Blenrep

Država: Evropska unija

Jezik: angleščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

belantamab mafodotin

Dostopno od:

GlaxoSmithKline (Ireland) Limited

Koda artikla:

L01XC39

INN (mednarodno ime):

belantamab mafodotin

Terapevtska skupina:

Antineoplastic agents

Terapevtsko območje:

Multiple Myeloma

Terapevtske indikacije:

Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Povzetek izdelek:

Revision: 7

Status dovoljenje:

Authorised

Datum dovoljenje:

2020-08-25

Navodilo za uporabo

26
B. PACKAGE LEAFLET
Medicinal product no longer authorised
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BLENREP_ _100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
belantamab mafodotin
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 BLENREP is and what it is used for
2.
What you need to know before you are given BLENREP
3.
How BLENREP is given
4.
Possible side effects
5.
How to store BLENREP
6.
Contents of the pack and other information
1.
WHAT BLENREP IS AND WHAT IT IS USED FOR
BLENREP contains the active substance
BELANTAMAB MAFODOTIN,
a
_monoclonal antibody _
connected to
an anticancer substance that can kill multiple myeloma cells. The
monoclonal antibody is a protein
designed to find the multiple myeloma cancer cells in your body and
bind to them.
Once attached to the cancer cells, the anticancer substance is
released and kills the cancer cells.
BLENREP is used to treat adults who have cancer of the bone marrow
called multiple myeloma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BLENREP
_ _
DO NOT RECEIVE BLENREP:
-
if you are allergic to belantamab mafodotin or any of the other
ingredients of this medicine
(listed in section 6).

CHECK WITH YOUR DOCTOR
if you think this applies to you.
WARNINGS AND PRECAUTIONS
EYE PROBLEMS
BLENREP can cause dry eyes, blurred vision or other eye problems.
You should have an eye examination by an eye specialist before
starting treatment and for the next
three doses of BLENREP. Yo

Lastnosti izdelka

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
BLENREP 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 100 mg of belantamab mafodotin.
After reconstitution, the solution contains 50 mg belantamab mafodotin
per mL.
Belantamab mafodotin
_ _
is an antibody-drug conjugate that contains belantamab, an
afucosylated
humanised monoclonal IgG1k antibody specific for B cell maturation
antigen (BCMA), produced
using recombinant DNA technology in a mammalian cell line (Chinese
Hamster Ovary) that is
conjugated with maleimidocaproyl monomethyl auristatin F (mcMMAF).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
Lyophilised white to yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BLENREP
_ _
is indicated as monotherapy for the treatment of multiple myeloma in
adult patients, who
have received at least four prior therapies and whose disease is
refractory to at least one proteasome
inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal
antibody, and who have
demonstrated disease progression on the last therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with BLENREP should be initiated and supervised by
physicians experienced in the
treatment of multiple myeloma.
Recommended supportive care
Patients should have an ophthalmic examination (including visual
acuity and slit lamp examination)
performed by an eye care professional at baseline, before the
subsequent 3 treatment cycles, and as
clinically indicated whilst on treatment (see section 4.4).
Physicians should advise patients to administe