Besponsa 1mg powder for concentrate for solution for infusion vials

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Inotuzumab ozogamicin

Prieinama:

Pfizer Ltd

ATC kodas:

L01XC26

INN (Tarptautinis Pavadinimas):

Inotuzumab ozogamicin

Dozė:

1mg

Vaisto forma:

Powder for solution for infusion

Vartojimo būdas:

Intravenous

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: ; GTIN: 5013457012095

Pakuotės lapelis

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
BESPONSA 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
inotuzumab ozogamicin
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 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 ingredient 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

Prekės savybės

OBJECT 1
BESPONSA 1 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 12-Dec-2017 | Pfizer
Limited
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
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.
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, cytor