ELOXATIN oxaliplatin 200mg concentrate for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxaliplatin

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Oxaliplatin

Authorization status:

Registered

Patient Information leaflet

Page 1
ELOXATIN
®
_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.
Keep this leaflet with the medicine.
YOU MAY NEED TO READ IT AGAIN.
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Eloxatin is only available on a
prescription from you 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 agai

Summary of Product characteristics

eloxatin-ccdsv15-piv7-11sep19
Page 1 of 37
AUSTRALIAN PRODUCT INFORMATION – ELOXATIN (OXALIPLATIN)
1
NAME OF THE MEDICINE
Oxaliplatin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eloxatin powder for injection is available in the following strengths:
•
Oxaliplatin 50 mg
•
Oxaliplatin 100 mg
Eloxatin concentrate for injection is available in the following
strengths:
•
Oxaliplatin 50 mg
•
Oxaliplatin 100 mg
•
Oxaliplatin 200 mg
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 powder for injection contains oxaliplatin and lactose and the
concentrated solution for
injection contains oxaliplatin and water for injections.
3
PHARMACEUTICAL FORM
Powder for injection: White to off-white freeze-dried powder in a
clear glass vial
Concentrated solution for injection: A liquid contained in a clear
glass vial
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxaliplatin is indicated for adjuvant treatment of stage III (Duke’s
C) colon cancer, in
combination with fluoropyrimidine agent.
Oxaliplatin in combination with fluorouracil and folinic acid is
indicated for the treatment of
advanced colorectal cancer.
Oxaliplatin in combination with capecitabine, with or without
bevacizumab, is indicated for the
treatment of patients with metastatic colorectal cancer.
Oxaliplatin in combination with epirubicin and either capecitabine or
fluorouracil, is indicated
for: the treatment of patients with advanced oesophagogastric cancer.
eloxatin-ccdsv15-piv7-11sep19
Page 2 of 37
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
In combination with fluorouracil and folinic acid for adjuvant
treatment of colon cancer, the
recommended dose of oxaliplatin is 85 mg/m2 intravenously repeated
every two weeks for 12
cycles (6 months).
In combination with capecitabine for adjuvant treatment of colon
cancer, the recommended dose
of oxaliplatin is 130 mg/m2, administered as an intravenous infusion
over 2 hours on day 1 of a
thr