Besponsa

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

Inotuzumab ozogamicin

Beschikbaar vanaf:

Pfizer Europe MA EEIG

ATC-code:

L01FX

INN (Algemene Internationale Benaming):

inotuzumab ozogamicin

Therapeutische categorie:

Antineoplastic agents

Therapeutisch gebied:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

therapeutische indicaties:

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).

Product samenvatting:

Revision: 9

Autorisatie-status:

Authorised

Autorisatie datum:

2017-06-28

Bijsluiter

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
BESPONSA 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
inotuzumab ozogamicin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BESPONSA is and what it is used for
2.
What you need to know before you are given BESPONSA
3.
How BESPONSA is given
4.
Possible side effects
5.
How to store BESPONSA
6.
Contents of the pack and other information
1. WHAT BESPONSA IS AND WHAT IT IS USED FOR
The active substance in BESPONSA is inotuzumab ozogamicin. This
belongs to a group of medicines
that target cancer cells. These medicines are called antineoplastic
agents.
BESPONSA is used to treat adults with acute lymphoblastic leukaemia.
Acute lymphoblastic
leukaemia is a cancer of blood where you have too many white blood
cells. BESPONSA is intended
for the treatment of acute lymphoblastic leukaemia for adult patients
who have previously tried other
treatments and for whom those treatments have failed.
BESPONSA acts by attaching to cells with a protein called CD22.
Lymphoblastic leukaemia cells
have this protein. Once attached to the lymphoblastic leukaemia cells,
the medicine delivers a
substance into the cells that interferes with the cells’ DNA and
eventually kills them.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BESPONSA
DO NOT USE BESPONSA IF YOU

are allergic to inotuzumab ozogamicin or any of the other ingredients
of this medicine (listed in
section 6).

have previously had severe venoocclusive disease (a condition in which
the blood vessels in the
liver become damaged and blocked by blood clots) which was confirmed
or have ongoing
venoocclusive disease.

hav

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BESPONSA 1 mg 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.
Pre-medication with a corticosteroid, antipyretic, and antihistamine
is recommended prior to dosing
(see section 4.4).
For patients with a high tumour burden, pre-medicati