Tecartus

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel)

Disponible depuis:

Kite Pharma EU B.V.

Code ATC:

L01X

DCI (Dénomination commune internationale):

Brexucabtagene autoleucel

Groupe thérapeutique:

Antineoplastic agents

Domaine thérapeutique:

Lymphoma, Mantle-Cell

indications thérapeutiques:

Mantle cell lymphomaTecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.Acute lymphoblastic leukaemiaTecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

Descriptif du produit:

Revision: 5

Statut de autorisation:

Authorised

Date de l'autorisation:

2020-12-14

Notice patient

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TECARTUS 0.4 – 2 × 10
8 CELLS DISPERSION FOR INFUSION
brexucabtagene autoleucel (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.
–
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 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 Tecartus is and what it is used for
2.
What you need to know before you are given Tecartus
3.
How Tecartus is given
4.
Possible side effects
5.
How to store Tecartus
6.
Contents of the pack and other information
1.
WHAT TECARTUS IS AND WHAT IT IS USED FOR
Tecartus is a gene therapy medicine used for treating mantle cell
lymphoma and B-cell acute
lymphoblastic leukaemia in adults. It is used when other medicines
have stopped working for you
(relapsed or refractory disease). The medicine is made specially for
you from your own white blood
cells that have been modified and is known as brexucabtagene
autoleucel.
Mantle cell lymphoma and B-cell acute lymphoblastic leukaemia are
cancers of a part of the immune
system (the body’s defences). They affect a type of white blood cell
called B-lymphocytes. In both
mantle cell lymphoma and B-cell acute lymphoblastic leukaemia,
B-lymphocytes grow in an
uncontrolled way and build up in the lymph tissue, bone marrow or
blood.
HOW TECARTUS WORKS
The white blood cells

Résumé des caractéristiques du produit

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
Tecartus 0.4 – 2 × 10
8
cells dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Tecartus (brexucabtagene autoleucel) 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
Mantle cell lymphoma
Each patient-specific infusion bag of Tecartus contains brexucabtagene
autoleucel 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/kg 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 Cryostor CS10
solution.
Each infusion bag contains approximately 68 mL of dispersion for
infusion.
Acute lymphoblastic leukaemia
Each patient-specific infusion bag of Tecartus contains brexucabtagene
autoleucel 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
1 × 10
6
anti CD19 CAR positive
viable T cells/kg body weight, with a maximum of 1 × 10
8
anti CD19 CAR positive viable