PFIZER (PERTH) MITOZANTRONE (as hydrochloride) 25mg/12.5mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mitozantrone hydrochloride

Available from:

Pfizer Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

MITOZANTRONE INJECTION
(MY-TOE-ZAN-TRONE)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mitozantrone
Injection.
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 taking Mitozantrone
Injection against the benefits it is
expected to have for you.
This medicine is likely to be used
while you are in hospital.
IF POSSIBLE, PLEASE READ THIS LEAFLET
CAREFULLY BEFORE THIS MEDICINE IS
GIVEN TO YOU.
If you have any concerns about
taking this medicine, ask your doctor
or nurse.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MITOZANTRONE
INJECTION IS USED FOR
Mitozantrone (My-toe-ZAN-trone)
belongs to a group of medicines
called antineoplastic or cytotoxic
medicines. You may also hear of
these being called chemotherapy
medicines.
It is used to treat some types of
cancer, such as:
•
breast cancer, including breast
cancer which has spread to other
parts of the body
•
some types of leukaemia
•
non-Hodgkin's lymphoma, a
cancer of the lymph glands.
Mitozantrone is thought to work by
interfering with the growth of cancer
cells, which slows their growth and
destroys them. The growth of normal
cells in other parts of your body may
also be affected.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MITOZANTRONE
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor's prescription.
Mitozantrone Injection will be given
to you only by specially trained
personnel in a hospital environment.
Mitozantrone Injection is not
recommended for use in children as
there is not enough information on its
effects in children.
BEFORE YOU ARE GIVEN
MITOZANTRONE INJECTION
_WHEN IT MUST NOT BE USED_
YOU MUST NOT BE GIVEN
MITOZANTRONE INJECTION IF YOU HAVE
AN ALLERGY TO:
•
mitozantrone
•
any of the ingredients listed at the
end of this leaf

Summary of Product characteristics

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PRODUCT INFORMATION
MITOZANTRONE
® INJECTION (MITOZANTRONE HYDROCHLORIDE)
NAME OF THE MEDICINE
Mitozantrone (as hydrochloride)
DESCRIPTION
Mitozantrone hydrochloride is a hygroscopic dark blue solid, sparingly
soluble in water, slightly
soluble in methanol, practically insoluble in acetone, acetonitrile or
chloroform.
The structural formula is represented below.
O
O
NH
NH
OH
OH
N
HO
HO
N
H
H
,2HCl
Molecular formula:
C
22
H
30
Cl
2
N
4
O
6
Molecular weight:
517.4
CAS No:
70476-82-3
Mitozantrone Injection is a sterile, deep blue, aqueous, isotonic
solution containing Mitozantrone
Hydrochloride USP equivalent to 10mg, 20mg, 25mg and 30mg
mitozantrone, Sodium Chloride BP,
Disodium Edetate BP, Acetic Acid and Sodium Acetate in Water for
Injections BP.
PHARMACOLOGY
PHARMACODYNAMICS
CLASS OF DRUG:
Antineoplastic.
MODE OF ACTION:
Mitozantrone is a potent cytotoxic synthetic anthracenedione. Although
its
mechanism of action has not been fully determined, Mitozantrone is a
DNA-reactive agent. It has a
cytocidal effect on proliferating and nonproliferating cultured human
cells.
_In vitro_
studies suggest
that Mitozantrone is not cell cycle phase specific.
In animals, the principal toxic effects of Mitozantrone at doses
within the human therapeutic range are
reversible
myelosuppression
(manifested
predominantly
as
leucopenia;
erythropenia
and
thrombocytopenia are normally less severe) and lymphocytic depletion
of the lymphoid organs.
Gastrointestinal hemorrhage and congestion were noted in continuous
daily dosing studies but not in
the intermittent schedules to be used clinically.
In
dog
and
monkey
studies
with
Mitozantrone,
doxorubicin
was
studied
simultaneously
at
equileucopenic doses as a positive control for anthracycline induced
cardiomyopathy. Dogs given
Mitozantrone and untreated control dogs showed slight dilatation of
the sarcoplasmic reticulum which
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regressed over time. In monkeys, clinical s