TECARTUS

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

ANTI-CD19 CAR T CELLS

Dostępny od:

GILEAD SCIENCES ISRAEL LTD

Forma farmaceutyczna:

DISPERSION FOR INFUSION

Skład:

ANTI-CD19 CAR T CELLS

Droga podania:

I.V

Typ recepty:

Required

Wyprodukowano przez:

KITE PHARMA, INC., USA

Wskazania:

Acute Lymphoblastic Leukaemia Tecartus is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).Mantle Cell Lymphoma Tecartus 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 unless ineligible to BTK inhibitor •Limitation of Use : TECARTUS is not indicated for the treatment of patients with active central nervous system lymphoma

Data autoryzacji:

2021-11-03

Ulotka dla pacjenta

1
PATIENT LEAFLET
IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS) REGULATIONS
- 1986
This medicine is to be supplied by doctor’s prescription only
TECARTUS
®
0.4
– 2 × 10
8 CELLS DISPERSION FOR INFUSION
ACTIVE INGREDIENTS:
The active substance is brexucabtagene autoleucel (0.4
–
2 × 10
8
cells dispersion for infusion). Each
patient-specific single infusion bag contains a dispersion of
anti-CD19 CAR (chimeric antigen
receptor)-positive viable T cells in approximately 68 mL for a target
dose of 2 x 10
6
anti-CD19 CAR-
positive viable T cells/kg for mantle cell lymphoma patients and a
target dose of
1 × 10
6
anti-CD19 CAR-positive viable T cells/kg for B-cell acute
lymphoblastic leukaemia patients.
Inactive and allergenic substances: see section 6
_“Additional information_
”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. This leaflet contains
essential information about this medicine. If you have any further
questions, ask your healthcare
provider team. This medicine has been prescribed for you only. Do not
pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Tecartus 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 unless ineligible to BTK inhibitor.
Limitation of use: Tecartus is not indicated for the treatment of
patients with active central nervous
system lymphoma.
Tecartus is indicated for the treatment of adult patients with
relapsed or refractory B-cell precursor
acute lymphoblastic leukaemia (ALL).
THERAPEUTIC GROUP: Other antineoplastic agents
Mantle cell lymphoma and B-cell acute lymphoblastic leukaemia are
cancers of a part of the immune
system (the body’s defences).
They affects 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
uncontroll

Charakterystyka produktu

1
1.
NAME OF THE MEDICINAL PRODUCT
Tecartus
®
0.4
–
2 × 10
8
cells dispersion for intravenous 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 T cells
suspended in a Cryostor CS10 solution.
Each infusion bag contains approximately 68 mL of dispersion for
infusion.
Excipient(s) with known effect
This medicinal product contains 300 mg sodium.
Each dose contains 0.05 mL of dimethyl sulfoxide (DMSO) per mL of
Tecartus.
For the f