BLINCYTO

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

BLINATUMOMAB

Tilgjengelig fra:

AMGEN EUROPE B.V.

ATC-kode:

L01XC19

Legemiddelform:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sammensetning:

BLINATUMOMAB 35 MCG / 1 VIAL

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

AMGEN EUROPE B.V., NETHERLANDS

Terapeutisk område:

BLINATUMOMAB

Indikasjoner:

• BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B- precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.• BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.• BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B precursor ALL as part of the consolidation therapy.Limitations of use: After failure of two previous treatments and with no CNS involvement.

Autorisasjon dato:

2021-06-30

Informasjon til brukeren

1
PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATION (
PREPARATIONS) -
1986
This medicine is dispensed
with a doctor’s prescription
only.
BLINCYTO
®
3
8.
5 MCG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ACTIVE INGREDIENT
The active substance is blinatumomab. Each vial of powder contains
38.5 mcg of
blinatumomab.
For Inactive ingredients and allergens in the medicine
–
see section 6
‘‘
Additional
information’’
.
READ THIS LEAFLET CAREFULLY AND UNTIL THE END BEFORE USING THIS
MEDICINE. This
leaflet contains concise information about the medicine. If you have
additional
questions, contact your doctor or pharmacist.
This medicine is prescribed for treating your illness. Do not pass it
on to others. It
may cause them harm even if it appears to you that their medical
condition is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
BLINCYTO is indicated as monotherapy for the treatment of adults with
CD19 positive relapsed or refractory B-precursor acute lymphoblastic
leukemia (ALL). Patients with Philadelphia chromosome positive
B-precursor
ALL should have failed treatment with at least 2 tyrosine kinase
inhibitors
(TKIs) and have no alternative treatment options.
•
BLINCYTO is indicated as monotherapy for the treatment of adults with
Philadelphia chromosome negative CD19 positive B-precursor ALL in
first or
second complete remission with minimal residual disease (MRD) greater
than
or equal to 0.1%.
•
BLINCYTO is indicated as monotherapy for the treatment of pediatric
patients
aged 1 year or older with Philadelphia chromosome negative CD19
positive
B-precursor ALL which is refractory or in relapse after receiving at
least two
prior therapies or in relapse after receiving prior allogeneic
hematopoietic
stem cell transplantation.
•
BLINCYTO is indicated as monotherapy for the treatment of pediatric
patients
aged 1 year or older with high-risk first relapsed Philadelphia
chromosome
negative CD19 positive B-precursor ALL as part of the consolidation
therapy.
In addition to the patient

Preparatomtale

1
_Revised in November 2023 according to MoHs guidelines. _
1.
NAME OF THE MEDICINAL PRODUCT
BLINCYTO 38.5 micrograms powder for concentrate and solution for
solution for infusion.
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 38.5 micrograms blinatumomab.
Reconstitution with water for injections results in a final
blinatumomab concentration of
12.5 micrograms/mL.
Blinatumomab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate and solution for solution for infusion.
BLINCYTO powder (powder for concentrate): White to off-white powder.
Solution (stabilizer): Colorless-to-slightly yellow, clear solution
with a pH of 7.0.
4.
CLINICAL PARTICULARS
Prescriber guide
This product is marketed with prescriber guide providing important
safety information. Please ensure
you are familiar with this material as it contains important safety
information.
Patient safety information materials: BLINCYTO Patient Alert Card and
BLINCYTO Guide
for Patients and Caregivers
This product is marketed with patient safety information materials
(patient card and patient guide).
Please explain to the patient the implications of this treatment
including the need for compliance.
Please also explain the signs of important adverse reactions and
instruct the patient when to seek
medical care.
4.1
Therapeutic indications
BLINCYTO
_ _
is indicated as monotherapy for the treatment of adults with CD19
positive relapsed or
refractory B-precursor acute lymphoblastic leukemia (ALL). Patients
with Philadelphia chromosome
positive B-precursor ALL should have failed treatment with at least 2
tyrosine kinase inhibitors (TKIs)
and have no alternative treatment options.
BLINCYTO is indicated as monotherapy for the treatment of adults with
Philadelphia chromosome
negative CD19 positive B-precursor ALL in first or second complete
remission with minimal residual
disease (MRD) greater than or equal to 0.1%.
BLINCYTO is i