BESPONSA

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

INOTUZUMAB OZOGAMICIN

Dostopno od:

PFIZER PHARMACEUTICALS ISRAEL LTD

Koda artikla:

L01XC26

Farmacevtska oblika:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sestava:

INOTUZUMAB OZOGAMICIN 1 MG/VIAL

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

PHARMACIA & UPJOHN COMPANY , USA

Terapevtsko območje:

INOTUZUMAB OZOGAMICIN

Terapevtske indikacije:

BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).

Datum dovoljenje:

2023-08-31

Navodilo za uporabo

pfizer pharmaceuticals Israel | office:09-9700500 | fax:[phone] |
www.pfizer.co.il
PP-INO-ISR-0010
®
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
This card contains select safety information that is important for you
to know before
and during treatment with BESPONSA.
This card does not contain information about all of the side effects
that you could
experience during treatment with BESPONSA.
Besponsa
Patient Information Card
Additional safety information that requires
special attention
The use of BESPONSA is linked to several additional side effects.
You should contact your physician immediately if you have signs and
symptoms
of any of the following serious side effects:
●
Suppressed immune system: Signs and symptoms include infection, fever,
tendency to bruise easily or regular nose bleeds. A suppressed immune
system condition may be expressed by a low number of blood cells known
as neutrophils (occasionally accompanied by a fever), red blood cells,
white
blood cells, lymphocytes or blood components known as platelets.
●
Infusion-related reactions: Signs and symptoms include fever and
chills or
breathing difficulties during or shortly after the BESPONSA infusion.
●
Tumor lysis syndrome: This effect may be related to a wide range of
symptoms in the stomach and intestines (for example: nausea, vomiting,
diarrhea), the heart (for example: changes in regularity of the heart
rate), the
kidneys (for example: decreased urine output, blood in urine), and
nerves
and muscles (for example: spasms, cramps or muscle weakness).
●
QT interval prolongation: Signs and symptoms include dizziness or
fainting.
Not all patients will respond to BESPONSA in the same way. Some people
might experience more side effects than others and some not. Certain
side
effects may be mild and appear for a short time and others may be more
severe
and require medical care.
Please speak to your medical team if you suffer from any side effects
during treatment with BESPONSA, including side effects not specified
on
this card.
For full in

Lastnosti izdelka

Besponsa LPD, WC Israel, 25 Apr 2022 2021-0073929
1
1.
NAME OF THE MEDICINAL PRODUCT
BESPONSA powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg inotuzumab ozogamicin.
After reconstitution (see section 6.6), 1 mL of solution contains 0.25
mg inotuzumab ozogamicin.
Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of
a recombinant humanised
IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese
hamster ovary cells by
recombinant DNA technology) that is covalently linked to
N-acetyl-gamma-calicheamicin
dimethylhydrazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white, lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BESPONSA is indicated as monotherapy for the treatment of adults with
relapsed or refractory
CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).
Adult patients with
Philadelphia chromosome positive (Ph
+
) relapsed or refractory B cell precursor ALL should have
failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
BESPONSA should be administered under the supervision of a physician
experienced in the use of
cancer therapy and in an environment where full resuscitation
facilities are immediately available.
When considering the use of BESPONSA as a treatment for relapsed or
refractory B cell ALL,
baseline CD22 positivity of > 0% using a validated and sensitive assay
is required prior to initiating
treatment (see section 5.1).
For patients with circulating lymphoblasts, cytoreduction with a
combination of hydroxyurea,
steroids, and/or vincristine to a peripheral blast count ≤ 10,000/mm
3
is recommended prior to the first
dose.
PATIENT SAFETY INFORMATION CARD
The marketing of Besponsa is subject to a risk management plan (RMP)
including a 'Patient
safety information card'. The 'Patient safety inf