2. What should I know before treatment with DBL Oxaliplatin?
Do not use if you have ever had an allergic reaction to oxaliplatin, any other platinum
compound or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions including severe kidney
disease, nerve damage and low blood counts; take any other medicines; or are pregnant
or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I am given DBL Oxaliplatin? in the full CMI.
3. What if I am taking other medicines?
4. How am I given DBL Oxaliplatin?
Your doctor will give you DBL Oxaliplatin as a slow injection (drip) into a vein and
decide how much you will be given and for how long. You may also be given other drugs
to help DBL Oxaliplatin work. More information can be found in Section
4. How am I given DBL Oxaliplatin? in the full CMI.
5. What should I know while receiving DBL Oxaliplatin?
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Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using DBL Oxaliplatin.
If you experience certain side effects, immediately inform your doctor so they can
review your treatment.
Both males and females must use reliable contraception.
Avoid cold food and drinks, and cover your skin before exposure to the cold during
or within 48 hours following your dose of DBL Oxaliplatin.
|
|
Things you should not do
|
Do not breastfeed while being treated with DBL Oxaliplatin.
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Driving or using machines
|
DBL Oxaliplatin may cause nausea, tiredness, weakness, numbness or vision loss/disturbances
in some people. If you have any of these symptoms, do not drive, operate machinery
or do anything else that could be dangerous.
|
|
Drinking alcohol
|
Talk to your doctor if you drink alcohol.
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6. Are there any side effects?
Side effects may include: Conjunctivitis; runny/blocked nose; weakness, fatigue; general
or joint pain; hair loss; abnormal tongue sensations or taste; flushing; hiccups;
sweating; nail problems; injection site redness, swelling, local pain; rash; constipation;
loss of appetite, weight loss or gain; indigestion; nausea, vomiting.
Serious side effects may include: Allergic reaction; loss of feeling, paralysis; problems
with palms of hands/soles of feet; depression; unusual/irregular heartbeat; mouth
ulcers; chest pain/discomfort; inability to sleep; headache; changes in mental state;
seizures; persistent vomiting; dehydration; bone pain; cough, breathing difficulties;
fever, chills; signs of infection; persistent or severe diarrhoea; signs of infection;
weakness or pain in the muscles, arms or legs; trouble swallowing, sore throat, jaw
spasms; jaundice; light headedness, dizziness, fainting; visual disturbances; abnormal
bruising or bleeding; severe stomach pain or cramping; dark coloured or little urine
(wee).
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
oxaliplatin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Oxaliplatin. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using DBL Oxaliplatin.
Where to find information in this leaflet:
1. Why am I being treated with DBL Oxaliplatin?
DBL Oxaliplatin contains the active ingredient oxaliplatin. DBL Oxaliplatin belongs to a group of medicines called antineoplastic or cytotoxic
medicines. You may also hear these being called chemotherapy medicines.
DBL Oxaliplatin is used to treat cancers of the colon and rectum (colorectal cancer
or bowel cancer).
It is often used in combination with other medicines, such as fluorouracil and folinic
acid, to treat cancer.
Oxaliplatin works by killing cancer cells and/or stopping cancer cells from growing
and multiplying.
Because cancer cells are similar to normal cells, anti-cancer drugs often have side
effects on normal cells.
Many side effects from anti-cancer drugs are predictable and can be prevented or lessened.
Your doctor will take all the precautions needed to reduce the side effects of treatment.
2. What should I know before I am given DBL Oxaliplatin?
Warnings
You should not be given DBL Oxaliplatin if:
you are allergic to oxaliplatin, any other platinum compound or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Symptoms of an allergic reaction to oxaliplatin may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
you have, or have had, any of the following medical conditions:
severe kidney disease
nerve damage
low blood count (white or red blood cells, or platelets)
you are pregnant or breastfeeding
Check with your doctor if you:
have any other medical conditions, including:
a history of reactions to any other platinum compound
blood disease or any infections
nerve damage (neuropathy)
stomachache or diarrhoea
lung disease
heart problems
liver or kidney disease
plan to have any vaccinations
any other medical condition that they are not aware of
take any medicines for any other condition
Before each treatment with DBL Oxaliplatin you will be examined for any condition
that may be affected by chemotherapy (e.g. 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.
DBL Oxaliplatin may affect fertility. Check with your doctor for advice on fertility
preservation before you begin treatment. During treatment, you may be at risk of developing
certain side effects. It is important you understand these risks and how to monitor
for them. See additional information under Section
6. Are there any side effects?
Pregnancy
Check with your doctor if you or your partner are pregnant or intend to become pregnant.
Oxaliplatin may cause birth defects if you are being treated with it at the time of
conception or it is given to you if you are already pregnant.
Women of childbearing potential being treated with DBL Oxaliplatin should use effective
contraception prior to and for at least 9 months after the last dose.
Men being treated with DBL Oxaliplatin should use effective contraception prior to
and for at least 6 months after the last dose if their female partner is of childbearing
potential.
Adequate contraception is required during treatment with DBL Oxaliplatin. You should
discuss this with your doctor.
Breastfeeding
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breastfeed if you are being treated with DBL Oxaliplatin, and for three months
after the last dose.
There is a possibility that your baby may be affected.
Use in Children
Safety and effectiveness have not been established with use of DBL Oxaliplatin in
children.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with DBL Oxaliplatin and affect how it works.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Oxaliplatin.
4. How am I given DBL Oxaliplatin?
How DBL Oxaliplatin is given
DBL Oxaliplatin is given as a single intravenous infusion (as a slow drip into a vein)
over 2 to 6 hours.
