Kymriah

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

tisagenlecleucel

Tillgänglig från:

Novartis Europharm Limited

ATC-kod:

L01XL04

INN (International namn):

tisagenlecleucel

Terapeutisk grupp:

Other antineoplastic agents

Terapiområde:

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse

Terapeutiska indikationer:

Kymriah is indicated for the treatment of:• Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse.• Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.• Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Produktsammanfattning:

Revision: 14

Bemyndigande status:

Authorised

Tillstånd datum:

2018-08-22

Bipacksedel

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
Kymriah 1.2 × 10
6
– 6 × 10
8
cells dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Kymriah (tisagenlecleucel) is a genetically modified autologous
cell-based product containing T cells
transduced
_ex vivo_
using a lentiviral vector expressing an anti-CD19 chimeric antigen
receptor (CAR)
comprising a murine anti-CD19 single chain variable fragment (scFv)
linked via a human CD8 hinge
and transmembrane region to an intracellular signalling chain of human
4-1BB (CD137)
co-stimulatory domain and CD3-zeta signalling domain.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patient-specific infusion bag of Kymriah contains
tisagenlecleucel 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 or more infusion
bags overall containing a cell dispersion of 1.2 × 10
6
to 6 × 10
8
CAR-positive viable T cells in a
cryopreservative- solution.
The cellular composition and the final cell number varies between
individual patient batches. In
addition to T cells, natural killer (NK) cells may be present.
Each infusion bag contains 10–30 mL or 30–50 mL of cell
dispersion.
The quantitative information of medicinal product, including the
number of infusion bags (see
section 6) to be administered, is presented on the batch specific
documentation accompanying the
medicinal product for treatment.
Excipients with known effect
This medicinal product contains 2.43 mg sodium per mL and 24.3 to
121.5 mg sodium per dose.
Each bag contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide
(DMSO) per mL.
For the full list

Produktens egenskaper

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
Kymriah 1.2 × 10
6
– 6 × 10
8
cells dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Kymriah (tisagenlecleucel) is a genetically modified autologous
cell-based product containing T cells
transduced
_ex vivo_
using a lentiviral vector expressing an anti-CD19 chimeric antigen
receptor (CAR)
comprising a murine anti-CD19 single chain variable fragment (scFv)
linked via a human CD8 hinge
and transmembrane region to an intracellular signalling chain of human
4-1BB (CD137)
co-stimulatory domain and CD3-zeta signalling domain.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patient-specific infusion bag of Kymriah contains
tisagenlecleucel 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 or more infusion
bags overall containing a cell dispersion of 1.2 × 10
6
to 6 × 10
8
CAR-positive viable T cells in a
cryopreservative- solution.
The cellular composition and the final cell number varies between
individual patient batches. In
addition to T cells, natural killer (NK) cells may be present.
Each infusion bag contains 10–30 mL or 30–50 mL of cell
dispersion.
The quantitative information of medicinal product, including the
number of infusion bags (see
section 6) to be administered, is presented on the batch specific
documentation accompanying the
medicinal product for treatment.
Excipients with known effect
This medicinal product contains 2.43 mg sodium per mL and 24.3 to
121.5 mg sodium per dose.
Each bag contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide
(DMSO) per mL.
For the full list