Breyanzi

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells)

Saatavilla:

Bristol-Myers Squibb Pharma EEIG

ATC-koodi:

L01

INN (Kansainvälinen yleisnimi):

lisocabtagene maraleucel

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms

Käyttöaiheet:

Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Tuoteyhteenveto:

Revision: 2

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-04-04

Pakkausseloste

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BREYANZI 1.1-70 × 10
6 CELLS/ML / 1.1-70 × 10
6 CELLS/ML DISPERSION FOR INFUSION
lisocabtagene maraleucel (chimeric antigen receptor [CAR] positive
viable T cells)
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 ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
Your doctor will give you a Patient card. Read it carefully and follow
the instructions on it.
•
Always show the Patient card to the doctor or nurse when you see them
or if you go into
hospital.
•
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 Breyanzi is and what it is used for
2.
What you need to know before you are given Breyanzi
3.
How Breyanzi is given
4.
Possible side effects
5.
How to store Breyanzi
6.
Contents of the pack and other information
1.
WHAT BREYANZI IS AND WHAT IT IS USED FOR
WHAT BREYANZI IS
Breyanzi contains the active substance lisocabtagene maraleucel, a
type of treatment called
‘genetically modified cell therapy’.
Breyanzi is made from your own white blood cells.This involves taking
some of your blood and
separating out the white blood cells and sending the white blood cells
to a laboratory so that they can
be modified to make Breyanzi.
WHAT BREYANZI IS USED FOR
Breyanzi is used to treat adults with a type of blood cancer called
lymphoma which affects your lymph
tissue and causes white blood cells to grow out of control. Breyanzi
is used for:
•
diffuse large B-cell lymphoma
•
high-grade B-cell lymphoma
•
primary mediastinal large B-cell lymphoma
•
follicu

Valmisteyhteenveto

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
Breyanzi 1.1-70 × 10
6
cells/mL / 1.1-70 × 10
6
cells/mL dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Breyanzi (lisocabtagene maraleucel) is a CD19-directed genetically
modified autologous cell-based
product consisting of purified CD8+ and CD4+ T cells, in a defined
composition, that have been
separately transduced
_ex vivo_
using a replication incompetent lentiviral vector expressing an anti-
CD19 chimeric antigen receptor (CAR) comprising a single chain
variable fragment (scFv) binding
domain derived from a murine CD19-specific monoclonal antibody (mAb;
FMC63) and a portion of
the 4-1BB co-stimulatory endodomain and CD3 zeta (ζ) chain signalling
domains and a nonfunctional
truncated epidermal growth factor receptor (EGFRt).
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Breyanzi contains CAR-positive viable T cells, consisting of a defined
composition of CD8+ and
CD4+ cell components:
CD8+ cell component
Each vial contains lisocabtagene maraleucel at a batch-specific
concentration of autologous T cells
genetically modified to express anti-CD19 chimeric antigen receptor
(CAR-positive viable T cells).
The medicinal product is packaged in one or more vials containing a
cell dispersion of 5.1-322 × 10
6
CAR-positive viable T cells (1.1-70 × 10
6
CAR-positive viable T cells/mL) suspended in a
cryopreservative solution.
Each vial contains 4.6 mL of CD8+ cell component.
CD4+ cell component
Each vial contains lisocabtagene maraleucel at a batch-specific
concentration of autologous T cells
genetically modified to express anti-CD19 chimeric antigen receptor
(CAR-positive viable T cells).
The medicinal product is packaged in one or more vials c