BLENREP

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BELANTAMAB MAFODOTIN

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

L01XE39

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

BELANTAMAB MAFODOTIN 100 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE MANUFACTURING S.P.A., ITALY

Therapeutic area:

BELANTAMAB

Therapeutic indications:

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Authorization date:

2021-12-07

Patient Information leaflet

ةيبناجلا ضارعلأا )4
ضعب ىدل ةيبناج
ً
اضارعأ ببسي دق پيرنيلب لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا
بيرستلاب ةقلعتملا لعفلا دودر
امدنع ةيساسحلاب ةهيبش لعف دودر نم
اوساقي نأ صاخشلأا نم ددعل نكمي
.
ً
ابيرست نوقلتي
ىتح روطتت دق نكلو ،تاعاس وأ قئاقد عضب
نوضغ يف
ً
ابلاغ هذه روطتت
.جلاعلا دعب ةعاس 24
:ضارعلأا لمشت
د
ّ
روت
●
ةريرعشق
●
ةنوخس
●
سفنتلا يف تابوعص
●
بلقلا مظن عراست
●
مدلا طغض ضافخنإ
●
.لعف در كيدل نأ دقتعت تنك اذإ يروف لكشب
ةيبطلا ةدعاسملل هجوت ←
ىرخأ ةيبناج ضارعأ
:ةيتلآا ةيبناجلا ضارعلأا هذه نم
ً
ايأ تظحلا اذإ ةضرمملا وأ بيبطلا ربخأ
صاخشأ 10 لك نم 1 نم رثكأ ىدل هذه رهظت دق :
ً
ادج ةعئاش ةيبناج ضارعأ
،)ةينرقلا للاتعإ( نيعلا ةينرق يف
بارطضإ كلذ يف امب ،نينيعلا يف لكاشم
●
نينيعلا يف فافجو ةيؤرلا شوشت
يف 2 ةرقفلا يف "نينيعلا يف لكاشم" تحت
ةدوجوملا تامولعملا أرقإ
←
.ةرشنلا هذه
دعاست يتلاو ةيومدلا تاحيفصلا ىمست
يتلا مدلا ايلاخ دادعت ضافخنإ
●
.ةذاش ةفزنأو تامدك ببسي يذلا ،)ةيومدلا
تاحيفصلا ةلق( مدلا رثخت ىلع
ةرقفلا يف "ةذاشلا ةفزنلأاو تامدكلا"
تحت ةدوجوملا تامولعملا أرقإ
←
.ةرشنلا هذه يف 2
)
pneumonia
- نيتئرلا باهتلإ( نيتئرلا يف ثولت
●
ةنوخس
●
رقف( مدلا يف نيجسكلأا ل

Summary of Product characteristics

1
Summary of Product characteristics
1.
NAME OF THE MEDICINAL PRODUCT
BLENREP
_ _
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 for the treatment of adults with relapsed or
refractory multiple myeloma who
have received at least 4 prior therapies, including an anti-CD38
monoclonal antibody, a proteasome
inhibitor, and an immunomodulatory agent.
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 administer preservative-free
artificial tears at least 4 times a day
beginning on the first day of infusion and continuing until completion
of treatment as this may reduce
corneal symptoms (see section 4.4).
The marketing of Blenrep is subject to a risk mangment plan (RMP)
including Physician
guides and Patient guides that emphasizes important safety information
that physicians
and patients should be aware of before and during treatment. Please
explain to the patient
th