Cellular Therapies

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

tisagenlecleucel, Quantity: 60000000 cells

Dostępny od:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Nazwa):

T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah

Forma farmaceutyczna:

Suspension

Skład:

Excipient Ingredients: N-acetyltryptophan; Albumin; acetate; gluconic acid; sodium; magnesium; potassium; dimethyl sulfoxide; glucose; aluminium; caprylate; dextran 40; furfural; dimethyl sulfone; chloride

Droga podania:

Intravenous Infusion

Klasa:

Class 4

Dziedzina terapeutyczna:

Cellular Therapies

Wskazania:

Kymriah is a genetically modified autologous immunocellular therapy indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah is not indicated for patients with primary central nervous system lymphoma.

Status autoryzacji:

A

Data autoryzacji:

2018-12-19

Ulotka dla pacjenta

Kymriah*
1
KYMRIAH*
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING KYMRIAH?
Kymriah, also known as tisagenlecleucel, is made from some of your own
white blood cells called T-cells. A new gene is put
into the T-cells so that they can target the cancer cells in your
body. Kymriah is used to treat B-cell precursor acute
lymphoblastic leukaemia (B-cell ALL) in children and young adults up
to 25 years, that is refractory in relapse post-transplant,
or in second or later relapse. It is also used to treat relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) after two or
more lines of systemic therapy.
For more information, see Section 1. Why am I given Kymriah? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KYMRIAH?
Do not use if you have ever had an allergic reaction to
tisagenlecleucel 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 Kymriah?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Kymriah 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 KYMRIAH?
•
Your doctor will give you Kymriah by infusion which means it will be
given as a drip through a tube in your vein. This
usually takes less than 1 hour.
More instructions can be found in Section 4. How you will be given
Kymriah? in the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING KYMRIAH?
THINGS YOU SHOULD DO
•
Plan to stay within proximity (2 hours travel) from where you were
treated for at least 4 weeks
after you have been giv

Charakterystyka produktu

1
AUSTRALIAN PI – KYMRIAH
® (TISAGENLECLEUCEL) SUSPENSION
WARNING: CYTOKINE RELEASE SYNDROME
•
Cytokine Release Syndrome (CRS), including fatal or life threatening
reactions, occurred in
patients receiving KYMRIAH. Do not administer KYMRIAH to patients with
active infection
or inflammatory disorders. Treat severe or life threatening CRS with
tocilizumab as per
the CRS management algorithm.
1
NAME OF THE MEDICINE
T Cells – Tisagenlecleucel, cryopreserved – T - Kymriah
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tisagenlecleucel: Autologous T-cells genetically modified _ex vivo_
using a lentiviral vector encoding an
anti-CD19 chimeric antigen receptor (CAR).
1 or more infusion bags containing a total of 1.2 x 10
6
to 6.0 x 10
8
CAR-positive viable T cells in 10 to
50 mL. The quantitative information regarding total cells in the
product is presented in the Certificate
of Analysis.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Cell suspension.
Appearance: colourless to slightly yellow suspension of cells.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Kymriah is a genetically modified autologous immunocellular therapy
indicated for:
•
the treatment of paediatric and young adult patients up to 25 years of
age with B-cell
precursor acute lymphoblastic leukaemia (ALL) that is refractory, in
relapse post-transplant, or in
second or later relapse.
•
the treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma
(DLBCL) after two or more lines of systemic therapy. Kymriah is not
indicated for patients with primary
central nervous system lymphoma.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Manufacture and release of Kymriah usually takes about 3 to 4 weeks.
Kymriah must be administered in a treatment centre that has been
qualified by the sponsor. Therapy
should be initiated under the direction of and supervised by a
healthcare professional experienced in
2
the
treatment of
haematological
malignancies and
trained
for
Kymriah
administration
a