Yescarta

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Axicabtagene ciloleucel

Saadav alates:

Kite Pharma EU B.V.

ATC kood:

L01XX70

INN (Rahvusvaheline Nimetus):

axicabtagene ciloleucel

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

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

Näidustused:

Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.

Toote kokkuvõte:

Revision: 12

Volitamisolek:

Authorised

Loa andmise kuupäev:

2018-08-23

Infovoldik

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
YESCARTA 0.4 – 2
× 10
8 CELLS DISPERSION FOR INFUSION
axicabtagene ciloleucel (CAR+ 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.
-
If you have any further questions, ask your doctor or nurse.
-
Your doctor will give you a Patient Alert Card. Read it carefully and
follow the instructions on
it.
-
Always show the Patient Alert Card to the doctor or nurse when you see
them or if you go to
hospital.
-
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 Yescarta is and what it is used for
2.
What you need to know before you are given Yescarta
3.
How Yescarta is given
4.
Possible side effects
5.
How to store Yescarta
6.
Contents of the pack and other information
1.
WHAT YESCARTA IS AND WHAT IT IS USED FOR
Yescarta is a gene therapy medicine used for treating adults with
aggressive diffuse large B-cell
lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL)
and follicular lymphoma
(FL) affecting your lymph tissue (part of the immune system) that
affects a type of white blood cell
called B lymphocytes and other organs in your body. Too many of these
abnormal white blood cells
accumulate in your tissue and this is the cause of the symptoms you
may have.
The medicine is made specially for you as a single administration of
your own modified white blood
cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN YESCARTA
YOU MUST NOT BE GIVEN YESCARTA:
-
if you are allergic to axicabtagene ciloleucel or any of the other
ingredients of this medicine
(listed in sect

Toote omadused

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
Yescarta 0.4 – 2 × 10
8
cells dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Yescarta (axicabtagene ciloleucel) is a genetically modified
autologous cell-based product containing
T cells transduced
_ex vivo_
using a retroviral vector expressing an anti-CD19 chimeric antigen
receptor
(CAR) comprising a murine anti-CD19 single chain variable fragment
(ScFv) linked to CD28
co-stimulatory domain and CD3-zeta signalling domain.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patient-specific infusion bag of Yescarta contains axicabtagene
ciloleucel at a batch-dependent
concentration of autologous T cells genetically modified to express an
anti-CD19 chimeric antigen
receptor (CAR-positive viable T cells). The medicinal product is
packaged in one infusion bag overall
containing a cell dispersion for infusion of a target dose of 2 × 10
6
anti-CD19 CAR-positive viable
T cells per kg of body weight (range: 1 × 10
6
– 2 × 10
6
cells/kg), with a maximum of
2 × 10
8
anti-CD19 CAR-positive viable T cells suspended in a cryopreservative
solution.
Each infusion bag contains approximately 68 mL of dispersion for
infusion.
Excipients with known effect
Each bag of Yescarta contains 300 mg sodium and 3.4 mL of dimethyl
sulfoxide (DMSO). Yescarta
may contain residual amounts of gentamicin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for infusion.
A clear to opaque, white to red dispersion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Yescarta is indicated for the treatment of adult patients with diffuse
large B-cell lymphoma (DLBCL)
and high-grade B-cell lymphoma (HGBL) that relapses within 12 months
fro