Eloxatin

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oxaliplatin

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ELOXATIN(R)
1
ELOXATIN(R)
_Oxaliplatin concentrated solution for injection_
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET BEFORE YOU ARE GIVEN THIS MEDICINE.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Eloxatin 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 benefits and
risks. Your doctor has weighed the
risks of using Eloxatin against the
benefits it is expected to have for
you. 
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. 
WHAT ELOXATIN IS USED
FOR 
Eloxatin is used to treat cancer of the
oesophagus/stomach, large intestine
and rectum (colorectal cancer).
Eloxatin is used in combination with
other anti-cancer drugs; capecitabine,
bevacizumab, epirubicin, fluorouracil
(FU), and/or folinic acid. The active
ingredient in Eloxatin is called
oxaliplatin. 
Cancer cells are normal cells which
have changed so that they grow in an
uncontrolled way. Oxaliplatin works
by interfering with cancer cell
growth. Because of the similarities
between cancer cells and normal
cells, anti cancer drugs often have
unwanted effects on the body. 
Your doctors have decided to treat
you with Eloxatin because they
believe that the benefit of Eloxatin
treatment will be greater than the
unwanted effects. 
Many of the side effects from anti
cancer drugs are predictable and can
be prevented or lessened. Your
doctor and other staff will take all of
the precautions needed to reduce the
unwanted effects of treatment. 
Eloxatin is only available on a
prescription from your doctor. 
BEFORE YOU ARE GIVEN
ELOXATIN
_WHEN YOU MUST NOT RECEIVE IT_
YOU SHOULD NOT BE GIVEN ELOXATIN IF
YOU ARE ALLERGIC TO THE ACTIVE
INGREDIENT 'OXALIPLATIN'. 
If you have had an allergic reaction
to oxaliplatin before, you should not
receive it again. 
YOU MUST NOT RECEIVE ELOXATIN IF

Summary of Product characteristics

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 PRODUCT INFORMATION 
ELOXATIN
®

NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Oxaliplatin concentrated solution for injection. 
CHEMICAL STRUCTURE 
Oxaliplatin has the following chemical structure: 
CAS NUMBER 
61 825-94-3. 
DESCRIPTION 
Oxaliplatin is designated
chemically as [_SP_-4-2]-(1_R_,2_R_)-(cyclohexane-1,2-diamine-
k
2
_N,N_´(oxalato(2-)-k
2
_O_
1
,_O_
2
]platinum (II) 
The empirical formula of oxaliplatin is C
8
H
14
N
2
O
4
Pt and its molecular weight is 397.3. 
Oxaliplatin is a white to off-white crystalline
powder. It is slightly soluble
in water, very slightly soluble 
in methanol and practically insoluble in ethanol. 
Eloxatin concentrated solution for injection
also contains water for injections. 
PHARMACOLOGY 
PHARMACODYNAMICS 
Oxaliplatin is an antineoplastic drug belonging to a
new class of platinum based compounds in which 
the platinum atom is complexed with 1,2-diaminocyclohexane
(DACH) and an oxalate group.  
Oxaliplatin is a single enantiomer, the Cis-[oxalato(trans-
λ-1,2-DACH) platinum]. 
Oxaliplatin exhibits a wide spectrum of both _in vitro_  cytotoxicity and _in vivo_  antitumour activity in a 
variety of tumour model systems, including human
colorectal cancer models. Oxaliplatin also 
demonstrates _in vitro _and_ in vivo_ activity in
various cisplatin resistant models. 
A synergistic cytotoxic action has been observed in
combination with fluorouracil both _in vitro_ and _in _
_vivo_. 
Studies on the mechanism of action of oxaliplatin, although not completely elucidated, show that the 
aqua-derivatives resulting from the biotransformation
of oxaliplatin interact with DNA to form both 
inter-  and intra-strand cross links, resulting in the disruption of DNA synthesis leading to cytotoxic 
and antitumour effects. 
eloxatin-sol-piv1-7aug12