuximab is a chimeric human/mouse monoclonal antibody produced in
a murine myeloma cell line
(Sp2/0) by recombinant DNA technology.
Excipient with known effect:
Each 5 mL vial contains 17.2 mg sodium. For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Unituxin is indicated for the treatment of high-risk neuroblastoma in
patients aged 12 months to 17 years,
who have previously received induction chemotherapy and achieved at
least a partial response, followed by
myeloablative therapy and autologous stem cell transplantation (ASCT).
It is administered in combination
with granulocyte-macrophage colony-stimulating factor (GM-CSF),
interleukin-2 (IL-2), and isotretinoin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unituxin is restricted to hospital-use only and must be administered
under the supervision of a physician
experienced in the use of oncological therapies. It must be
administered by a healthcare professional
prepared to manage severe allergic reactions including anaphylaxis in
an environment where full
resuscitation services are immediately available.
Posology
Unituxin is to be administered by intravenous infusion over five
courses at a daily dose of 17.5 mg/m
2
. It is
administered on Days 4–7 during Courses 1, 3, and 5 (each course
lasting approximately 24 days) and on
Days 8
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