YESCARTA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AXICABTAGENE CILOLEUCEL

Available from:

GILEAD SCIENCES ISRAEL LTD

Pharmaceutical form:

DISPERSION FOR INFUSION

Composition:

AXICABTAGENE CILOLEUCEL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

KITE PHARMA, INC., USA

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 from completion of, or is refractory to, first-line chemoimmunotherapy.YESCARTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Limitation of Use :YESCARTA is not indicated for the treatment of patients with primary or secondary central nervous system lymphoma.Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy

Authorization date:

2019-08-19

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS)
REGULATIONS
- 1986
This medicine is to be supplied by doctor’s prescription only
YESCARTA
®
0.4
– 2 × 10
8 CELLS DISPERSION FOR INFUSION
ACTIVE INGREDIENTS:
The active substance is axicabtagene ciloleucel. Each patient-specific
single infusion bag contains a
dispersion of genetically modified anti-CD19 CAR (chimeric antigen
receptor) T cells in
approximately 68 mL for a target dose of 2 x 10
6
anti-CD19 CAR-positive viable T cells/kg.
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?
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 diffuse large B-cell
lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma
(PMBCL), after two or more
lines of systemic therapy.
Limitation of Use: Yescarta is not indicated for the treatment of
patients with primary or secondary
central nervous system lymphoma.
Yescarta is indicated for the treatment of adult patients with
relapsed or refractory follicular
lymphoma (FL) after two or more lines of systemic therapy.
THERAPEUTIC GROUP: Other antineoplastic agents
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) tha

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Yescarta
®
0.4
–
2 × 10
8
cells dispersion for intravenous 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 intravenous infusion.
PATIENT SAFETY INFORMATION CARD
The marketing of Yescarta is subject to a risk management plan (RMP)
including a patient safety
information card.
The
patient safety information card,
emphasises important safety information
that the patient should be aware of before and during treatment.
Please explain to the patient the need
to review the card before starting treatment.
PRESCRIBER GUIDE
This product is marketed with prescriber guide providing important
safety information. Please ensure
you are familiar with this material as it contains