Carvykti

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ciltacabtagene autoleucel

Available from:

Janssen-Cilag International NV

ATC code:

L01XL05

INN (International Name):

ciltacabtagene autoleucel

Therapeutic area:

Multiple Myeloma

Therapeutic indications:

Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2022-05-25

Patient Information leaflet

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARVYKTI 3.2 × 10
6
– 1 × 10
8
CELLS DISPERSION FOR INFUSION
ciltacabtagene autoleucel (CAR+ viable T cells)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.

The doctor or nurse will give you a Patient Alert Card which contains
important safety
information about the treatment with CARVYKTI. Read it carefully and
follow the instructions
on it.

Carry the Patient Alert Card with you at all times and always show it
to any doctor or nurse who
sees you or if you go to the hospital.
WHAT IS IN THIS LEAFLET
1.
What CARVYKTI is and what it is used for
2.
What you need to know before you are given CARVYKTI
3.
How CARVYKTI is given
4.
Possible side effects
5.
How to store CARVYKTI
6.
Contents of the pack and other information
1.
WHAT CARVYKTI IS AND WHAT IT IS USED FOR

CARVYKTI is a type of medicine called a “genetically modified cell
therapy” which is made
especially for you from your own white blood cells, called T cells.

CARVYKTI is used to treat adult patients with cancer of the bone
marrow called multiple
myeloma. It is given when at least three other kinds of treatment have
not worked.
HOW CARVYKTI WORKS

The white blood cells taken from your blood are modified in the
laboratory to insert a gene that
allows them to make a protein called chimeric antigen receptor (CAR).

The CAR can attach to a specific protein on the surface of myeloma
cells allowing your w

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
CARVYKTI 3.2 × 10
6
– 1 × 10
8
cells dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
CARVYKTI (ciltacabtagene autoleucel) is a genetically modified
autologous cell-based product,
containing T cells transduced_ ex vivo_ using a replication
incompetent lentiviral vector encoding an
anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR),
comprising two single
domain antibodies linked to a 4-1BB costimulatory domain and a
CD3-zeta signaling domain.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patient-specific infusion bag of CARVYKTI contains ciltacabtagene
autoleucel at a
batch-dependent concentration of autologous T cells genetically
modified to express an anti-BCMA
chimeric antigen receptor (CAR-positive viable T cells) (see section
4.2). The medicinal product is
packaged in one infusion bag containing a cell dispersion for infusion
of 3.2 × 10
6
to 1 × 10
8
CAR-
positive viable T cells suspended in a cryopreservative solution.
An infusion bag contains 30 mL or 70 mL of dispersion for infusion.
The cellular composition and the final cell number is dependent on
patient body weight and varies
between individual patient batches. In addition to T cells, Natural
Killer (NK) cells may be present.
The quantitative information of the medicinal product including the
total viable cell concentration,
volume of dispersion and total number of CAR+ cells per bag and
supplied dose is presented in the
Lot Information Sheet included with the cryo cassette used for
transport of CARVYKTI.
Excipient(s) with known effect
Each dose of CARVYKTI contains 0.05 mL of dimethyl sulfoxide (DMSO)
per mL and residual
kanamycin (see section 4.4).
F