Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

Dinutuximab beta

Dostupné z:

Recordati Netherlands B.V.

ATC kód:

L01FX

INN (Medzinárodný Name):

dinutuximab beta

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

Neuroblastoma

Terapeutické indikácie:

Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin 2 (IL 2).

Prehľad produktov:

Revision: 16

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-05-08

Príbalový leták

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
QARZIBA 4.5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
dinutuximab beta
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.
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 Qarziba is and what it is used for
2.
What you need to know before you use Qarziba
3.
How to use Qarziba
4.
Possible side effects
5.
How to store Qarziba
6.
Contents of the pack and other information
1.
WHAT QARZIBA IS AND WHAT IT IS USED FOR
Qarziba contains dinutuximab beta, which belongs to a group of
medicines called ‘monoclonal
antibodies’. These are proteins, which specifically recognise and
bind to other unique proteins in the
body. Dinutuximab beta binds to the molecule known as
disialoganglioside 2 (GD2), which is present
on cancer cells, and this activates the body’s immune system,
causing it to attack the cancer cells.
Qarziba is
USED TO TREAT NEUROBLASTOMA
that has a high risk of coming back after a series of
treatments, which include a stem cell transplantation for rebuilding
the immune system. It is also used
to treat neuroblastoma that has come back (relapsed) or could not be
completely treated with previous
therapies.
Prior to the treatment of relapsed neuroblastoma, your treating
physician will stabilise any actively
progressing disease by other suitable measures.
Your doctor will further decide whether the co-administration of a
second medicine, interleukin-2, is
necessary for the treatment of your cancer.
Neuroblastoma is a type of c

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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
Qarziba 4.5 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of concentrate contains 4.5 mg dinutuximab beta.
Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody
produced in a mammalian
cell line (CHO) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Colourless to slightly yellow liquid
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Qarziba is indicated for the treatment of high-risk neuroblastoma in
patients aged 12 months and
above, who have previously received induction chemotherapy and
achieved at least a partial response,
followed by myeloablative therapy and stem cell transplantation, as
well as patients with history of
relapsed or refractory neuroblastoma, with or without residual
disease. Prior to the treatment of
relapsed neuroblastoma, any actively progressing disease should be
stabilised by other suitable
measures.
In patients with a history of relapsed/refractory disease and in
patients who have not achieved a
complete response after first line therapy, Qarziba should be combined
with interleukin-2 (IL-2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Qarziba 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
Treatment with Qarziba consists of 5 consecutive courses, each c