Cellular Therapies

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

ciltacabtagene autoleucel, Quantity: 500000 cells/kg

Tilgængelig fra:

Janssen-Cilag Pty Ltd

INN (International Name):

T cells-Ciltacabtagene autoleucel, cryopreserved-T-CARVYKTI

Lægemiddelform:

Injection, intravenous infusion

Sammensætning:

Excipient Ingredients: dimethyl sulfoxide

Indgivelsesvej:

Intravenous Infusion

Klasse:

Class 4

Terapeutisk område:

Cellular Therapies

Terapeutiske indikationer:

CARVYKTI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.

Autorisation status:

A

Autorisation dato:

2023-06-06

Indlægsseddel

CARVYKTI
1
CARVYKTI™
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this gene therapy product, speak to your doctor or
pharmacist.

This gene therapy product is new. Please report side effects. See the
full CMI for further details.
1.
WHY AM I RECEIVING CARVYKTI?
CARVYKTI consists of your own white blood cells that have been
genetically modified.
CARVYKTI is used to treat patients with cancer of the bone marrow
called multiple myeloma. It is given when at least three other
kinds of treatment have not worked.
CARVYKTI is given to adults aged 18 years and older.
For more information, see Section 1. Why am I receiving CARVYKTI? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE CARVYKTI?
•
Do not receive if you have ever had an allergic reaction to any of the
ingredients listed at the end of the full 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.
CARVYKTI should not be given to children under 18 years.
For more information, see Section 2. What should I know before I
receive CARVYKTI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CARVYKTI and affect how it works.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I RECEIVE CARVYKTI?
Your doctor or nurse will give CARVYKTI to you at a qualified
treatment centre. You will receive one infusion.
More information can be found in Section 4. How do I receive CARVYKTI?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING CARVYKTI?
THINGS YOU
SHOULD DO
•
FAMILIARISE YOURSELF WITH THE SIDE EFFECTS WHICH MAY REQUIRE URGENT
MEDICAL ATTENTION.
•
CALL YOUR DOCTOR STRAIGHT AWAY IF YOU: Notice signs of severe allergic
reaction or any other side effect
requiring urgent medical attention.
•
Plan to stay near the hospital where you were treated for at least 4
weeks after you have CARVYKTI.

Produktets egenskaber

5.220728
1
CARVYKTI (230606) API
This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse events at
https://www.tga.gov.au/reporting-problems.
CARVYKTI
TM
CILTACABTAGENE AUTOLEUCEL
A
USTRALIAN
P
RODUCT
I
NFORMATION
1. NAME OF THE MEDICINE
ciltacabtagene autoleucel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CARVYKTI ciltacabtagene autoleucel suspension for intravenous
infusion.
A single dose of CARVYKTI is 0.5-1.0

10
6
CAR-positive viable T-cells per kg body weight up to
a maximum of 1

10
8
CAR-positive viable T-cells suspended in a patient-specific infusion
bag (see
SECTION 4.2 Dosage and Method of Administration).
For a full list of excipients, see SECTION 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Suspension for intravenous infusion
CARVYKTI (ciltacabtagene autoleucel) is a B cell maturation antigen
(BCMA)-directed genetically
modified autologous T cell immunotherapy. CARVYKTI 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 genetically modified
_ex vivo_ by transduction with a
replication incompetent lentiviral vector to express a chimeric
antigen receptor (CAR) comprising
an anti-BCMA targeting domain, which consists of two single domain
antibodies linked to 4-1BB
costimulatory domain and CD3-zeta signalling domains.
The transduced anti-BCMA CAR 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 and then infused
▼

WARNING: CYTOKINE RELEASE SYNDROME
• Cytokine Release Syndrome (CRS), including fatal or
life-threatening
reactions, occurred in patients receiving CARVYKTI. Do not administer
CARVYKTI to patients with active infection