Talvey

Land: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

talquetamab

Fáanlegur frá:

Janssen-Cilag International N.V.

ATC númer:

L01FX29

INN (Alþjóðlegt nafn):

talquetamab

Meðferðarhópur:

Antineoplastic agents

Lækningarsvæði:

Multiple Myeloma

Ábendingar:

Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 antibody and have demonstrated disease progression on the last therapy.,

Vörulýsing:

Revision: 1

Leyfisstaða:

Authorised

Leyfisdagur:

2023-08-21

Upplýsingar fylgiseðill

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TALVEY 2 MG/ML SOLUTION FOR INJECTION
TALVEY 40 MG/ML SOLUTION FOR INJECTION
talquetamab
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.
-
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 Talvey is and what it is used for
2.
What you need to know before you are given Talvey
3.
How Talvey is given
4.
Possible side effects
5.
How to store Talvey
6.
Contents of the pack and other information
1.
WHAT TALVEY IS AND WHAT IT IS USED FOR
Talvey is a cancer medicine that contains the active substance
talquetamab. Talquetamab is an
antibody, a type of protein that recognises and attaches to specific
targets in your body. It has been
designed to attach to the protien GPRC5D (G Protein-coupled receptor
family C group 5 member D),
which is found on multiple myeloma cancer cells, and to CD3, a protein
on T cells (a type of white
blood cell). T cells are a part of the body’s natural defences and
help protect the body from infection.
They can also destroy cancer cells. When this medicine attaches to
these cells, it brings the cancer
cells and T cells together. This encourages the T cells to destroy the
multiple myeloma cancer cells.
Talvey is used to treat adults with multiple myeloma, a cancer of the
bone marrow.
It is used when patients have had at least three other types of
treatment that have not worked or have
stopped working.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TALVEY
YOU MUST NOT BE GIVEN TALVEY

if you are

Vara einkenni

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
TALVEY 2 mg/mL solution for injection
TALVEY 40 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TALVEY 2 mg/mL solution for injection
One 1.5 mL vial contains 3 mg of talquetamab (2 mg/mL).
TALVEY 40 mg/mL solution for injection
One 1 mL vial contains 40 mg of talquetamab (40 mg/mL).
Talquetamab is a humanised immunoglobulin g4-proline, alanine, alanine
(IgG4-PAA) bispecific
antibody directed against G protein-coupled receptor family C group 5
member D (GPRC5D) and the
CD3 receptors, produced in Chinese hamster ovary cells by recombinant
DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is colourless to light yellow, with pH of 5.2 and
osmolality of 287-290 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TALVEY is indicated as monotherapy for the treatment of adult patients
with relapsed and refractory
multiple myeloma, who have received at least 3 prior therapies,
including an immunomodulatory
agent, a proteasome inhibitor, and an anti-CD38 antibody and have
demonstrated disease progression
on the last therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with TALVEY should be initiated and supervised by physicians
experienced in the
treatment of multiple myeloma.
TALVEY should be administered by a healthcare professional with
adequately-trained medical
personnel and appropriate medical equipment to manage severe
reactions, including cytokine release
syndrome (CRS) and neurologic toxicity, including immune effector
cell-associated neurotoxicity
syndrome (ICANS).
Posology
Pre-treatment medicinal products should be administered prior to each
dose of TALVE