Blincyto

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

blinatumomab

Διαθέσιμο από:

Amgen Europe B.V.

Φαρμακολογική κατηγορία (ATC):

L01FX07

INN (Διεθνής Όνομα):

blinatumomab

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Θεραπευτικές ενδείξεις:

Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy (see section 4.2).,

Περίληψη προϊόντος:

Revision: 18

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-11-23

Φύλλο οδηγιών χρήσης

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BLINCYTO 38.5 MICROGRAMS POWDER FOR CONCENTRATE AND SOLUTION FOR
SOLUTION FOR INFUSION
blinatumomab
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.
-
Your doctor will also give you the following educational materials:
-
Educational Brochure for Patients and Caregivers, which contains
important safety
information that you need to be aware of before you are given BLINCYTO
and during
treatment with BLINCYTO.
-
Patient Card with contact details of your medical team and information
when to call your
doctor or nurse. Keep this Patient Card with you, at all times.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BLINCYTO is and what it is used for
2.
What you need to know before you use BLINCYTO
3.
How to use BLINCYTO
4.
Possible side effects
5.
How to store BLINCYTO
6.
Contents of the pack and other information
1.
WHAT BLINCYTO IS AND WHAT IT IS USED FOR
The active ingredient in BLINCYTO is blinatumomab. This belongs to a
group of medicines called
antineoplastic agents which target cancer cells.
BLINCYTO is used to treat adults with acute lymphoblastic leukaemia.
Acute lymphoblastic
leukaemia is a cancer of the blood in which a particular kind of white
blood cell called
“B-lymphocyte” is growing out of control. This medicine works by
enabling your immune system to
attack and destroy these abnormal white blood cancer cells. BLINCYTO
is used when acute
lymphoblastic leukaemia has come back

Αρχείο Π.Χ.Π.

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
BLINCYTO 38.5 micrograms powder for concentrate and solution for
solution for infusion.
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 38.5 micrograms blinatumomab.
Reconstitution with water for injections results in a final
blinatumomab concentration of
12.5 micrograms/mL.
Blinatumomab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate and solution for solution for infusion.
BLINCYTO powder (powder for concentrate): White to off-white powder.
Solution (stabiliser): Colourless-to-slightly yellow, clear solution
with a pH of 7.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BLINCYTO is indicated as monotherapy for the treatment of adults with
CD19 positive relapsed or
refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
Patients with Philadelphia
chromosome-positive B-cell precursor ALL should have failed treatment
with at least 2 tyrosine
kinase inhibitors (TKIs) and have no alternative treatment options.
BLINCYTO is indicated as monotherapy for the treatment of adults with
Philadelphia chromosome-
negative CD19 positive B-cell precursor ALL in first or second
complete remission with minimal
residual disease (MRD) greater than or equal to 0.1%.
BLINCYTO is indicated as monotherapy for the treatment of paediatric
patients aged 1 year or older
with Philadelphia chromosome-negative CD19 positive B-cell precursor
ALL which is refractory or in
relapse after receiving at least two prior therapies or in relapse
after receiving prior allogeneic
haematopoietic stem cell transplantation.
BLINCYTO is indicated as monotherapy fo