You may be given other drugs to help oxaliplatin work. These drugs are:
fluorouracil (another medicine used to treat cancer) and
leucovorin (also called folinic acid)
How much is given
Your doctor will decide how much DBL Oxaliplatin you should receive and the length
of time (number of cycles) for which you should receive it.
If you are given too much DBL Oxaliplatin
Your doctor will decide what dose of DBL Oxaliplatin you need, and this will be given
under close supervision, usually in a hospital. The risk of an over dose in these
circumstances is low. If you are given too much, your doctor will decide on the treatment
necessary. If you experience any side effects, tell your doctor or nurse immediately.
If you think that you have been given too much DBL Oxaliplatin, you should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning. You may
need urgent medical attention.
5. What should I know while being treated with DBL Oxaliplatin?
Things you should do
Avoid cold food and drinks, and cover your skin before exposure to the cold during
or within 48 hours following your dose of DBL Oxaliplatin.
Some side effects may be brought on or worsened by exposure to the cold.
Tell the surgeon or anaesthetist that you are using this medicine if you are planning
to have surgery. It may affect other medicines used during surgery.
Tell your doctor you are taking this medicine if you are about to have any blood tests.
It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Call your doctor straight away if you:
develop a fever and persistent diarrhoea or signs of an infection (e.g. chills, sweats,
sore throat, cough, a blocked nose etc.) or mouth ulcers. This may indicate you have
a low blood count.
develop persistent vomiting with diarrhoea, dehydration or thirst, cough or breathing
difficulties or signs of an allergic reaction.
develop tingling/numbness or weakness of the hands of feet or have trouble passing
urine (wee)
develop headache, altered mental functioning, seizures, hypertension, confusion, neurological
disturbances and abnormal vision from blurriness to blindness.
have unusual bruising or bleeding including blood in your urine (poo) or stool (poo)
muscle pain and swelling combined with fever, weakness or dark urine (wee)
have a sharp pain in your stomach that doesn't go away and blood in vomit or stool
(poo)
chest pain or fast/slow/irregular heartbeats
become pregnant while being on this medicine.
Remind any doctor, dentist or pharmacist you visit that you are using DBL Oxaliplatin.
Things to be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Oxaliplatin
affects you.
DBL Oxaliplatin may cause nausea, tiredness, weakness, numbness or vision loss/disturbances
in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Talk to your doctor if you drink alcohol.
Looking after your medicine
DBL Oxaliplatin will be stored at the hospital pharmacy or on the ward.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
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Side effects
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What to do
|
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Changes affecting your eyes, nose or mouth:
Discharge or swelling with itching of the eyes and crusty eyelids (conjunctivitis)
Abnormal tongue sensations
Altered taste
Runny or blocked nose
Changes to your body:
Weakness or fatigue
General pain or joint pain
Hair loss (alopecia)
Flushing, hiccups, excessive sweating
Problems with nails
Redness, swelling and local pain at the site of your injection
Changes to your skin:
Rash
Changes to your digestive system:
Constipation
Loss of appetite and weight loss or weight gain
Indigestion, nausea or vomiting
|
Speak to your doctor or nurse if you have any of these side effects and they worry
you.
|
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Changes to your body:
Loss of feeling
Tingling, numbness, burning, itching, swelling, pain, peeling or blistering of the
hands or feet
Rapid heart rate or irregular heartbeat
Sore lips or mouth ulcers
Back pain
Feeling of chest pressure
Inability to sleep
Pain, discomfort or feeling unwell:
Headache
Diarrhoea
Weakness or pain in the muscles, arms or legs
Bone pain
Trouble swallowing, sore throat or heartburn or spasm of the jaw
Changes to your mood:
Feelings of deep sadness, unworthiness or low mood
|
Tell your doctor as soon as possible if you notice any of these side effects.
|
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Changes to your body:
Sweating, fatigue, light-headedness, sudden dizziness or fainting.
Loss of balance and coordination, difficulty speaking, numbness or paralysis in the
face, leg or arm.
Yellowish discolouration of the skin or eyeballs
Pain, discomfort or feeling unwell:
Chest pain or discomfort which can spread to the arms, back, neck or jaw
Changes in mental state (confusion, thinking abnormal, altered consciousness) or seizures
Persistent vomiting, severe or persistent diarrhoea, signs of dehydration (e.g. feeling
very thirsty, dry mouth, dark or very little wee), cough or breathing difficulties
Signs of infection
Fever, chills
Bruising or any abnormal bleeding, including blood in your poo (black tarry stools),
blood in your wee or nose bleeds
Severe stomach pain, cramping, discomfort, fullness or swelling
Changes to your vision:
Visual disturbances or loss of eyesight
Changes when you go to the toilet:
Dark coloured wee (urine) or pain when weeing
Passing more, little or no wee.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/safety/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Oxaliplatin contains
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Active ingredient
(main ingredient)
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oxaliplatin
|
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Other ingredients
(inactive ingredients)
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tartaric acid
sodium hydroxide
water for injection
|
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Potential allergens
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n/a
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Do not take this medicine if you are allergic to any of these ingredients.
DBL Oxaliplatin does not contain lactose, sucrose, gluten, tartrazine or any other
azo dyes.
What DBL Oxaliplatin looks like
DBL Oxaliplatin is a sterile, preservative-free colourless or almost colourless solution
in a vial.
DBL Oxaliplatin is available in the following strengths:
100 mg/20 mL (AUST R 131758)
Who distributes DBL Oxaliplatin
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in December 2025.