Cellular Therapies

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

axicabtagene ciloleucel, Quantity: 1000000 cells/kg

Disponibil de la:

Gilead Sciences Pty Ltd

INN (nume internaţional):

T Cells - Axicabtagene ciloleucel, cryopreserved - T - Yescarta

Forma farmaceutică:

Injection, intravenous infusion

Compoziție:

Excipient Ingredients: Albumin; sodium chloride; dimethyl sulfoxide

Calea de administrare:

Intravenous Infusion

Clasă:

Class 4

Zonă Terapeutică:

Cellular Therapies

Indicații terapeutice:

YESCARTA is a genetically modified autologous immunocellular therapy for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

Statutul autorizaţiei:

A

Data de autorizare:

2020-02-11

Prospect

YESCARTA
1
YESCARTA
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I GIVEN YESCARTA?
YESCARTA also known as axicabtagene ciloleucel is a type of medicine
called a “genetically modified cell therapy”. YESCARTA is
used to treat adults with aggressive large B‐cell lymphoma (LBCL)
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.
For more information, see Section 1. Why am I given YESCARTA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE YESCARTA?
Do not use if you have ever had an allergic reaction to axicabtagene
ciloleucel or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given YESCARTA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with YESCARTA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN YESCARTA?
•
YESCARTA is made specially for you as a single administration of your
own modified white blood cells.
•
Your doctor will give you YESCARTA by a drip (_infusion_) into a vein
(_intravenously_).
More instructions can be found in Section 4. How am I given YESCARTA?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING YESCARTA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you have been
given YESCARTA.
•
Plan to stay within proximity (i.e. within 2 hours) of the hospital
where you will be treated for at least
4 weeks after you hav

Caracteristicilor produsului

YESCARTA
®
Product Information v5.0 – (09 December 2022)
Page 1
AUSTRALIAN PRODUCT INFORMATION
YESCARTA
® (AXICABTAGENE CILOLEUCEL) SUSPENSION FOR INTRAVENOUS INFUSION
WARNING: CYTOKINE RELEASE SYNDROME
•
Cytokine Release Syndrome (CRS), including fatal or life-threatening
reactions,
occurred in patients receiving YESCARTA. Do not administer YESCARTA to
patients with active infection or inflammatory disorders. Treat severe
or life-
threatening CRS with tocilizumab or tocilizumab and corticosteroids.
1. NAME OF THE MEDICINE
YESCARTA (axicabtagene ciloleucel), 1 x 10
6
- 2.4 x 10
6
anti-CD19 CAR T cells/kg suspension
for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

GENERAL DESCRIPTION
YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically
modified autologous T
cell immunotherapy. To prepare YESCARTA, patient’s own T cells are
harvested and
genetically modified
_ex vivo_
by retroviral transduction to express a chimeric antigen receptor
(CAR) comprising a murine anti-CD19 single chain variable fragment
(scFv) linked to CD28
and CD3 zeta co-stimulatory domains. The anti-CD19 CAR-positive viable
T cells are expanded
and infused back into the patient, where they can recognise and
eliminate CD19 expressing
target cells.
YESCARTA is prepared from the patient’s peripheral blood mononuclear
cells, which are
obtained via a standard leukapheresis procedure. The mononuclear cells
are enriched for T cells
and activated with anti-CD3 antibody in the presence of IL-2, then
transduced with the
replication incompetent retroviral vector containing the anti-CD19 CAR
transgene. The
transduced T cells are expanded in cell culture, washed, formulated
into a suspension, and
cryopreserved. The product must pass a sterility test before release
for shipping as a frozen
suspension in a patient-specific infusion bag. The product is thawed
prior to infusion.
In addition to T cells, YESCARTA may contain NK and NK-T cells. The
formulation contains
5% dimethylsulfoxide (DMSO) and 2.5% albumin (human).

QUALITA