Besponsa

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Inotuzumab ozogamicin 1mg

Available from:

Pfizer New Zealand Limited

Dosage:

1 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Inotuzumab ozogamicin 1mg Excipient: Polysorbate 80 Sodium chloride Sucrose Trometamol

Prescription type:

Prescription

Therapeutic indications:

BESPONSA is indicated for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, 20mL amber Type 1 glass, with chlorobutyl stopper - 1 dose units - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2018-09-28

Patient Information leaflet

BESPONSA
®
1
BESPONSA
®
_Inotuzumab ozogamicin (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Besponsa.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving Besponsa
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BESPONSA IS
USED FOR
The active ingredient in Besponsa is
inotuzumab ozogamicin. It belongs
to a group of medicines called
antineoplastic agents that target
cancer cells.
Besponsa is used to treat adults with
acute lymphoblastic leukaemia
(ALL). ALL is a cancer of the blood
where the cells that help protect your
body from infection and foreign
materials (white blood cells) grow
uncontrollably.
This medicine works by stopping the
abnormal growth of these cells and
destroying them.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN _
The safety and effectiveness of this
medicine in children and adolescents
under the age of 18 years have not
been established.
BEFORE YOU ARE GIVEN
BESPONSA
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT RECEIVE BESPONSA IF YOU:
•
have had severe confirmed
venoocclusive disease (a
condition in which the blood
vessels in the liver become
damaged and blocked by blood
clots) or you currently have this
disease
•
have serious ongoing liver
disease (e.g., cirrhosis [a
condition in which the liver does
not function properly due to long-
term damage], nodular
regenerative hyperplasia [a
condition with signs and
symptoms of portal hypertension
that can be caused by chronic use
of medicines], active hepatitis [a
disease characterised by
inflammation of

Summary of Product characteristics

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Page 1 of 28
NEW ZEALAND DATA SHEET
WARNING:
•
HEPATOTOXICITY, INCLUDING FATAL AND LIFE
‐
THREATENING HEPATIC VENOOCCLUSIVE
DISEASE HAS OCCURRED IN PATIENTS TREATED WITH BESPONSA.
•
AN INCREASED RISK OF POST
‐
HAEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
NON
‐
RELAPSE MORTALITY HAS BEEN OBSERVED IN PATIENTS TREATED WITH BESPONSA.
1.
PRODUCT NAME
BESPONSA
®
1 mg powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg inotuzumab ozogamicin.
After reconstitution (see Section 6.6 Special precautions for disposal
and other handling),
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 List of
excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
BESPONSA is supplied for intravenous infusion as 1 mg (protein
equivalent) of white to off-
white lyophilised cake or powder in a single dose vial for
reconstitution and dilution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BESPONSA is indicated for the treatment of adults with relapsed or
refractory CD22
‐
positive
B-cell precursor acute lymphoblastic leukaemia (ALL).
4.2 DOSE AND METHOD OF ADMINISTRATION
Use of BESPONSA should be initiated and supervised by a physician
experienced in the
treatment of haematological malignancies.
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PREMEDICATION
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.
Premedication with a corticosteroid, antipyretic, and antihistamine is
recommended prior to
dosing
(see
Section
4.4
Special
warnings
an