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
You must not receive Eloxatin if you are pregnant or breastfeeding.
Oxaliplatin may cause birth defects if you are being treated with it at the time of
conception or it is given to women who are already pregnant. Adequate contraception
is required during treatment with oxaliplatin. You should discuss this with your doctor.
Nursing mothers are advised not to breastfeed while receiving oxaliplatin, as the
effect of breast milk from such patients is unknown.
You must not receive Eloxatin if you have severe kidney disease.
What you should tell your doctor
You must tell your doctor if:
you have had a reaction to any other platinum compound
you have severe kidney disease
you have nerve damage (neuropathy)
you have any other medical condition that he or she is not aware of
you are taking any other medicines, including medicines that you have bought without
a prescription from a pharmacy, supermarket or health food shop.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
How Eloxatin is given
Eloxatin will be given to you as an infusion into one of your veins (this is called
an intravenous infusion). The infusion will be given over 2-6 hours.
The dose of Eloxatin is calculated according to your body surface area, which is calculated
from your weight and height. The usual dose is 85mg/m2 every two weeks, or 130mg/m2 every three weeks. Your doctor may change the dose in some circumstances.
Each course of treatment is called a cycle; your doctor will tell you how many cycles
you will receive.
Eloxatin will be used with one or more of the following drugs; capecitabine, bevacizumab,
epirubicin, fluorouracil (FU) and/or folinic acid. Your doctor will select the appropriate
combination of drugs for your treatment.
Eloxatin is not recommended in children.
While you are being given Eloxatin
Things you must do:
Avoid cold foods and drinks and cover skin prior to exposure to cold during or within
48 hours following being given oxaliplatin, since neurological effects may be brought
on or worsened by exposure to cold.
Contact your doctor immediately if you develop fever, particularly in association
with persistent diarrhoea or evidence of infection since this may indicate low blood
Contact your doctor if persistent vomiting, diarrhoea, signs of dehydration, cough
or breathing difficulties or signs of allergic reaction occur.
Visual disturbance is a rare side effect of Eloxatin. Contact your doctor if this
happens to you, and do not drive or use machinery until your vision is clear.
Tell your doctor or nurse as soon as possible if you do not feel well while Eloxatin
is being given to you. You should also tell your doctor if you do not feel well between
courses of Eloxatin.
All medicines can have side effects. It is important to understand the side effects
that Eloxatin may cause, even though you may not experience them. As well as the predictable
side effects of Eloxatin, there are other effects that occur much more rarely.
If you have any side effects or notice anything unusual it is important to inform
your doctor before your next treatment.
Your doctor will decide whether such effects are because of your treatment, and what
action needs to be taken.
This section explains the side effects of Eloxatin, and some of the checks made before
each treatment to prevent excessive side effects.
Before each treatment with Eloxatin you will be examined for any condition that may
be affected by chemotherapy (for example, infection, or loss of feeling). This will
include those conditions caused by previous treatment, those caused by your disease,
and those caused by other things.
Loss of feeling.
Eloxatin can affect nerves in the hands and feet. This is common soon after treatment
and can appear as tingling or numbness in the fingers or toes, and may be made worse
by cold temperatures or by contact with cold water or other cold objects. These symptoms
often go away between treatments, but may last longer and get worse with repeated
treatment. In some patients the limbs may become weak or painful. However, in most
patients these symptoms improve after treatment is stopped. Tell your doctor if any
of these things happen. Your doctor will examine you before treatment to see if you
Nausea and Vomiting.
Severe nausea and vomiting is uncommon with Eloxatin. Mild nausea and vomiting is
more common. Medication to prevent the sickness caused by Eloxatin will be given before
treatment, and may sometimes be continued after treatment.
Severe diarrhoea may occur during treatment with Eloxatin.
If you suffer from persistent or severe diarrhoea or vomiting, contact your doctor
urgently for treatment advice.
Low Blood Counts.
Eloxatin can affect the body's ability to make blood cells. There are three types
of blood cells checked before each treatment; platelets, which help control bleeding;
white blood cells, which help fight infection; and red blood cells which move oxygen
around the body. If your blood count is too low, your treatment may be postponed,
or the dose reduced.
Tell your doctor if you notice any bruising or abnormal bleeding, or have an infection.
These may be signs of a low blood count.
Some patients may experience a sudden, temporary feeling of difficulty with swallowing
or breathing. This sensation, if it occurs, usually happens during the infusion or
within hours after the infusion. It may be triggered by swallowing a cold drink. Although
unpleasant, this feeling does not last long, and goes away by itself.
Tell your doctor if this happens to you.
Other known side effects of Eloxatin are:
mucositis (sore lips or mouth ulcers)
changes to liver function
mild hair loss (alopecia)
inflammation around the injection site
abnormal tongue sensation
feeling of chest pressure
voice disturbance (rare)
loss of hearing (rare)
lung disorders (rare)
visual disturbance (rare)
infection in the body (symptoms include lightheadness, tiredness, fever, feeling unwell)
abnormal clotting followed by abnormal bleeding
abnormal changes to your heart rate
breakdown of muscle tissue causing muscle fibres to be released into the blood. Symptoms
include dark, red urine, decreased urine output, muscle stiffness or aching
shortness of breath and looking pale
serious lung infections. Symptoms include fever, chills, shortness of breath, and
a cough which produces yellow-green phlegm and occasionally blood
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice anything else that is making you feel unwell.
If you receive too much (overdose)
Your doctor will decide what dose of Eloxatin you need, and this will be given under
close supervision, usually in a hospital setting. The risk of an overdosage in these
circumstances is low. In the event of an overdose occurring, your doctor will decide
on the treatment necessary.
If you need to store Eloxatin before you take it with you to hospital, make sure it
is stored in a cool dry place where the temperature does not exceed 30°C. Do not freeze.
Do not use it after the expiry date (EXP) printed on the vial.
This is not all the information that is available on Eloxatin. If you have any more
questions or are not sure about anything ask your doctor or pharmacist.
What it looks like
Eloxatin comes as a concentrated solution in a glass vial.
A box contains 1 vial.
Each Eloxatin vial contains the active ingredient, oxaliplatin 50mg, 100mg or 200mg.
The concentrated solution for injection also contains water for injections.
Eloxatin is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Rd
Eloxatin 50mg/10mL concentrated solution for injection
AUST R 101701
Eloxatin 100mg/20mL concentrated solution for injection
AUST R 101658
Eloxatin 200mg/40mL concentrated solution for injection
AUST R 125804
These products are not marketed.
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