Abecma

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

idecabtagene vicleucel

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

L01

INN (International Name):

idecabtagene vicleucel

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Therapeutic indications:

Abecma 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: 6

Authorization status:

Authorised

Authorization date:

2021-08-18

Patient Information leaflet

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABECMA 260 - 500 X 10
6
CELLS DISPERSION FOR INFUSION
idecabtagene vicleucel (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 ARE GIVEN 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.

Your doctor will give you a Patient Alert Card. Read it carefully and
follow the instructions on
it.

Always show the Patient Alert Card to the doctor or nurse when you see
them or if you go to
hospital.

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.
WHAT IS IN THIS LEAFLET
1.
What Abecma is and what it is used for
2.
What you need to know before you are given Abecma
3.
How Abecma is given
4.
Possible side effects
5.
How to store Abecma
6.
Contents of the pack and other information
1.
WHAT ABECMA IS AND WHAT IT IS USED FOR
WHAT ABECMA IS
Abecma is a type of medicine called a ‘genetically modified cell
therapy’. The active substance in the
medicine is idecabtagene vicleucel, which is made from your own white
blood cells, called T cells.
WHAT ABECMA IS USED FOR
Abecma is used to treat adults with multiple myeloma, which is a
cancer of the bone marrow.
It is given when previous treatments for your cancer have not worked
or the cancer has come back
.
HOW ABECMA WORKS
The white blood cells are taken from your blood and are genetically
modified so that they can target
the myeloma cells in your body.
When Abecma is infused into your blood, the modified white blood cells
will kill the myeloma cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ABECMA
_ _
YOU MUST NOT BE GIVEN ABECMA


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
Abecma 260 - 500 x 10
6
cells dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Abecma (idecabtagene vicleucel) is a genetically modified autologous
cell-based product containing
T cells transduced
_ex-vivo _
using a replication incompetent lentiviral vector (LVV) encoding a
chimeric
antigen receptor (CAR) that recognises B-cell maturation antigen
(BCMA), comprising a murine-
derived, anti-human BCMA single chain variable fragment (scFv) linked
to a 4-1BB costimulatory
domain and a CD3-zeta signalling domain.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patient-specific infusion bag of Abecma contains idecabtagene
vicleucel at a batch-dependent
concentration of autologous T cells genetically modified to express an
anti-BCMA chimeric antigen
receptor (CAR-positive viable T cells). The medicinal product is
packaged in one or more infusion
bags overall containing a cell dispersion of 260 to 500 x 10
6
CAR-positive viable T cells suspended in
a cryopreservative solution.
Each infusion bag contains 10-30 mL, 30-70 mL or 55-100 mL of
dispersion for infusion.
The cellular composition and the final cell number varies between
individual patient batches. In
addition to T cells, natural killer (NK) cells may be present. The
quantitative information of medicinal
product, including the number of infusion bag(s) to be administered,
is presented in the release for
infusion certificate (RfIC) located inside the lid of the cryoshipper
used for transport.
Excipients with known effect
This medicinal product contains 5% dimethyl sulfoxide (DMSO), up to
752 mg sodium and up to
274 mg potassium per dose.
For the full list of excipients, see section 6.1.
3.
PHA